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    Clinical Trial Results:
    A Phase 3 Randomized Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers (EU)

    Summary
    EudraCT number
    		 2012-003286-18
    Trial protocol
    		 HU   PL   DE   BE   CZ  
    Global end of trial date
    27 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Mar 2016
    First version publication date
    06 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    802-247-09-032
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01853384
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Smith & Nephew, Inc.
    Sponsor organisation address
    3909 Hulen Street, Fort Worth, Texas, United States, 76107
    Public contact
    Jaime Dickerson, PhD VP Global Medical and Clinical Affairs 3909 Hulen St Fort Worth, TX 76107 , Smith & Nephew, Inc., +1 8173023914,
    Scientific contact
    Jaime Dickerson, PhD VP Global Medical and Clinical Affairs 3909 Hulen St Fort Worth, TX 76107 , Smith & Nephew, Inc., +1 8173023914,
    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
    09 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Compare HP802-247 plus compression therapy against Control (Vehicle) plus compression therapy for the proportion of subjects with complete wound closure of venous leg ulcers over the 12-week treatment period from baseline.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. The rationale of the study, procedural details, and investigational goals were explained to each patient, along with potential risks and benefits. Each patient was assured of his/her right to withdraw from the study at any time. Prior to the initiation of any study procedures all subjects were provided the opportunity to ask questions. Subjects, or their legal representatives, read, signed, and dated the IEC-approved consent form before taking part in any study activity.
    Background therapy
    		 Four-layer compression therapy was used across all arms in the trial
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jan 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 2 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 108
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Czech Republic: 38
    Country: Number of subjects enrolled
    Germany: 49
    Country: Number of subjects enrolled
    Hungary: 52
    Worldwide total number of subjects
    252
    EEA total number of subjects
    252
    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)
    103
    From 65 to 84 years
    130
    85 years and over
    19

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A 2-weeks Screening and Run-in period was employed. Eligibility criteria were reviewed and qualified subjects providing informed consent began Screening Run-in Visit 1. Subjects were screened again for eligibility at the end of the Run-in period (Run-in Visit 3) against an additional set of exclusion criteria.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Data analyst, Carer, Assessor
    Blinding implementation details
    An IWRS was used for randomization. The IWRS used computer generated random sequences which took into account stratification by wound area and wound duration.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 HP802-247
    Arm description
    		 Treatment group who received HP802-247 formulation
    Arm type
    		 Experimental

    Investigational medicinal product name
    HP802-247
    Investigational medicinal product code
    HP802-247
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    HP802-247 formulation consists of two separate components, a fibrinogen solution and a cell suspension. A single dose is created when combined on the wound surface. 260 μL (130 μL, one spray, of each solution) containing 0.5x106 cells/mL is administered every 14 days and Vehicle on alternate weeks.

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    The vehicle formulation (260 μL (130 μL, one spray, of each solution) containing fibrinogen solution and thrombin solution without cells) is administered every 14 days, on the alternate weeks.

    Arm title
    		 Vehicle
    Arm description
    		 Treatment group who received vehicle formulation only
    Arm type
    		 Control

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous spray
    Routes of administration
    Topical use
    Dosage and administration details
    The vehicle formulation (260 μL (130 μL, one spray, of each solution) containing fibrinogen solution and thrombin solution without cells) is administered every 7 days

    Number of subjects in period 1
    		HP802-247 Vehicle
    Started
    131
    121
    Completed
    69
    75
    Not completed
    62
    46
         Consent withdrawn by subject
    5
    3
         Other
    3
    3
         Sponsor's request - Early Termination
    47
    34
         Adverse Events
    6
    5
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HP802-247
    Reporting group description
    		 Treatment group who received HP802-247 formulation

    Reporting group title
    Vehicle
    Reporting group description
    		 Treatment group who received vehicle formulation only

    Reporting group values
    		 HP802-247 Vehicle Total
    Number of subjects
    		 131 121 252
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 58 45 103
        From 65-84 years
    		 65 65 130
        85 years and over
    		 8 11 19
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.6 ( 13.1 ) 68.1 ( 12.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 76 63 139
        Male
    		 55 58 113

