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    Clinical Trial Results:
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, WITHIN-SUBJECT, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-06473871 IN REDUCING HYPERTROPHIC SKIN SCARRING

    Summary
    EudraCT number
    		 2012-004355-37
    Trial protocol
    		 DE   HU   ES   NL  
    Global end of trial date
    07 May 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Apr 2016
    First version publication date
    17 Apr 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B5301001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01730339
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States,  NY 10017
    Public contact
    Pfizer Call Center,, Pfizer Inc, 001 800­718­1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer Call Center, Pfizer Inc, 001 800­718­1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 May 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of PF-06473871 compared to placebo, in reducing the severity of skin scarring in subjects undergoing an elective revision of hypertrophic scars resulting from prior breast surgery.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Dec 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United States: 93
    Worldwide total number of subjects
    100
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    100
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 103 subjects were randomized into the study. Of these, 100 subjects received at least 1 dose of study drug and were included in the modified intent to treat (mITT) and safety population.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PF-06473871/Placebo (4* 5 mg/cm)
    Arm description
    		 Subjects with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06473871
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received 4 intradermal injections of PF­06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received 4 intradermal injections of placebo matched to PF­06473871 at Week 2, 5, 8 and 11 on another breast.

    Arm title
    		 PF-06473871/Placebo (3* 5 mg/cm)
    Arm description
    		 Subjects with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06473871
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received 3 intradermal injections of PF­06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    Subjects received 3 intradermal injections of placebo matched to PF­06473871 at Week 2, 5 and 8 on another breast.

    Number of subjects in period 1
    		PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm)
    Started
    45
    55
    Completed
    40
    52
    Not completed
    5
    3
         Consent withdrawn by subject
    3
    2
         Un-specified
    1
    -
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-06473871/Placebo (4* 5 mg/cm)
    Reporting group description
    		 Subjects with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.

    Reporting group title
    PF-06473871/Placebo (3* 5 mg/cm)
    Reporting group description
    		 Subjects with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.

    Reporting group values
    		 PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm) Total
    Number of subjects
    		 45 55
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 38.2 ( 8.55 ) 37.6 ( 9.64 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 44 53 97
        Male
    		 1 2 3
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 3 0 3
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 27 39 66
        White
    		 13 16 29
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 2 0 2
    Study Specific Characteristic |
    Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the subject’s scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar).
    Units: units on scale
        arithmetic mean (standard deviation)
    		 6.62 ( 1.545 ) 6.88 ( 1.277 ) -
    Study Specific Characteristic |
    Subject global assessment was performed using the overall opinion question of the POSAS scale. Subjects were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).
    Units: units on scale
        arithmetic mean (standard deviation)
    		 9 ( 1.219 ) 8.49 ( 1.617 ) -
    Study Specific Characteristic |
    Physician rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within subject treatment difference was assessed between the treatment regimens each subject received.
    Units: units on scale
        arithmetic mean (standard deviation)
    		 3.97 ( 0.682 ) 3.98 ( 0.725 ) -
    Study Specific Characteristic |
    Subjects rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within subject treatment difference was assessed between the treatment regimens each subject received.
    Units: units on scale
        arithmetic mean (standard deviation)
    		 4.24 ( 0.648 ) 4.28 ( 0.637 ) -

    End points

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    End points reporting groups
    Reporting group title
    PF-06473871/Placebo (4* 5 mg/cm)
    Reporting group description
    		 Subjects with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.

    Reporting group title
    PF-06473871/Placebo (3* 5 mg/cm)
    Reporting group description
    		 Subjects with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.

    Subject analysis set title
    Group 1: PF-06473871: (4* 5 mg/cm)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.

    Subject analysis set title
    Group 1: Placebo 4* 5 mg/cm
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast

    Subject analysis set title
    Group 2: PF-06473871: (3* 5 mg/cm)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.

    Subject analysis set title
    Group 2: Placebo 3* 5 mg/cm
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects who received 3 intradermal injections of PF-06473871 on one breast, also received 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.

