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    Clinical Trial Results:
    A 16 Week, Single-Center, Randomized, Placebo- and Active-Controlled Proof-of-Principle Study to Assess the Efficacy and Safety of a 5% Minoxidil Topical Gel Formulation in Male Subjects with Androgenetic Alopecia

    Summary
    EudraCT number
    		 2017-000613-22
    Trial protocol
    		 DE  
    Global end of trial date
    05 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Dec 2020
    First version publication date
    20 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CO-150225133959
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Johnson & Johnson Consumer Inc
    Sponsor organisation address
    199 Grandview Road, Skillman, United States, 08558
    Public contact
    Global Regulatory Affairs, Johnson & Johnson Consumer Inc , 215 4297845,
    Scientific contact
    Global Regulatory Affairs, Johnson & Johnson Consumer Inc , 215 4297845,
    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
    05 Dec 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of study was to determine the efficacy of two formulations of minoxidil, 5 percent (%) Minoxidil Topical Gel (5% MTG) and 5% Minoxidil Topical Foam (5% MTF), for hereditary hair loss in men.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices (GCP) and applicable regulatory requirements. Safety was evaluated by examining the incidence and type of adverse events, changes in clinical laboratory tests and vital signs.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jan 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 140
    Worldwide total number of subjects
    140
    EEA total number of subjects
    140
    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)
    140
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total of 148 subjects were screened and 140 subjects were randomized to receive one of the five study treatments.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]
    Blinding implementation details
    Investigators were kept blinded during the study. Subjects that received gel did not know if they were on placebo or active. But subjects that received foam know they were on active.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 5% Minoxidil Topical Gel (MTG) Once Daily (OD)
    Arm description
    		 Subjects received 5 percent (%) MTG once daily until Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Minoxidil Topical Gel (MTG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received 5 percent (%) MTG once daily until Week 16.

    Arm title
    		 Placebo Topical Gel (PTG) OD
    Arm description
    		 Subjects received matching PTG once daily until Week 16.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo Topical Gel (PTG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received matching PTG once daily until Week 16.

    Arm title
    		 5% MTG Twice a Day (BID)
    Arm description
    		 Subjects received 5 % MTG twice daily until Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    5% MTG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received 5% MTG twice daily until Week 16.

    Arm title
    		 PTG BID
    Arm description
    		 Subjects received matching PTG twice daily until Week 16.
    Arm type
    		 Placebo

    Investigational medicinal product name
    PTG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received matching PTG twice daily until Week 16.

    Arm title
    		 5% Minoxidil Topical Foam (MTF) BID
    Arm description
    		 Subjects received 5 percent (%) MTF twice daily until Week 16.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    5% MTF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received 5 percent (%) MTF twice daily until Week 16.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: Investigators were kept blinded during the study. Subjects that received gel did not know if they were on placebo or active. But subjects that received foam know they were on active.
    Number of subjects in period 1
    		5% Minoxidil Topical Gel (MTG) Once Daily (OD) Placebo Topical Gel (PTG) OD 5% MTG Twice a Day (BID) PTG BID 5% Minoxidil Topical Foam (MTF) BID
    Started
    41
    20
    39
    20
    20
    Completed
    41
    20
    38
    18
    19
    Not completed
    0
    0
    1
    2
    1
         Consent withdrawn by subject
    -
    -
    1
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    5% Minoxidil Topical Gel (MTG) Once Daily (OD)
    Reporting group description
    		 Subjects received 5 percent (%) MTG once daily until Week 16.

    Reporting group title
    Placebo Topical Gel (PTG) OD
    Reporting group description
    		 Subjects received matching PTG once daily until Week 16.

    Reporting group title
    5% MTG Twice a Day (BID)
    Reporting group description
    		 Subjects received 5 % MTG twice daily until Week 16.

    Reporting group title
    PTG BID
    Reporting group description
    		 Subjects received matching PTG twice daily until Week 16.

    Reporting group title
    5% Minoxidil Topical Foam (MTF) BID
    Reporting group description
    		 Subjects received 5 percent (%) MTF twice daily until Week 16.

