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    Clinical Trial Results:
    A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults with Scalp and Body Psoriasis

    Summary
    EudraCT number
    		 2019-003354-92
    Trial protocol
    		 BG  
    Global end of trial date
    25 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Oct 2023
    First version publication date
    19 Oct 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARQ-154-204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04128007
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 142047
    Sponsors
    Sponsor organisation name
    Arcutis Biotherapeutics, Inc.
    Sponsor organisation address
    3027 Townsgate Road, Suite 300, Westlake Village, CA , United States, 91361
    Public contact
    Clinical Trial Information , Arcutis Biotherapeutics, Inc., +1 805418 5006, information@arcutis.com
    Scientific contact
    Clinical Trial Information , Arcutis Biotherapeutics, Inc., +1 805418 5006, information@arcutis.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
    25 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Sep 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study assessed the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis
    Protection of trial subjects
    The study was performed in accordance with ICH GCP and the currently valid Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jan 2020
    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
    Australia: 9
    Country: Number of subjects enrolled
    Bulgaria: 24
    Country: Number of subjects enrolled
    Canada: 62
    Country: Number of subjects enrolled
    United States: 209
    Worldwide total number of subjects
    304
    EEA total number of subjects
    24
    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)
    2
    Adults (18-64 years)
    302
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adolescents and adults with plaque psoriasis were enrolled at 46 sites in North America, Australia, and Europe.

    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
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Roflumilast Foam 0.3%
    Arm description
    		 Participants applied roflumilast foam 0.3% once daily (QD) for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Roflumilast Foam 0.3%
    Investigational medicinal product code
    Other name
    ARQ-154
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical
    Dosage and administration details
    Roflumilast foam 0.3% applied topically QD for 8 weeks.

    Arm title
    		 Vehicle Foam
    Arm description
    		 Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle Foam
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous foam
    Routes of administration
    Topical
    Dosage and administration details
    Vehicle foam matched to roflumilast.

    Number of subjects in period 1
    		Roflumilast Foam 0.3% Vehicle Foam
    Started
    200
    104
    Completed
    177
    87
    Not completed
    23
    17
         Consent withdrawn by subject
    9
    6
         Adverse event, non-fatal
    5
    2
         Not reported
    -
    2
         Lost to follow-up
    8
    7
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Roflumilast Foam 0.3%
    Reporting group description
    		 Participants applied roflumilast foam 0.3% once daily (QD) for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.

    Reporting group title
    Vehicle Foam
    Reporting group description
    		 Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.

    Reporting group values
    		 Roflumilast Foam 0.3% Vehicle Foam Total
    Number of subjects
    		 200 104 304
    Age categorical
    Units: Subjects
        12-17 years
    		 1 1 2
        ≥18 years
    		 199 103 302
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.2 ± 14.22 45.0 ± 15.76 -
    Gender categorical
    Units: Subjects
        Female
    		 96 47 143
        Male
    		 104 57 161
    Race
    Units: Subjects
        Asian
    		 7 4 11
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 9 6 15
        White
    		 180 91 271
        More than one race
    		 1 1 2
        Unknown or Not Reported
    		 3 1 4
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 38 25 63
        Not Hispanic or Latino
    		 161 79 240
        Unknown or Not Reporte
    		 1 0 1
    Scalp Investigator Global Assessment (S-IGA) Baseline Score
    The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. Two participants in the Roflumilast Foam 0.3% arm did not have baseline S-IGA assessments (n=198).
    Units: Subjects
        0 - Clear
    		 0 0 0
        1 - Almost Clear
    		 0 0 0
        2 - Mild
    		 18 14 32
        3 - Moderate
    		 151 80 231
        4 - Severe
    		 29 10 39
        Not Recorded
    		 2 0 2
    Body Investigator Global Assessment (B-IGA) Baseline Score
    The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. Two participants in the Roflumilast Foam 0.3% arm did not have baseline B-IGA assessments (n=198).
    Units: Subjects
        0 - Clear
    		 0 0 0
        1 - Almost Clear
    		 0 0 0
        2 - Mild
    		 69 39 108
        3 - Moderate
    		 119 60 179
        4 - Severe
    		 10 5 15
        Not Recorded
    		 2 0 2
    Psoriasis Scalp Severity Index (PSSI) Baseline Score
    The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Two participants did not have a baseline PSSI assessment.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 22.4 ± 12.52 20.9 ± 11.70 -
    Scalp Itch Numeric Rating Scale (SI-NRS) Baseline Score
    The SI-NRS is a simple, single item scale to assess the participant-reported severity of scalp itch, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the past 24 hours. Higher scores indicate greater symptom severity.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 6.4 ± 2.35 6.6 ± 2.25 -
    Psoriasis Symptom Diary (PSD) Total Baseline Score
    The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. Two participants in the Roflumilast Foam 0.3% arm did not have baseline PSD assessments.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 78.5 ± 39.92 84.3 ± 38.76 -