    Subject analysis set title
    Group 1: Placebo 4* 5 mg/cm
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.

    Subject analysis set title
    Group 2: Placebo 3* 5 mg/cm
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.

    Subject analysis set title
    PF-06473871/Placebo (4* 5 mg/cm)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm, (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.

    Subject analysis set title
    PF-06473871/Placebo (4* 5 mg/cm)
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Subjects with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.

    Primary: Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)

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    End point title
    		 Physician Global Assessment Using Physician Overall Opinion Question of Patient and Observer Scar Assessment Scale (POSAS)
    End point description
    Physician global assessment was performed using the overall opinion question of the POSAS scale. Physicians were asked to rate the severity of the subjects scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (worst imaginable scar). Within subject treatment difference was assessed between the treatment regimens each subject received. Modified Intent To Treat (mITT) population included all subjects who were randomized and received at least 1 dose of investigational product. Here, N (number of subject analyzed) signifies those subjectswho were evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 Group 1: PF-06473871: (4* 5 mg/cm) Group 1: Placebo 4* 5 mg/cm Group 2: PF-06473871: (3* 5 mg/cm) Group 2: Placebo 3* 5 mg/cm
    Number of subjects analysed
    43
    43
    53
    53
    Units: units on scale
        least squares mean (standard error)
    4 ( 0.3 )
    4.68 ( 0.27 )
    4.61 ( 0.29 )
    4.86 ( 0.28 )
    Statistical analysis title
    		 Group1: PF-¬06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0219
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.68
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 1.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Notes
    [1] - Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF­-06473871. 
    Statistical analysis title
    		 Group 2: PF-06473871: 3*5 vs Placebo 3*5 mg/cm  
    Statistical analysis description
    A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    P-value
    		 = 0.4038
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.24
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Notes
    [2] - Difference is calculated as Placebo minusPF­-06473871. A positive difference favors PF-­06473871.  

    Secondary: Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)

