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    Clinical Trial Results:
    A multi-center, randomized, double-blind, phase II trial with intraindividual comparison to assess superiority of Soventol HydroCortisonACETAT 1 % Cremogel versus vehicle on lesional skin in patients with mild atopic eczema, seborrheic eczema or stasis dermatitis and to assess safety of Soventol HydroCortisonACETAT 1 % Cremogel

    Summary
    EudraCT number
    		 2017-000984-34
    Trial protocol
    		 DE  
    Global end of trial date
    19 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    6630-9170-917016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 bioskin trial no.: 370404BS
    Sponsors
    Sponsor organisation name
    MEDICE Arzneimittel Puetter GmbH & Co. KG
    Sponsor organisation address
    Kuhloweg 37, Iserlohn, Germany, 58638
    Public contact
    Medical Department, MEDICE Arzneimittel Puetter GmbH & Co. KG, +492371 9370, medinfo@medice.de
    Scientific contact
    Medical Department, MEDICE Arzneimittel Puetter GmbH & Co. KG, +492371 9370, medinfo@medice.de
    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
    13 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the superiority of Soventol HydroCortisonACETAT 1 % Cremogel versus vehicle and to assess safety of Soventol HydroCortisonACETAT 1 % Cremogel
    Protection of trial subjects
    A specific treatment was to be discontinued if a treatment area showed worsening effects after one week of treatment. Since the appearance of the skin disease was described by several criteria (edema/papulation, oozing/crusts, excoriations, scaling and lichenification) discontinuation of special test areas was to be determined at the discretion of the investigator.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jan 2018
    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: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    47
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The participants were selected via advertisment and from the patient pool of the 4 selected trial sites

    Pre-assignment
    Screening details
    		 52 patients were randomized in this trial. 51 patients were with normal trial completion and 1 subject had discontinued the trial since exclusion criterion 10 was met .

    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
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Soventol HydroCortisonACETAT 1% Cremogel
    Arm description
    		 Soventol HydroCortisonACETAT 1% Cremogel
    Arm type
    		 Experimental

    Investigational medicinal product name
    Soventol HydroCortisonACETAT 1% Cremogel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Up to 3 FTUs corresponding to approximately 1.5 g of the IMPs (Soventol HydroCortisonACETAT 1% Cremogel and the active ingredient-free vehicle) were applied to the respective treatment areas three times daily (morning, noon and evening) over a 2-week treatment period by the patient. The applied IMPs were distributed equally in the test areas using finger stalls. The time between the two applications should have included minimum 3 hours and maximum 18 hours.

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Up to 3 FTUs corresponding to approximately 1.5 g (5) of the IMPs (Soventol HydroCortisonACETAT 1% Cremogel and the active ingredient-free vehicle) were applied to the respective treatment areas three times daily (morning, noon and evening) over a 2-week treatment period by the patient. The applied IMPs were distributed equally in the test areas using finger stalls. The time between the two applications should have included minimum 3 hours and maximum 18 hours.

    Number of subjects in period 1
    		Soventol HydroCortisonACETAT 1% Cremogel Placebo
    Started
    52
    52
    Completed
    51
    51
    Not completed
    1
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 52 52
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 47 47
        From 65-84 years
    		 5 5
    Gender categorical
    Units: Subjects
        Female
    		 32 32
        Male
    		 20 20
    Subject analysis sets

    Subject analysis set title
    safety evaluation set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set comprised of all patients who recieved any IMP at least once.

    Subject analysis set title
    full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS included all randomized patients who received at least one dose of IMP, and had at least one post-baseline assessment

    Subject analysis set title
    valid case set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The VCS included all patients of the FAS without any major protocol deviation, i.e. any deviation which conflicted with the trial aims.