    Reporting group values
    		 5% Minoxidil Topical Gel (MTG) Once Daily (OD) Placebo Topical Gel (PTG) OD 5% MTG Twice a Day (BID) PTG BID 5% Minoxidil Topical Foam (MTF) BID Total
    Number of subjects
    		 41 20 39 20 20 140
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 41 20 39 20 20 140
        From 65 to 84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.1 ± 7.69 35.2 ± 6.59 33.3 ± 7.82 32.2 ± 8.36 32.7 ± 5.81 -
    Title for Gender
    Units: subjects
        Male
    		 41 20 39 20 20 140

    End points

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    End points reporting groups
    Reporting group title
    5% Minoxidil Topical Gel (MTG) Once Daily (OD)
    Reporting group description
    		 Subjects received 5 percent (%) MTG once daily until Week 16.

    Reporting group title
    Placebo Topical Gel (PTG) OD
    Reporting group description
    		 Subjects received matching PTG once daily until Week 16.

    Reporting group title
    5% MTG Twice a Day (BID)
    Reporting group description
    		 Subjects received 5 % MTG twice daily until Week 16.

    Reporting group title
    PTG BID
    Reporting group description
    		 Subjects received matching PTG twice daily until Week 16.

    Reporting group title
    5% Minoxidil Topical Foam (MTF) BID
    Reporting group description
    		 Subjects received 5 percent (%) MTF twice daily until Week 16.

    Primary: Change from Baseline in Total Non-vellus Target Area Hair Count (TAHC) at Week 16

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    End point title
    		 Change from Baseline in Total Non-vellus Target Area Hair Count (TAHC) at Week 16
    End point description
    TAHC was measured by computerized Hair MetrixSM system based on macrophotographs at Week 16. Intent-to-treat (ITT) population included all randomized subjects. Here, ‘N’ (number of subjects analyzed) signifies those subjects who were evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 5% Minoxidil Topical Gel (MTG) Once Daily (OD) Placebo Topical Gel (PTG) OD 5% MTG Twice a Day (BID) PTG BID 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects analysed
    41
    20
    37
    20
    19
    Units: Units on a scale
        arithmetic mean (standard deviation)
    29.0 ± 23.06
    8.1 ± 16.08
    43.4 ± 24.83
    0 ± 26.00
    42.3 ± 40.10
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -20.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -34.59
         upper limit
    		 -6.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.138
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    5% MTG Twice a Day (BID) v 5% Minoxidil Topical Gel (MTG) Once Daily (OD)
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    14.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.64
         upper limit
    		 25.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.869
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.092
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    12.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.02
         upper limit
    		 26.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.218
    Statistical analysis title
    		 Statistical Analysis 4
    Comparison groups
    5% MTG Twice a Day (BID) v PTG BID
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -44.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -58.78
         upper limit
    		 -30.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.203
    Statistical analysis title
    		 Statistical Analysis 5
    Comparison groups
    5% MTG Twice a Day (BID) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.788
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.58
         upper limit
    		 12.59

    Secondary: Change from Baseline in Total Non-vellus TAHC at Weeks 8 and 12

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    End point title
    		 Change from Baseline in Total Non-vellus TAHC at Weeks 8 and 12
    End point description
    TAHC was measured by computerized Hair MetrixSM system based on macrophotographs at Weeks 8 and 12. ITT population included all randomized subjects. Here 'n' signifies number of subjects analyzed for specific arm.
    End point type
    Secondary
    End point timeframe
    Weeks 8 and 12
    End point values
    		 5% Minoxidil Topical Gel (MTG) Once Daily (OD) Placebo Topical Gel (PTG) OD 5% MTG Twice a Day (BID) PTG BID 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects analysed
    41
    20
    39
    20
    20
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 8 (n=40, 20, 38, 18, 18))
    6.9 ± 20.58
    5.9 ± 14.07
    22.0 ± 23.78
    -4.8 ± 21.16
    24.8 ± 25.33
        Week 12 (n=41, 20, 38, 18, 18)
    21.8 ± 26.56
    6.3 ± 18.33
    39.2 ± 28.13
    -3.9 ± 22.17
    41.1 ± 30.66
    Statistical analysis title
    		 Statistical Analysis 1 (Week 8)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.919
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.48
         upper limit
    		 11.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    6
    Statistical analysis title
    		 Statistical Analysis 2 (Week 8)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    14.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.14
         upper limit
    		 24.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.906
    Statistical analysis title
    		 Statistical Analysis 3 (Week 8)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    17.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.57
         upper limit
    		 30.09
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.194
    Statistical analysis title
    		 Statistical Analysis 4 (Week 8)
    Comparison groups
    5% MTG Twice a Day (BID) v PTG BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -26.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.06
         upper limit
    		 -14.54
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.195
    Statistical analysis title
    		 Statistical Analysis 5 (Week 8)
    Comparison groups
    5% Minoxidil Topical Foam (MTF) BID v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.635
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.42
         upper limit
    		 15.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.262
    Statistical analysis title
    		 Statistical Analysis 6 (Week 12)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.034
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -15.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29.23
         upper limit
    		 -1.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.091
    Statistical analysis title
    		 Statistical Analysis 7 (Week 12)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    16.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.47
         upper limit
    		 28.37
    Variability estimate
    Standard error of the mean
    Dispersion value
    5.787
    Statistical analysis title
    		 Statistical Analysis 8 (Week 12)
    Comparison groups
    5% Minoxidil Topical Foam (MTF) BID v 5% Minoxidil Topical Gel (MTG) Once Daily (OD)
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    18.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.67
         upper limit
    		 32.63
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.32
    Statistical analysis title
    		 Statistical Analysis 9 (Week 12)
    Comparison groups
    PTG BID v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -43.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -58.21
         upper limit
    		 -29.12
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.352
    Statistical analysis title
    		 Statistical Analysis 10 (Week 12)
    Comparison groups
    5% Minoxidil Topical Foam (MTF) BID v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.868
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.47
         upper limit
    		 15.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.431