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    End point title
    		 Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS)
    End point description
    Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable). Within subject treatment difference was assessed between the treatment regimens each subject received. Data for overall opinion scale score at Week 24 was not presented in this outcome measure because the data was reported separately under primary outcome measure 1. Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871. mITT population included all subject who were randomized and received at least 1 dose of investigational product. Here,"n""= subject who were evaluable at given time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 8, 11, 18, 24
    End point values
    		 Group 1: PF-06473871: (4* 5 mg/cm) Group 1: Placebo 4* 5 mg/cm Group 2: PF-06473871: (3* 5 mg/cm) Group 2: Placebo 3* 5 mg/cm
    Number of subjects analysed
    45
    45
    55
    55
    Units: units on scale
    least squares mean (standard error)
        Vascularity: Week 8 (n=43,43,51,51)
    3.63 ( 0.24 )
    3.51 ( 0.25 )
    3.95 ( 0.24 )
    3.79 ( 0.24 )
        Vascularity: Week 11 (n=43,43,52,52)
    3.64 ( 0.25 )
    3.83 ( 0.26 )
    3.76 ( 0.26 )
    3.83 ( 0.25 )
        Vascularity: Week 18 (n=40,40,52,52)
    3.31 ( 0.27 )
    3.73 ( 0.28 )
    3.49 ( 0.27 )
    3.84 ( 0.26 )
        Vascularity: Week 24 (n=43,43,53,53)
    3.08 ( 0.27 )
    3.4 ( 0.28 )
    3.34 ( 0.27 )
    3.55 ( 0.27 )
        Pigmentation: Week 8 (n=43,43,51,51)
    3.42 ( 0.23 )
    3.53 ( 0.23 )
    3.49 ( 0.2 )
    3.43 ( 0.19 )
        Pigmentation: Week 11 (n=43,43,52,52)
    3.84 ( 0.27 )
    3.73 ( 0.27 )
    3.8 ( 0.23 )
    3.53 ( 0.22 )
        Pigmentation: Week 18 (n=40,40,52,52)
    3.85 ( 0.29 )
    3.88 ( 0.29 )
    3.73 ( 0.24 )
    3.75 ( 0.23 )
        Pigmentation: Week 24 (n=43,43,53,53)
    3.84 ( 0.29 )
    3.99 ( 0.29 )
    4.16 ( 0.25 )
    4.12 ( 0.24 )
        Thickness: Week 8 (n=43,43,51,51)
    3.38 ( 0.23 )
    3.56 ( 0.24 )
    3.59 ( 0.22 )
    3.56 ( 0.22 )
        Thickness: Week 11(n=43,43,52,52)
    3.58 ( 0.26 )
    3.98 ( 0.26 )
    4.01 ( 0.25 )
    3.82 ( 0.24 )
        Thickness: Week 18 (n=40,40,52,52)
    3.67 ( 0.32 )
    4.61 ( 0.32 )
    4.18 ( 0.3 )
    4.39 ( 0.29 )
        Thickness: Week 24 (n=43,43,53,53)
    3.9 ( 0.32 )
    4.58 ( 0.33 )
    4.63 ( 0.31 )
    4.77 ( 0.3 )
        Relief: Week 8 (n=43,43,51,51)
    3.19 ( 0.23 )
    3.58 ( 0.24 )
    3.48 ( 0.24 )
    3.37 ( 0.22 )
        Relief: Week 11(n=43,43,52,52)
    3.63 ( 0.26 )
    3.85 ( 0.27 )
    3.89 ( 0.27 )
    3.7 ( 0.25 )
        Relief: Week 18 (n=40,40,52,52)
    3.75 ( 0.31 )
    4.48 ( 0.32 )
    3.99 ( 0.31 )
    4.08 ( 0.28 )
        Relief: Week 24 (n=43,43,53,53)
    3.87 ( 0.3 )
    4.39 ( 0.31 )
    4.38 ( 0.29 )
    4.53 ( 0.27 )
        Pliability: Week 8 (n=43,43,51,51)
    3.55 ( 0.25 )
    3.84 ( 0.24 )
    3.57 ( 0.22 )
    3.55 ( 0.21 )
        Pliability: Week 11(n=43,43,52,52)
    3.71 ( 0.28 )
    4.02 ( 0.27 )
    4.01 ( 0.25 )
    3.65 ( 0.24 )
        Pliability: Week 18 (n=40,40,52,52)
    3.46 ( 0.31 )
    4.19 ( 0.3 )
    3.86 ( 0.27 )
    3.84 ( 0.26 )
        Pliability: Week 24 (n=43,43,53,53)
    3.73 ( 0.34 )
    4.27 ( 0.32 )
    4.05 ( 0.3 )
    4.54 ( 0.29 )
        Surface Area: Week 8 (n=43,43,51,51)
    3.42 ( 0.25 )
    3.59 ( 0.23 )
    3.48 ( 0.22 )
    3.55 ( 0.21 )
        Surface Area: Week 11 (n=43,43,52,52)
    3.55 ( 0.27 )
    4.06 ( 0.25 )
    3.91 ( 0.23 )
    3.76 ( 0.22 )
        Surface Area: Week 18 (n=40,40,52,52)
    3.97 ( 0.31 )
    4.61 ( 0.29 )
    4.33 ( 0.26 )
    4.32 ( 0.25 )
        Surface Area: Week 24 (n=43,43,53,53)
    4.05 ( 0.33 )
    4.73 ( 0.3 )
    4.55 ( 0.28 )
    4.78 ( 0.27 )
        Overall Opinion: Week 8 (n=43,43,51,51)
    3.5 ( 0.22 )
    3.74 ( 0.2 )
    3.66 ( 0.22 )
    3.75 ( 0.21 )
        Overall Opinion: Week 11 (n=43,43,52,52)
    3.82 ( 0.25 )
    4.05 ( 0.24 )
    4.13 ( 0.25 )
    3.91 ( 0.24 )
        Overall Opinion: Week 18 (n=40,40,52,52)
    3.86 ( 0.29 )
    4.68 ( 0.27 )
    4.35 ( 0.28 )
    4.47 ( 0.27 )
    Statistical analysis title
    		 Group1: PF-¬06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.19
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Vascularity: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.16
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Group1: PF-¬06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Vascularity: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.36
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.42
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.07
         upper limit
    		 0.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Vascularity: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.05
         upper limit
    		 0.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.33
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Vascularity: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.12
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Pigmentation: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.17
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Pigmentation: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.27
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.41
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Pigmentation: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 0.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.53
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Pigmentation: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 0.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.24
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Thickness: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.42
         upper limit
    		 0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 0.84
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.27
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Thickness: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.62
         upper limit
    		 0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.94
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 1.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.33
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Thickness: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.31
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.68
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 1.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Thickness: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.38
         upper limit
    		 0.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.32
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.39
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.01
         upper limit
    		 0.78
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.24
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Relief: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 0.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.27
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Relief: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.63
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.74
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 1.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.31
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Relief: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.09
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 0.59
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.52
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 1.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Relief: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 0.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.29
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Pliability: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.39
         upper limit
    		 0.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.31
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.74
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Pliability: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.76
         upper limit
    		 0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.73
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Pliability: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 0.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.27
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.53
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.01
         upper limit
    		 1.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.31
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Pliability: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.49
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.17
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.62
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.27
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Surface Area: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.08
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.43
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.51
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.02
         upper limit
    		 1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Surface Area: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Surface Area: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.64
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.34
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Surface Area : Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 0.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Surface Area: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.69
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.09
         upper limit
    		 1.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.36
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Surface Area: week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.23
         upper limit
    		 0.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Overall Opinion: Week 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2778
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.24
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Overall Opinion: Weekl 8 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6888
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.09
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3515
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Overall Opinion: Weekl 11 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.3788
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 0.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0044
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.82
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Overall Opinion: Weekl 18 A total sample size of 100 (accounting for approximately 10% drop rate) that is approximately 50 per group at one sided 0.05 level with delta of 1.5 points with standard deviation of 2 provided at least 80% power to detect a difference from placebo using a paired test. Statistical significance was tested at the two-sided significance level of 0.1, without adjusting for multiplicity.
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6848
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28