    End points

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    End points reporting groups
    Reporting group title
    HP802-247
    Reporting group description
    		 Treatment group who received HP802-247 formulation

    Reporting group title
    Vehicle
    Reporting group description
    		 Treatment group who received vehicle formulation only

    Primary: The average proportion (%) of wounds closed from baseline to completion of the 12-week treatment period

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    End point title
    		 The average proportion (%) of wounds closed from baseline to completion of the 12-week treatment period
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to week 12
    End point values
    		 HP802-247 Vehicle
    Number of subjects analysed
    131
    121
    Units: percentage of wound
    number (not applicable)
        Wound closed
    46.6
    50.4
        Wound not closed
    53.4
    49.6
    Statistical analysis title
    		 Average proportion of closed wounds
    Statistical analysis description
    Compare the Treatment Groups for the Average Proportion of Subjects With complete Wound Closure over the 12-week Treatment Period from Baseline
    Comparison groups
    HP802-247 v Vehicle
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5348
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Time in days to complete wound closure from baseline over the 12 double-blind treatment weeks

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    End point title
    		 Time in days to complete wound closure from baseline over the 12 double-blind treatment weeks
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to wound closure
    End point values
    		 HP802-247 Vehicle
    Number of subjects analysed
    131
    121
    Units: days
        arithmetic mean (standard deviation)
    50.3 ( 27.6 )
    52.6 ( 27.4 )
    Statistical analysis title
    		 Efficacy Comparison, based on Median Time (days)
    Statistical analysis description
    Compare the Efficacy of the treatment groups in achieving complete wound closure, based on median time (days) to closure over the 12-week treatment period from baseline
    Comparison groups
    HP802-247 v Vehicle
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.9456
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.988
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.692
         upper limit
    		 1.41
    Notes
    [1] - Cox Regression Model
    Statistical analysis title
    		 Efficacy Comparison, based on Median Time (days)
    Statistical analysis description
    Compare the efficacy of the treatment groups in achieving complete wound closure, based on median time (days) to closure over the 12-week treatment period from baseline
    Comparison groups
    HP802-247 v Vehicle
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 > 0.5
    Method
    		 Logrank
    Confidence interval
    Notes
    [2] - Kaplan-Meier Survival

    Secondary: Proportion of Subjects with Complete Ulcer Closure at Each of the 12 Treatment Weeks from Baseline

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    End point title
    		 Proportion of Subjects with Complete Ulcer Closure at Each of the 12 Treatment Weeks from Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to each of the 12 Treatment Weeks
    End point values
    		 HP802-247 Vehicle
    Number of subjects analysed
    131
    121
    Units: Percentage of Closure
    number (not applicable)
        Baseline
    0
    0
        Treatment Week 01
    2.3
    3.3
        Treatment Week 02
    8.4
    7.4
        Treatment Week 03
    13.7
    18.2
        Treatment Week 04
    22.1
    25.6
        Treatment Week 05
    26.7
    33.9
        Treatment Week 06
    29.8
    38
        Treatment Week 07
    32.8
    39.7
        Treatment Week 08
    37.4
    39.7
        Treatment Week 09
    38.9
    43.8
        Treatment Week 10
    40.5
    46.3
        Treatment Week 11
    41.2
    47.9
        Treatment Week 12
    48.1
    53.7
    Statistical analysis title
    		 Comparison of Wound closure at each week
    Statistical analysis description
    Compare the treatment groups for the proportion of subjects with wound closure at each of the 12-week treatment period from baseline
    Comparison groups
    HP802-247 v Vehicle
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3722 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - Week 1: p=0.6194 Week 2: p=0.7930 Week 3: P=0.3362 Week 4: p= 0.5263 Week 5: p=0.1997 Week 6: P=0.1617 Week 7: p=0.2611 Week 8: p=0.7232 Week 9: P=0.4405 Week 10: p=0.3516 Week 11: p=0.2821 Week 12: P=0.3722