    Secondary: Change from Baseline in Non-vellus Target Area Hair Width (TAHW) at Weeks 8, 12 and 16

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    End point title
    		 Change from Baseline in Non-vellus Target Area Hair Width (TAHW) at Weeks 8, 12 and 16
    End point description
    TAHW was measured by computerized Hair MetrixSM system based on macrophotographs at Weeks 8, 12, and 16. ITT population included all randomized subjects. Here 'n' signifies number of subjects analyzed for specific arm.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 12 and 16
    End point values
    		 5% Minoxidil Topical Gel (MTG) Once Daily (OD) Placebo Topical Gel (PTG) OD 5% MTG Twice a Day (BID) PTG BID 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects analysed
    41
    20
    39
    20
    20
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 8 (n=40, 20, 38, 18, 18)
    267.87 ± 1123.266
    225.98 ± 601.592
    1148.05 ± 1203.968
    -248.32 ± 1057.438
    1024.53 ± 1340.988
        Week 12 (n=41, 20, 38, 18, 18)
    10877.12 ± 4528.346
    7992.00 ± 3978.613
    12054.63 ± 4335.559
    9623.74 ± 3166.357
    10216.52 ± 4164.070
        Week 16 (n=40, 20, 37, 20, 19)
    1561.46 ± 1492.961
    190.30 ± 755.771
    2301.72 ± 1526.758
    -143.80 ± 1308.662
    2074.94 ± 2301.889
    Statistical analysis title
    		 Statistical analysis 1 (Week 8)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.96
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    15.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -591.006
         upper limit
    		 621.426
    Variability estimate
    Standard error of the mean
    Dispersion value
    306.353
    Statistical analysis title
    		 Statistical analysis 2 (Week 8)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    858.748
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 362.76
         upper limit
    		 1354.736
    Variability estimate
    Standard error of the mean
    Dispersion value
    250.648
    Statistical analysis title
    		 Statistical analysis 3 (Week 8)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.017
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    763.563
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 136.567
         upper limit
    		 1390.558
    Variability estimate
    Standard error of the mean
    Dispersion value
    316.853
    Statistical analysis title
    		 Statistical analysis 4 (Week 8)
    Comparison groups
    PTG BID v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1408.135
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2034.106
         upper limit
    		 -782.164
    Variability estimate
    Standard error of the mean
    Dispersion value
    316.335
    Statistical analysis title
    		 Statistical analysis 5 (Week 8)
    Comparison groups
    5% MTG Twice a Day (BID) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.766
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -95.185
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -727.523
         upper limit
    		 537.153
    Variability estimate
    Standard error of the mean
    Dispersion value
    319.553
    Statistical analysis title
    		 Statistical analysis 6 (Week 12)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.026
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -963.866
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1807.75
         upper limit
    		 -119.982
    Variability estimate
    Standard error of the mean
    Dispersion value
    426.49
    Statistical analysis title
    		 Statistical analysis 7 (Week 12)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    907.493
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 218.819
         upper limit
    		 1596.167
    Variability estimate
    Standard error of the mean
    Dispersion value
    348.049
    Statistical analysis title
    		 Statistical analysis 8 (Week 12)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.102
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    725.437
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -147.175
         upper limit
    		 1598.049
    Variability estimate
    Standard error of the mean
    Dispersion value
    441.009
    Statistical analysis title
    		 Statistical analysis 9 (Week 12)
    Comparison groups
    5% MTG Twice a Day (BID) v PTG BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2514.894
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3389.491
         upper limit
    		 -1640.297
    Variability estimate
    Standard error of the mean
    Dispersion value
    442.013
    Statistical analysis title
    		 Statistical analysis 10 (Week 12)
    Comparison groups
    5% MTG Twice a Day (BID) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.684
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -182.056
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1065.551
         upper limit
    		 701.438
    Variability estimate
    Standard error of the mean
    Dispersion value
    446.509
    Statistical analysis title
    		 Statistical analysis 11 (Week 16)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1300.171
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2123.078
         upper limit
    		 -477.264
    Variability estimate
    Standard error of the mean
    Dispersion value
    415.95
    Statistical analysis title
    		 Statistical analysis 12 (Week 16)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.037
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    718.759
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 42.551
         upper limit
    		 1394.967
    Variability estimate
    Standard error of the mean
    Dispersion value
    341.799
    Statistical analysis title
    		 Statistical analysis 13 (Week 16)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.269
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    467.947
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -365.487
         upper limit
    		 1301.382
    Variability estimate
    Standard error of the mean
    Dispersion value
    421.271
    Statistical analysis title
    		 Statistical analysis 14 (Week 16)
    Comparison groups
    5% MTG Twice a Day (BID) v PTG BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -2512.224
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3341.403
         upper limit
    		 -1683.045
    Variability estimate
    Standard error of the mean
    Dispersion value
    419.12
    Statistical analysis title
    		 Statistical analysis 15 (Week 16)
    Comparison groups
    5% MTG Twice a Day (BID) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.56
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -250.812
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1099.746
         upper limit
    		 598.123
    Variability estimate
    Standard error of the mean
    Dispersion value
    429.106