    Secondary: Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)

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    End point title
    		 Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS)
    End point description
    Patient global assessment was performed using the overall opinion question of the POSAS scale. Subjects were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin). Within subject treatment difference was assessed between the treatment regimens each subject received. mITT population included all subjects who were randomized and received at least 1 dose of investigational product. Here, "n""= subjects who were evaluable at given time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 8, 11, 18, 24
    End point values
    		 Group 1: PF-06473871: (4* 5 mg/cm) Group 2: PF-06473871: (3* 5 mg/cm) Group 1: Placebo 4* 5 mg/cm Group 2: Placebo 3* 5 mg/cm
    Number of subjects analysed
    45
    55
    45
    55
    Units: units on scale
    least squares mean (standard error)
        Week 8: (n=43,43,51,51)
    5.38 ( 0.33 )
    5.09 ( 0.32 )
    5.48 ( 0.31 )
    5.2 ( 0.29 )
        Week 11: (n=43,43,52,52)
    5.58 ( 0.33 )
    4.52 ( 0.32 )
    5.59 ( 0.32 )
    4.73 ( 0.3 )
        Week 18: (n=40,40,52,52)
    5.34 ( 0.38 )
    5.18 ( 0.36 )
    5.78 ( 0.36 )
    5.18 ( 0.33 )
        Week 24: (n=43,43,53,53)
    5.65 ( 0.39 )
    5.33 ( 0.38 )
    5.94 ( 0.37 )
    5.15 ( 0.35 )
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.7552
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.44
         upper limit
    		 0.64
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.32
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.6605
    Method
    		 Repeated measures model
    Parameter type
    		 LS mean difference
    Point estimate
    0.11
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.3
         upper limit
    		 0.52
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9842
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 0.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.33
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.401
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2491
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.44
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 1.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.38
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.998
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.47
         upper limit
    		 0.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.473
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.28
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.37
         upper limit
    		 0.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.5413
    Method
    		 Repeated measures model
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.67
         upper limit
    		 0.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3