    Subject analysis set title
    Posthoc subgroup
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Posthoc analyses focusing on a subgroup of patients only including patients with mild to moderate erythema (scores 2 and 3) were performed; excluding patients with baseline assessment ‘very mild erythema’

    Subject analysis sets values
    		 safety evaluation set full analysis set valid case set Posthoc subgroup
    Number of subjects
    52
    52
    50
    46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    47
    47
    45
    41
        From 65-84 years
    5
    5
    5
    5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.5 ( 18.4 )
    38.5 ( 18.4 )
    38.7 ( 18.8 )
    38.5 ( 18.4 )
    Gender categorical
    Units: Subjects
        Female
    32
    32
    32
    30
        Male
    20
    20
    18
    16

    End points

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    End points reporting groups
    Reporting group title
    Soventol HydroCortisonACETAT 1% Cremogel
    Reporting group description
    		 Soventol HydroCortisonACETAT 1% Cremogel

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Subject analysis set title
    safety evaluation set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set comprised of all patients who recieved any IMP at least once.

    Subject analysis set title
    full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The FAS included all randomized patients who received at least one dose of IMP, and had at least one post-baseline assessment

    Subject analysis set title
    valid case set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The VCS included all patients of the FAS without any major protocol deviation, i.e. any deviation which conflicted with the trial aims.

    Subject analysis set title
    Posthoc subgroup
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Posthoc analyses focusing on a subgroup of patients only including patients with mild to moderate erythema (scores 2 and 3) were performed; excluding patients with baseline assessment ‘very mild erythema’

    Primary: Erythema Scores (full analysis set)

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    End point title
    		 Erythema Scores (full analysis set)
    End point description
    End point type
    Primary
    End point timeframe
    The severity of the lesions was clinically assessed by the blinded investigator on Days 1, 3, 8 and 15
    End point values
    		 Soventol HydroCortisonACETAT 1% Cremogel Placebo
    Number of subjects analysed
    52
    52
    Units: AUC
        arithmetic mean (standard error)
    -13.0 ( 8.4 )
    -10.9 ( 9.6 )
    Statistical analysis title
    		 Erytheme Scores - AUC comparisons (FAS)
    Comparison groups
    Placebo v Soventol HydroCortisonACETAT 1% Cremogel
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1173
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Median difference (final values)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 1.3
    Variability estimate
    Standard deviation
    Dispersion value
    10.4

    Primary: Erythema Scores - AUC comparison (valid case set)

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    End point title
    		 Erythema Scores - AUC comparison (valid case set)
    End point description
    End point type
    Primary
    End point timeframe
    The severity of the lesions was clinically assessed by the blinded investigator on Days 1, 3, 8 and 15
    End point values
    		 Soventol HydroCortisonACETAT 1% Cremogel Placebo
    Number of subjects analysed
    50
    50
    Units: AUC
        arithmetic mean (standard deviation)
    -13.1 ( 8.5 )
    -10.5 ( 9.6 )
    Statistical analysis title
    		 Erythema Scores - AUC comparison (VCS)
    Comparison groups
    Soventol HydroCortisonACETAT 1% Cremogel v Placebo
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0486
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Median difference (final values)
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    10.3

    Primary: Erythema Scores - AUC comparison (post hoc analysis)

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    End point title
    		 Erythema Scores - AUC comparison (post hoc analysis)
    End point description
    End point type
    Primary
    End point timeframe
    The severity of the lesions was clinically assessed by the blinded investigator on Days 1, 3, 8 and 15
    End point values
    		 Soventol HydroCortisonACETAT 1% Cremogel Placebo
    Number of subjects analysed
    46
    46
    Units: AUC
        arithmetic mean (standard deviation)
    -14.1 ( 8.0 )
    -11.2 ( 10.1 )
    Statistical analysis title
    		 Erythema Scores - AUC comparison (post hoc)
    Comparison groups
    Soventol HydroCortisonACETAT 1% Cremogel v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.0349
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Median difference (final values)
    Point estimate
    -2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    10.8

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded throughout the entire trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    all subjects
    Reporting group description
    		 -

    Serious adverse events
    		 all subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 all subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 52 (7.69%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 52 (7.69%)
         occurrences all number
    4

    More information

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

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

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