    End points

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    End points reporting groups
    Reporting group title
    Roflumilast Foam 0.3%
    Reporting group description
    		 Participants applied roflumilast foam 0.3% once daily (QD) for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.

    Reporting group title
    Vehicle Foam
    Reporting group description
    		 Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.

    Primary: Achievement of Success in the Scalp Investigator Global Assessment (S-IGA) Scale

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    End point title
    		 Achievement of Success in the Scalp Investigator Global Assessment (S-IGA) Scale
    End point description
    Achievement of success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. All randomized participants with S-IGA score at baseline ≥2 and data available are included.
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 Roflumilast Foam 0.3% Vehicle Foam
    Number of subjects analysed
    181
    88
    Units: Participants
    107
    10
    Statistical analysis title
    		 S-IGA Success at Week 8 Odds Ratio
    Comparison groups
    Roflumilast Foam 0.3% v Vehicle Foam
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    14.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.64
         upper limit
    		 32.32
    Notes
    [1] - Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.

    Primary: Achievement of PSSI-90

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    End point title
    		 Achievement of PSSI-90
    End point description
    Achievement of a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only. All randomized participants with data available are included.
    End point type
    Primary
    End point timeframe
    Week 8
    End point values
    		 Roflumilast Foam 0.3% Vehicle Foam
    Number of subjects analysed
    180
    87
    Units: Participants
    84
    3
    Statistical analysis title
    		 PSSI-90 at Week 8 Odds Ratio
    Comparison groups
    Roflumilast Foam 0.3% v Vehicle Foam
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    34.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.49
         upper limit
    		 139.77
    Notes
    [2] - Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.

    Secondary: Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8

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    End point title
    		 Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8
    End point description
    Achievement of success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity. All randomized participants with data available and baseline B-IGA score ≥2 are included.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Roflumilast Foam 0.3% Vehicle Foam
    Number of subjects analysed
    181
    88
    Units: Participants
    73
    6
    Statistical analysis title
    		 B-IGA Success at Week 8 Odds Ratio
    Comparison groups
    Roflumilast Foam 0.3% v Vehicle Foam
    Number of subjects included in analysis
    269
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    8.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.65
         upper limit
    		 21.18
    Notes
    [3] - Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.

    Secondary: Achievement of Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score

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    End point title
    		 Achievement of Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
    End point description
    Achievement of SI-NRS success in participants with a baseline SI-NRS score ≥4 who achieve a ≥4-point improvement from Baseline at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only. All randomized participants with baseline SI-NRS score ≥4 with data available are included.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 2, 4, 8
    End point values
    		 Roflumilast Foam 0.3% Vehicle Foam
    Number of subjects analysed
    166
    90
    Units: Percentage of Participants
    number (not applicable)
        Week 2
    44.5
    15.6
        Week 4
    62.0
    22.31
        Week 8
    71.0
    18.5
    Statistical analysis title
    		 SI-NRS Success at Week 2 Odds Ratio
    Comparison groups
    Roflumilast Foam 0.3% v Vehicle Foam
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.14
         upper limit
    		 7.71
    Notes
    [4] - Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.
    Statistical analysis title
    		 SI-NRS Success at Week 4 Odds Ratio
    Comparison groups
    Roflumilast Foam 0.3% v Vehicle Foam
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    5.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.93
         upper limit
    		 9.78
    Notes
    [5] - Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.
    Statistical analysis title
    		 SI-NRS Success at Week 8 Odds Ratio
    Comparison groups
    Vehicle Foam v Roflumilast Foam 0.3%
    Number of subjects included in analysis
    256
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    9.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.02
         upper limit
    		 18.89
    Notes
    [6] - Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.