    Secondary: Pain associated with target wound at each of the 12 double blind treatment weeks

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    End point title
    		 Pain associated with target wound at each of the 12 double blind treatment weeks
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to each of the 12 double blind treatment weeks
    End point values
    		 HP802-247 Vehicle
    Number of subjects analysed
    131
    121
    Units: Mean Change (in mm) in VAS Pain Score
    number (not applicable)
        Baseline
    29.4
    26.3
        Treatment Week 01
    -8.6
    -7.5
        Treatment week 02
    -10.4
    -11
        Treatment week 03
    -14
    -10.7
        Treatment week 04
    -14.3
    -12.1
        Treatment week 05
    -17.2
    -13.6
        Treatment week 06
    -17.8
    -15.4
        Treatment week 07
    -18.5
    -17.5
        Treatment week 08
    -20
    -17.1
        Treatment week 09
    -19.7
    -17.9
        Treatment week 10
    -18.9
    -18.4
        Treatment week 11
    -19.4
    -19.7
        Treatment week 12
    -20
    -20.1
    Statistical analysis title
    		 Pain associated with target wound
    Statistical analysis description
    Pain associated with the target wound at each of the 12 double blind treatment weeks, based on a VAS (Range 0-100mm; , 0 denoting no pain and 100mm the maximum pain)
    Comparison groups
    HP802-247 v Vehicle
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9733 [4]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.958
         upper limit
    		 4.095
    Notes
    [4] - Week 1: p=0.5909 Week 2: p=0.8234 Week 3: P=0.1556 Week 4: p=0.3487 Week 5: p=0.1064 Week 6: p= 0.2888 Week 7: p=0.6095 Week 8: P=0.1566 Week 9: p=0.4216 Week 10: p= 0.8166 Week 11: p= 0.9114 Week 12: P=0.9733

    Secondary: Pain associated with target leg at each of the 12 double blind treatment weeks

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    End point title
    		 Pain associated with target leg at each of the 12 double blind treatment weeks
    End point description
    End point type
    Secondary
    End point timeframe
    From Baseline to each of the 12 double blind treatment weeks
    End point values
    		 HP802-247 Vehicle
    Number of subjects analysed
    131
    121
    Units: Mean Change (in mm) in VAS Pain Score
    number (not applicable)
        Baseline
    24.18
    22.35
        Treatment week 01
    -4.1
    -4.9
        Treatment week 02
    -2.2
    -1.3
        Treatment week 03
    -9.2
    -5.3
        Treatment week 04
    -10.1
    -8.8
        Treatment week 05
    -9.7
    -8.6
        Treatment week 06
    -12.2
    -9.1
        Treatment week 07
    -13.1
    -8.9
        Treatment week 08
    -14.2
    -9
        Treatment week 09
    -10.1
    -6.3
        Treatment week 10
    -12.7
    -11.1
        Treatment week 11
    -12.9
    -11.8
        Treatment week 12
    -14.3
    -12.2
    Statistical analysis title
    		 Pain with Target Leg
    Statistical analysis description
    Pain associated with the target leg at each of the 12 double blind treatment weeks, base on a VAS (range 0-100mm; 0 denoting no pain and 100mm the maximum pain)
    Comparison groups
    HP802-247 v Vehicle
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3369 [5]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.218
         upper limit
    		 2.137
    Notes
    [5] - Week 1: p= 0.7439 Week 2: p=0.6992 Week 3: P=0.0867 Week 4: p=0.5739 Week 5: p=0.6497 Week 6: p=0.1427 Week 7: p=0.0682 Week 8: P=0.0161 Week 9: p=0.0973 Week 10: p=0.4661 Week 11: p=0.6010 Week 12: P=0.3369

    Secondary: Proportion of subjects with durable wound healing over the 3 months following complete wound closure

