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    Clinical Trial Results:
    Investigation of the effectiveness, tolerability and safety of ilon® Salbe classic in the treatment of acute inflammation of the hair follicle (folliculitis) - Prospective, open, evaluator-blinded, randomized, placebo-controlled multicenter trial Investigation of the effectiveness, tolerability and safety of ilon® Salbe classic in the treatment of acute inflammation of the hair follicle (folliculitis) - Prospective, open, randomized, placebo-/comparator controlled multicenter trial (previous title – feasibility study)

    Summary
    EudraCT number
    		 2016-005105-39
    Trial protocol
    		 DE  
    Global end of trial date
    08 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2023
    First version publication date
    08 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CES ISC 001/16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Cesra Arzneimittel GmbH & Co.KG
    Sponsor organisation address
    Braunmattstraße 20, Baden-Baden, Germany, 76532
    Public contact
    MedWiss, Cesra Arzneimittel GmbH & Co.KG, 0049 72219540380, Christian.Zimmermann@cesra.de
    Scientific contact
    MedWiss, Cesra Arzneimittel GmbH & Co.KG, 0049 72219540380, Christian.Zimmermann@cesra.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
    19 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial was to obtain information about the efficacy, tolerability and safety of ilon® Salbe classic (ISC) in the treatment of acute folliculitis.
    Protection of trial subjects
    The trial was conducted in accordance with the principles of ICH GCP, the declaration of Helsinki, as well as all other applicable ethical and legal requirements. Before being included in the trial, the subjects were informed in detail by the investigators about all pertinent aspects of the trial. Subjects were free to terminate their participation in the trial at any time without personal disadvantages and without giving reasons. Any individual subject medical information obtained as a result of this trial was considered confidential and disclosure to third parties is prohibited. Subject confidentiality was further ensured by utilizing subject identification code numbers to correspond to treatment data in the computer files. All investigational medicinal products used in this trial are already registered and commercially available. Given their quality and reliability, only very minimal risks were considered to be encountered during the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jun 2017
    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: 171
    Worldwide total number of subjects
    171
    EEA total number of subjects
    171
    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)
    162
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was divided in two phases - a feasibility and a main study. The feasibility study was conducted with three arms (ISC, placebo, comparator) in 6 sites in Germany from Jul20217 to Mar2018. The main study was conducted with two arms (ISC, placebo) in 11 sites in Germany from Dec2019 to Feb2022.

    Pre-assignment
    Screening details
    		 feasibility study: 70 eligible patients were randomized to either of the three treatment arms. main study: Overall, 127 patients signed an ICF and were assessed for eligibility. 26 out of these did not satisfy the in-/exclusion criteria, and 101 were randomized into either of two treatment arms.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    Effectiveness was evaluated on the basis of the primary outcome, the change in total folliculitis lesion counts. For this, the respective treatment area was documented photographically. These photos were transferred to the CRO and analyzed centrally by independent dermatologists in a blinded manner.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 feasibility - ISC
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ilon® Salbe classic
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    The individual single dose of ISC: a maximum of 2 cm cord of ointment applied twice daily, for a maximum of 7 days. The trial medication was administered by the study site staff during each visit. At home, the trial medication was administered by the patient twice a day on the Investigator-defined treatment area.

    Arm title
    		 feasibility - PLAC
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vaselin Salbe LAW, 100%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    The individual single dose of placebo: a maximum of 2 cm cord of ointment applied twice daily, for a maximum of 7 days. The trial medication was administered by the study site staff during each visit. At home, the trial medication was administered by the patient twice a day on the Investigator-defined treatment areas.

    Arm title
    		 feasibility - PVI
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Polysept® Lösung
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous solution
    Routes of administration
    Topical use
    Dosage and administration details
    The individual single dose of PVI: a maximum of 5 ml applied twice daily, for a maximum of 7 days. The trial medication was administered by the study site staff during each visit. At home, the trial medication was administered by the patient twice a day on the Investigator-defined treatment areas.

    Arm title
    		 main - ISC
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ilon® Salbe classic
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    The individual single dose of ISC: 2 - 3 cm cord of ointment applied twice daily on folliculitis lesions within the predefined skin area of 5x5 cm, for a maximum of 15 days. The trial medication was administered during each visit. At home, the trial medication was administered by the patient twice a day on the Investigator-defined treatment area.

    Arm title
    		 main - PLAC
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vaselin Salbe LAW, 100%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    The individual single dose of placebo: 2 - 3 cm cord of ointment applied twice daily on folliculitis lesions within the predefined skin area of 5x5 cm, for a maximum of 15 days. The trial medication was administered by the study site staff during each visit. At home, the trial medication was administered by the patient twice a day on the Investigator-defined treatment areas.