    Secondary: Change From Baseline in Psoriasis Symptoms Diary (PSD) Score

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    End point title
    		 Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
    End point description
    The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity. All randomized participants are included, with multiple imputation used for missing data.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 4 and 8
    End point values
    		 Roflumilast Foam 0.3% Vehicle Foam
    Number of subjects analysed
    200
    104
    Units: Score on a scale
    arithmetic mean (confidence interval 95%)
        Week 4
    -45.0 (-53.8 to -36.1)
    -25.4 (-35.2 to -15.6)
        Week 8
    -55.0 (-64.0 to -46.1)
    -27.5 (-37.5 to -17.6)
    Statistical analysis title
    		 Comparison of Week 4 PSD Change from Baseline
    Comparison groups
    Roflumilast Foam 0.3% v Vehicle Foam
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [7]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares (LS) Mean Difference
    Point estimate
    -19.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.4
         upper limit
    		 -11.8
    Notes
    [7] - ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.
    Statistical analysis title
    		 Comparison of Week 8 PSD Change from Baseline
    Comparison groups
    Vehicle Foam v Roflumilast Foam 0.3%
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -27.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.5
         upper limit
    		 -19.5
    Notes
    [8] - ANCOVA with country; treatment; and baseline S-IGA, B-IGA, and PSD scores as independent variables with multiple imputation of missing data.

    Secondary: Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score

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    End point title
    		 Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score
    End point description
    The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating greater symptom severity. All randomized participants are included. A value of '9999' indicates the number of cases is too low to calculate data.
    End point type
    Secondary
    End point timeframe
    Up to 8 weeks
    End point values
    		 Roflumilast Foam 0.3% Vehicle Foam
    Number of subjects analysed
    200
    104 [9]
    Units: Days
        median (confidence interval 95%)
    28.0 (17.0 to 29.0)
    9999 (67 to 9999)
    Notes
    [9] - 9999 denotes not calculable due to low number of cases.
    Statistical analysis title
    		 Time to PSSI-50 Hazard Ratio
    Comparison groups
    Roflumilast Foam 0.3% v Vehicle Foam
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [10]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    3.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.764
         upper limit
    		 5.616
    Notes
    [10] - Stratified by country, baseline S-IGA, and baseline B-IGA per randomization.

    Secondary: Achievement of Psoriasis Scalp Severity Index-75 (PSSI-75)

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    End point title
    		 Achievement of Psoriasis Scalp Severity Index-75 (PSSI-75)
    End point description
    Achievement of a 75% reduction in PSSI score (i.e., PSSI-75) from baseline is reported for each arm. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicate greater symptom severity. Results are based on observed data only. All randomized participants with data available are included.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    		 Roflumilast Foam 0.3% Vehicle Foam
    Number of subjects analysed
    180
    87
    Units: Participants
    121
    19
    Statistical analysis title
    		 PSSI-75 at Week 8 Odds Ratio
    Comparison groups
    Roflumilast Foam 0.3% v Vehicle Foam
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    9.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.81
         upper limit
    		 18.61
    Notes
    [11] - Stratified by country, baseline S-IGA, and baseline B-IGA per randomization with multiple imputation of missing data.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 9 weeks
    Adverse event reporting additional description
    All participants who received ≥1 dose of study intervention are included.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Roflumilast Foam 0.3%
    Reporting group description
    		 Participants applied roflumilast foam 0.3% once daily (QD) for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.

    Reporting group title
    Vehicle Foam
    Reporting group description
    		 Participants applied vehicle foam QD for 8 weeks. Areas of application were all areas affected, including the scalp, face, trunk, and intertriginous regions. There was a 1-week follow-up period after completing treatment.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious AEs met the 5% reporting cutoff.
    Serious adverse events
    		 Roflumilast Foam 0.3% Vehicle Foam
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 198 (0.51%)
    0 / 104 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Reproductive system and breast disorders
    Testicular torsion
         subjects affected / exposed
    1 / 198 (0.51%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Roflumilast Foam 0.3% Vehicle Foam
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 198 (0.00%)
    0 / 104 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2020
    AM1: The primary purpose was to remove the 10% enrollment limits on Baseline S-IGA & B-IGA mild and severe scores.
    22 Apr 2020
    AM2: The primary purpose was to remove the inclusion of S-IGA mild.

    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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