    Secondary: Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score

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    End point title
    		 Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptoms and Appearance Domains Score
    End point description
    PR-SEQ questionnaire consisted of 30 different attributes of scars, included following four dimensions: appearance-5 attributes, symptoms-3 attributes, bothersomeness-8 attributes, and impacts on the quality of life (physical and emotional wellbeing-14 attributes). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version, included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each domain score ranged from 0 to 100, with higher scores indicating higher severity. Subject treatment difference was assessed between the treatment regimens each subject received. mITT population included all subjects who were randomized and received at least 1 dose of investigational product. Here "n"= subjects who were evaluable at given time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 8, 24
    End point values
    		 Group 1: PF-06473871: (4* 5 mg/cm) Group 2: PF-06473871: (3* 5 mg/cm) Group 1: Placebo 4* 5 mg/cm Group 2: Placebo 3* 5 mg/cm
    Number of subjects analysed
    45
    55
    45
    55
    Units: units on scale
    least squares mean (standard error)
        Appearance: Week 8: (n=43,43,53,53)
    34.95 ( 2.38 )
    34.5 ( 2.2 )
    36.27 ( 2.27 )
    34.14 ( 2.2 )
        Appearance: Week 24: (n=43,43,54,54)
    43.55 ( 3.32 )
    42.41 ( 3.04 )
    47.37 ( 3.16 )
    42.56 ( 3.04 )
        Symptoms: Week 8: (n=43,43,53,53)
    17.89 ( 2.62 )
    18.46 ( 2.71 )
    17.19 ( 2.34 )
    16.92 ( 2.47 )
        Symptoms: Week 24: (n=43,43,54,54)
    13.74 ( 2.75 )
    18.22 ( 2.81 )
    15.49 ( 2.45 )
    17.09 ( 2.57 )
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    1.32
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.28
         upper limit
    		 5.92
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.76
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Appearance: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 LS mean difference
    Point estimate
    -0.36
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -3.63
         upper limit
    		 2.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.97
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    3.82
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 10.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.85
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Appearance: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.16
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.37
         upper limit
    		 4.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.72
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.34
         upper limit
    		 2.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.19
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Symptoms: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -1.54
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.53
         upper limit
    		 1.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.8
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    1.75
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.07
         upper limit
    		 5.58
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.3
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Symptoms: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -1.13
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -4.24
         upper limit
    		 1.99
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.87