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    End point title
    		 Proportion of subjects with durable wound healing over the 3 months following complete wound closure
    End point description
    End point type
    Secondary
    End point timeframe
    at 3 months after complete wound healing
    End point values
    		 HP802-247 Vehicle
    Number of subjects analysed
    57
    57
    Units: Number of subjects
    number (not applicable)
        Wound remained closed
    51
    47
        Wound re-opened
    6
    10
    Statistical analysis title
    		 Durable wound healing over 3months after closure
    Statistical analysis description
    Proportion of subjects with durable wound healing over the 3 months following complete wound closure
    Comparison groups
    HP802-247 v Vehicle
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3258
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Other pre-specified: Response to the SPVU-5D, a condition specific preference-based measure of health-related quality of life for use in the assessment of the impact of venous ulceration

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    End point title
    		 Response to the SPVU-5D, a condition specific preference-based measure of health-related quality of life for use in the assessment of the impact of venous ulceration
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From Baseline to End of treatment
    End point values
    		 HP802-247 Vehicle
    Number of subjects analysed
    131
    121
    Units: Change in SPVU-5D Score
    least squares mean (standard error)
        Baseline Score
    9.34 ( 2.74 )
    8.69 ( 2.38 )
        Change from Baseline at Visit 12
    -1.28 ( 0.2 )
    -1.04 ( 0.21 )
    Statistical analysis title
    		 Quality of Life comparison
    Statistical analysis description
    Compare the quality of life between the treatments groups using change in the Sheffield Preference -based Venous Ulcer questionnaire (SPVU-5D) from baseline to the end of treatment
    Comparison groups
    HP802-247 v Vehicle
    Number of subjects included in analysis
    252
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2532
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.672
         upper limit
    		 0.178

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The evaluation of safety was conducted on all subjects randomized into the study and who received at least one dose of study drug and was assessed from the Screening/run-in period throughout the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    HP802-247
    Reporting group description
    		 -

    Reporting group title
    Vehicle
    Reporting group description
    		 -

    Serious adverse events
    		 HP802-247 Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 131 (3.82%)
    12 / 121 (9.92%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vulval cancer
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 131 (0.00%)
    2 / 121 (1.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Traumatic haematoma
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arrhythmia
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purpura
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Erysipelas
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 131 (0.76%)
    0 / 121 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    0 / 131 (0.00%)
    1 / 121 (0.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 HP802-247 Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    60 / 131 (45.80%)
    64 / 121 (52.89%)
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    10 / 131 (7.63%)
    6 / 121 (4.96%)
         occurrences all number
    12
    6
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 131 (3.82%)
    7 / 121 (5.79%)
         occurrences all number
    8
    8
    Nervous system disorders
    Nervous system disorder
         subjects affected / exposed
    2 / 131 (1.53%)
    4 / 121 (3.31%)
         occurrences all number
    7
    4
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed
    3 / 131 (2.29%)
    9 / 121 (7.44%)
         occurrences all number
    3
    11
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    5 / 131 (3.82%)
    6 / 121 (4.96%)
         occurrences all number
    9
    8
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    4 / 131 (3.05%)
    1 / 121 (0.83%)
         occurrences all number
    6
    2
    Erythema
         subjects affected / exposed
    4 / 131 (3.05%)
    5 / 121 (4.13%)
         occurrences all number
    4
    6
    Skin maceration
         subjects affected / exposed
    2 / 131 (1.53%)
    7 / 121 (5.79%)
         occurrences all number
    3
    13
    Skin ulcer
         subjects affected / exposed
    17 / 131 (12.98%)
    20 / 121 (16.53%)
         occurrences all number
    34
    37
    Venous ulcer pain
         subjects affected / exposed
    6 / 131 (4.58%)
    3 / 121 (2.48%)
         occurrences all number
    6
    3
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    5 / 131 (3.82%)
    12 / 121 (9.92%)
         occurrences all number
    6
    15
    Infections and infestations
    Infected skin ulcer
         subjects affected / exposed
    7 / 131 (5.34%)
    5 / 121 (4.13%)
         occurrences all number
    9
    7
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed
    2 / 131 (1.53%)
    4 / 121 (3.31%)
         occurrences all number
    2
    4

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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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