    Secondary: Global Photographs Rating for Hair Loss Condition in the Vertex Region at Weeks 8, 12, and 16

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    End point title
    		 Global Photographs Rating for Hair Loss Condition in the Vertex Region at Weeks 8, 12, and 16
    End point description
    Subject rating via global photographs of hair loss condition in the vertex region was reported at Weeks 8, 12, and 16. Hair loss condition was measured by using a 7-point scale ranging from -3 to +3: where -3 indicated significantly worse and +3 means significantly improved. ITT population included all randomized subjects. Here 'N' signifies number of subjects who were evaluable for this endpoint. Here 'n' signifies number of subjects analyzed for specific arm.
    End point type
    Secondary
    End point timeframe
    Weeks 8, 12, and 16
    End point values
    		 5% Minoxidil Topical Gel (MTG) Once Daily (OD) Placebo Topical Gel (PTG) OD 5% MTG Twice a Day (BID) PTG BID 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects analysed
    41
    20
    39
    20
    20
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 8 (n=41, 20, 39, 18, 19)
    0.5 ± 0.87
    0.1 ± 0.76
    0.4 ± 0.99
    0.3 ± 1.13
    0.6 ± 0.90
        Week 12 (n=41, 20, 39, 18, 19)
    0.7 ± 1.02
    0.4 ± 0.88
    1.2 ± 1.11
    -0.2 ± 1.26
    1.3 ± 0.75
        Week 16 (n=41, 20, 38, 20, 20)
    1.0 ± 1.08
    0.3 ± 0.73
    1.1 ± 1.17
    0.1 ± 1.02
    1.4 ± 0.75
    Statistical analysis title
    		 Statistical analysis 1 (Week 8)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.093
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.94
         upper limit
    		 0.07
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 Statistical analysis 2 (Week 8)
    Comparison groups
    5% MTG Twice a Day (BID) v 5% Minoxidil Topical Gel (MTG) Once Daily (OD)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.611
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.52
         upper limit
    		 0.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.21
    Statistical analysis title
    		 Statistical analysis 3 (Week 8)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.743
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 Statistical analysis 4 (Week 8)
    Comparison groups
    5% MTG Twice a Day (BID) v PTG BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.683
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.64
         upper limit
    		 0.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.27
    Statistical analysis title
    		 Statistical analysis 5 (Week 8)
    Comparison groups
    5% MTG Twice a Day (BID) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.464
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.33
         upper limit
    		 0.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 Statistical analysis 6 (Week 12)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.286
    Method
    		 ANCOVA
    Parameter type
    		 Analysis of covariance
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.86
         upper limit
    		 0.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Statistical analysis 7 (Week 12)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.036
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.03
         upper limit
    		 0.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Statistical analysis title
    		 Statistical analysis 8 (Week 12)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.08
         upper limit
    		 1.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Statistical analysis 9 (Week 12)
    Comparison groups
    5% MTG Twice a Day (BID) v PTG BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.96
         upper limit
    		 -0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Statistical analysis 10 (Week 12)
    Comparison groups
    5% MTG Twice a Day (BID) v 5% Minoxidil Topical Foam (MTF) BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.582
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.41
         upper limit
    		 0.73
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Statistical analysis title
    		 Statistical analysis 11 (Week 16)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v Placebo Topical Gel (PTG) OD
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.019
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 -0.11
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Statistical analysis 12 (Week 16)
    Comparison groups
    5% Minoxidil Topical Gel (MTG) Once Daily (OD) v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.681
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.36
         upper limit
    		 0.54
    Statistical analysis title
    		 Statistical analysis 13 (Week 16)
    Comparison groups
    5% Minoxidil Topical Foam (MTF) BID v 5% Minoxidil Topical Gel (MTG) Once Daily (OD)
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.154
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.15
         upper limit
    		 0.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Statistical analysis 14 (Week 16)
    Comparison groups
    5% MTG Twice a Day (BID) v PTG BID
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.56
         upper limit
    		 -0.46
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28
    Statistical analysis title
    		 Statistical analysis 15 (Week 16)
    Comparison groups
    5% Minoxidil Topical Foam (MTF) BID v 5% MTG Twice a Day (BID)
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.281
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.25
         upper limit
    		 0.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.28