    Secondary: Physician and Subject Photoguide Scar Assessment Scale Score

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    End point title
    		 Physician and Subject Photoguide Scar Assessment Scale Score
    End point description
    Physician and subjects rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe). Within subject treatment difference was assessed between the treatment regimens each subject received. mITT population included all subjects who were randomized and received at least 1 dose of investigational product. Here, "n""= subjects who were evaluable at given time point for each arm, respectively.
    End point type
    Secondary
    End point timeframe
    Week 8, 11, 18, 24
    End point values
    		 Group 1: PF-06473871: (4* 5 mg/cm) Group 2: PF-06473871: (3* 5 mg/cm) Group 1: Placebo 4* 5 mg/cm Group 2: Placebo 3* 5 mg/cm
    Number of subjects analysed
    45
    55
    45
    55
    Units: units on scale
    least squares mean (standard error)
        Physician: Week 8 (n=43,43,52,52)
    2.35 ( 0.15 )
    2.24 ( 0.16 )
    2.45 ( 0.14 )
    2.28 ( 0.14 )
        Physician: Week 11 (n=43,43,53,53)
    2.42 ( 0.15 )
    2.58 ( 0.16 )
    2.71 ( 0.14 )
    2.48 ( 0.14 )
        Physician: Week 18 (n=40,40,53,53)
    2.48 ( 0.15 )
    2.7 ( 0.16 )
    3.05 ( 0.14 )
    2.74 ( 0.14 )
        Physician: Week 24 (n=43,43,54,54)
    2.6 ( 0.15 )
    3 ( 0.16 )
    3.03 ( 0.14 )
    3.07 ( 0.14 )
        Participant: Week 8 (n=43,43,52,52)
    2.41 ( 0.16 )
    2.28 ( 0.15 )
    2.51 ( 0.16 )
    2.25 ( 0.14 )
        Participant: Week 11 (n=43,43,53,53)
    2.65 ( 0.16 )
    2.48 ( 0.15 )
    2.66 ( 0.16 )
    2.56 ( 0.14 )
        Participant: Week 18 (n=39,39,53,53)
    2.38 ( 0.16 )
    2.8 ( 0.15 )
    2.8 ( 0.17 )
    2.79 ( 0.14 )
        Participant: Week 24 (n=43,43,54,54)
    2.75 ( 0.16 )
    2.75 ( 0.15 )
    2.95 ( 0.16 )
    2.89 ( 0.14 )
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group 2: PF­06473871: 3* 5 vs Placebo 3* 5 mg/cm
    Statistical analysis description
    Physician: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.22
         upper limit
    		 0.29
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.16
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.29
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 0.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Physician: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 0.15
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.57
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 0.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Physician: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.05
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.21
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.43
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 0.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Physician: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.32
    Variability estimate
    Standard deviation
    Dispersion value
    0.15
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.39
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Participant: Week 8: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.02
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.23
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.29
         upper limit
    		 0.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Participant: Week 11: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.07
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.18
         upper limit
    		 0.33
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.42
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Participant: Week 18: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    -0.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.27
         upper limit
    		 0.24
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15
    Statistical analysis title
    		 Group1: PF-06473871: 4*5 vs Placebo 4*5 mg/cm
    Statistical analysis description
    Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 1: PF-06473871: (4* 5 mg/cm) v Group 1: Placebo 4* 5 mg/cm
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.18
    Statistical analysis title
    		 Group 2: PF­06473871: 3*5 vs Placebo 3*5 mg/cm
    Statistical analysis description
    Participant: Week 24: Difference is calculated as Placebo minus PF-06473871. A positive difference favors PF-06473871
    Comparison groups
    Group 2: PF-06473871: (3* 5 mg/cm) v Group 2: Placebo 3* 5 mg/cm
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Least Square mean difference
    Point estimate
    0.15
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -0.11
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.15

    Other pre-specified: Number of Subjects With Clinically Significant Vital Sign Abnormalities

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    End point title
    		 Number of Subjects With Clinically Significant Vital Sign Abnormalities
    End point description
    Vital Sign included pulse rate, systolic blood pressure, diastolic blood pressure, and weight. Safety population included all subjects who received at least 1 dose of investigational product.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 24
    End point values
    		 PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm)
    Number of subjects analysed
    45
    55
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Abnormal Physical Examinations

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    End point title
    		 Number of Subjects With Abnormal Physical Examinations
    End point description
    Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), respiratory, cardiovascular, abdomen - liver and kidney, musculoskeletal, gastrointestinal, genitourinary, and neurological systems. Safety population included all subjects who received at least 1 dose of investigational product.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 24
    End point values
    		 PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm)
    Number of subjects analysed
    45
    55
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Electrocardiogram Findings

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    End point title
    		 Number of Subjects With Electrocardiogram Findings
    End point description
    Following parameters were assessed: heart rate, PR Interval, QRS Interval, QT Interval, and Fridericia's Correction Formula (QTcF) interval. Electrocardiogram Results were reported as normal, abnormal, not clinically significant (NCS) and abnormal and clinically significant (CS) as determined by investigator. Safety population included all subjects who received at least 1 dose of investigational product. Here, "n""= subjects who were evaluable at given time point for each arm, respectively.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Week 11
    End point values
    		 PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm)
    Number of subjects analysed
    45
    55
    Units: subjects
        Baseline: Normal (n=45,55)
    38
    43
        Baseline: Abnormal, NCS (n=45,55)
    7
    12
        Baseline: Abnormal , CS (n=45,55)
    0
    0
        Week 11: Normal (n=42,53)
    33
    43
        Week 11: Abnormal, NCS (n=42,53)
    9
    10
        Week 11: Abnormal, CS (n=42,53)
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Treatment Emergent Adverse Events (AEs) of Special Interest

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    End point title
    		 Number of Subjects With Treatment Emergent Adverse Events (AEs) of Special Interest
    End point description
    Treatment Emergent Adverse Events (AEs) of special interest included injection site erythema, maculopapular rash, pruritus, bronchospasm, dyspnea, cough, fever and diarrhea. Safety population included all subjects who received at least 1 dose of investigational product.  Here, "N" (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 24
    End point values
    		 PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm)
    Number of subjects analysed
    45
    55
    Units: subjects
    3
    9
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities

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    End point title
    		 Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Related to Laboratory Abnormalities
    End point description
    An adverse event (AE) was any untoward medical occurrence in a subjects who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pre-treatment state. TEAEs related to laboratory abnormalities are reported. Safety population included all subjects who received at least 1 dose of investigational product.
    End point type
    Other pre-specified
    End point timeframe
    Baseline up to Week 24
    End point values
    		 PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm)
    Number of subjects analysed
    45
    55
    Units: subjects
        Leukopenia
    0
    1
        Hyperbilrubinemia
    0
    1
        Amylase increased
    1
    1
        Blood creatine phosphokinase (CPK) increased
    2
    6
        Blood glucose increased
    0
    1
        Blood lactate dehydrogenase (LDH) increased
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 24
    Adverse event reporting additional description
    There was no overall separate placebo group for safety assessment as each subject received both placebo as well as active drug. AE assessment was done between those who received 3 versus 4 doses of active drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    PF-06473871/Placebo (4* 5 mg/cm)
    Reporting group description
    		 Subjects with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.

    Reporting group title
    PF-06473871/Placebo (3* 5 mg/cm)
    Reporting group description
    		 Subjects with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.

    Serious adverse events
    		 PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 45 (0.00%)
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 PF-06473871/Placebo (4* 5 mg/cm) PF-06473871/Placebo (3* 5 mg/cm)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 45 (66.67%)
    35 / 55 (63.64%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    3 / 45 (6.67%)
    5 / 55 (9.09%)
         occurrences all number
    3
    5
    Injection site pain
         subjects affected / exposed
    10 / 45 (22.22%)
    9 / 55 (16.36%)
         occurrences all number
    10
    9
    Injection site pruritus
         subjects affected / exposed
    3 / 45 (6.67%)
    4 / 55 (7.27%)
         occurrences all number
    3
    4
    Application site rash
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Injection site rash
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Injection site reaction
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Injection site urticaria
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Social circumstances
    Treatment noncompliance
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Breast haematoma
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Breast mass
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Menstruation irregular
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 45 (4.44%)
    1 / 55 (1.82%)
         occurrences all number
    2
    1
    Insomnia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    2 / 45 (4.44%)
    6 / 55 (10.91%)
         occurrences all number
    2
    6
    Amylase increased
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Blood glucose increased
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Weight increased
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Incision site pain
         subjects affected / exposed
    5 / 45 (11.11%)
    4 / 55 (7.27%)
         occurrences all number
    5
    4
    Wound dehiscence
         subjects affected / exposed
    4 / 45 (8.89%)
    0 / 55 (0.00%)
         occurrences all number
    4
    0
    Incision site pruritus
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Procedural site reaction
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Ankle fracture
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Burns second degree
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Incision site complication
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Post procedural swelling
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Procedural headache
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Procedural nausea
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Procedural vomiting
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Spinal compression fracture
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Suture rupture
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Paraesthesia
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Hyperaesthesia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Piriformis syndrome
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Motion sickness
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 45 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    0
    4
    Constipation
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Gingival pain
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Scar pain
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Itching scar
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Acne
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 45 (4.44%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Pain in jaw
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
    2 / 55 (3.64%)
         occurrences all number
    1
    2
    Influenza
         subjects affected / exposed
    0 / 45 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 45 (2.22%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Bronchitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Fungal infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Vaginal infection
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Viral rhinitis
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Folate deficiency
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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