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 1 year
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    5% MTG(OD)
    Reporting group description
    		 5% Minoxidil Topical Gel (F13496-121) OD

    Reporting group title
    PTG(OD)
    Reporting group description
    		 Placebo Topical Gel (F13496-123) OD

    Reporting group title
    5% MTG(BID)
    Reporting group description
    		 5% Minoxidil Topical Gel (F13496-121) BID

    Reporting group title
    PTG(BID)
    Reporting group description
    		 Placebo Topical Gel (F13496-123) BID

    Reporting group title
    5% MTF(BID)
    Reporting group description
    		 5% Minoxidil Topical Foam (FDS-W016140-0002) BID

    Serious adverse events
    		 5% MTG(OD) PTG(OD) 5% MTG(BID) PTG(BID) 5% MTF(BID)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 5% MTG(OD) PTG(OD) 5% MTG(BID) PTG(BID) 5% MTF(BID)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 41 (60.98%)
    14 / 20 (70.00%)
    18 / 39 (46.15%)
    13 / 20 (65.00%)
    12 / 20 (60.00%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Exposure to Communicable Disease
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Ligament Rupture
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Ligament Sprain
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rib Fracture
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Scratch
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Sunburn
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    8 / 41 (19.51%)
    6 / 20 (30.00%)
    3 / 39 (7.69%)
    3 / 20 (15.00%)
    5 / 20 (25.00%)
         occurrences all number
    12
    8
    6
    3
    13
    General disorders and administration site conditions
    Application Site Pain
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Application Site Pruritus
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Influenza Like Illness
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    0
    1
    Food Poisoning
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    3
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    2 / 39 (5.13%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinitis Allergic
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    0
    1
    2
    Pruritus
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Seborrhoeic Dermatitis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    2 / 39 (5.13%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Psychiatric disorders
    Sleep Disorder
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 20 (5.00%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Musculoskeletal Stiffness
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    1 / 39 (2.56%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Infections and infestations
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    0
    0
    1
    Otitis Media
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    1 / 39 (2.56%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    2 / 39 (5.13%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Subcutaneous Abscess
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 20 (5.00%)
    0 / 39 (0.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 20 (0.00%)
    0 / 39 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    14 / 41 (34.15%)
    6 / 20 (30.00%)
    10 / 39 (25.64%)
    6 / 20 (30.00%)
    6 / 20 (30.00%)
         occurrences all number
    17
    7
    12
    6
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Oct 2018
    Protocol Amendment-2: Protocol has been revised after comments were received from Independent Ethics Committee (IEC) in addition to some clarification added from Johnson & Johnson.
    23 Nov 2018
    Protocol Amendment 3: Protocol has been revised with some added clarifications from Johnson & Johnson as some inconsistencies were noted.
    21 Mar 2019
    Protocol Amendment 4: Protocol has been revised with some added clarifications from Johnson & Johnson as some inconsistencies were noted.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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