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This clinical trials was conducted as open trial, i.e. investigators, patients etc. were aware of the treatment allocation. The assessment of the photographic documentation was performed centrally by independent persons - and these were blinded.
    Number of subjects in period 1
    		feasibility - ISC feasibility - PLAC feasibility - PVI main - ISC main - PLAC
    Started
    21
    25
    24
    50
    51
    Completed
    21
    25
    23
    47
    48
    Not completed
    0
    0
    1
    3
    3
         premature healing
    -
    -
    1
    -
    1
         Adverse event, non-fatal
    -
    -
    -
    2
    -
         Lost to follow-up
    -
    -
    -
    1
    1
         Lack of efficacy
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    feasibility - ISC
    Reporting group description
    		 -

    Reporting group title
    feasibility - PLAC
    Reporting group description
    		 -

    Reporting group title
    feasibility - PVI
    Reporting group description
    		 -

    Reporting group title
    main - ISC
    Reporting group description
    		 -

    Reporting group title
    main - PLAC
    Reporting group description
    		 -

    Reporting group values
    		 feasibility - ISC feasibility - PLAC feasibility - PVI main - ISC main - PLAC Total
    Number of subjects
    		 21 25 24 50 51 171
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0 0 0
        From 65-84 years
    		 0 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0 0
        18-69 years
    		 20 24 22 49 50 165
        70-75 years
    		 1 1 2 1 1 6
    Gender categorical
    Units: Subjects
        Female
    		 11 11 14 26 30 92
        Male
    		 10 14 10 24 21 79

    End points

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    End points reporting groups
    Reporting group title
    feasibility - ISC
    Reporting group description
    		 -

    Reporting group title
    feasibility - PLAC
    Reporting group description
    		 -

    Reporting group title
    feasibility - PVI
    Reporting group description
    		 -

    Reporting group title
    main - ISC
    Reporting group description
    		 -

    Reporting group title
    main - PLAC
    Reporting group description
    		 -

    Primary: main - change in total follicle lesion counts from Day 1 to the day of study completion

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    End point title
    		 main - change in total follicle lesion counts from Day 1 to the day of study completion [1]
    End point description
    main study - change in total follicle lesion counts from Day 1 to the day of study completion (ITT population)
    End point type
    Primary
    End point timeframe
    main study: from Day 1 to the day of study completion
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The clinical trial was divided in two phases - a feasibility and a main study. As the system did not allow creation of two separate study periods to distinguish between feasibility and main study, both parts have been documented as one (overall) but with a total of 5 treatment arms (3x for feasibility and 2x for main study). Analyses have been conducted separately, though. Consequently, statistics are only available and provided for the respective study part.
    End point values
    		 main - ISC main - PLAC
    Number of subjects analysed
    49
    51
    Units: change in number of follicle lesions
        arithmetic mean (standard deviation)
    -1.7 ± 4.51
    -2.2 ± 3.66
    Statistical analysis title
    		 ISC - superiority
    Statistical analysis description
    ISC will be compared to Placebo using ANOVA adjusted for day 1 values.
    Comparison groups
    main - ISC v main - PLAC
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2723
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 0.6
    Variability estimate
    Standard deviation
    Dispersion value
    3.2

    Primary: feasibility - change in follicle lesion counts from Day 0 to the Final Visit

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    End point title
    		 feasibility - change in follicle lesion counts from Day 0 to the Final Visit [2]
    End point description
    feasibility study - change in follicle lesion counts from Day 0 to the Final Visit (subjects with evaluable photographic documentation)
    End point type
    Primary
    End point timeframe
    feasibility study - from Day 0 to the Final Visit
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The clinical trial was divided in two phases - a feasibility and a main study. As the system did not allow creation of two separate study periods to distinguish between feasibility and main study, both parts have been documented as one (overall) but with a total of 5 treatment arms (3x for feasibility and 2x for main study). Analyses have been conducted separately, though. Consequently, statistics are only available and provided for the respective study part.
    End point values
    		 feasibility - ISC feasibility - PLAC feasibility - PVI
    Number of subjects analysed
    16 [3]
    17 [4]
    15 [5]
    Units: change in number of follicle lesions
        arithmetic mean (standard deviation)
    -0.9 ± 5.25
    0.4 ± 3.83
    -1.3 ± 5.86
    Notes
    [3] - subjects with evaluable photographic documentation
    [4] - subjects with evaluable photographic documentation
    [5] - subjects with evaluable photographic documentation
    Statistical analysis title
    		 feasibility - superiority ISC vs. PLAC
    Statistical analysis description
    feasibility study - Superiority of ISC to placebo was analyzed using ANOVA adjusted for Day 0 values.
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5243
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 3.6
    Variability estimate
    Standard deviation
    Dispersion value
    3.8

    Primary: feasibility - improvement

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    End point title
    		 feasibility - improvement [6]
    End point description
    feasibility study - improvement; subjects with reduction in number of follicle lesions by at least one count (subjects with evaluable photographic documentation)
    End point type
    Primary
    End point timeframe
    feasibility study - from Day 0 to the Final Visit
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The clinical trial was divided in two phases - a feasibility and a main study. As the system did not allow creation of two separate study periods to distinguish between feasibility and main study, both parts have been documented as one (overall) but with a total of 5 treatment arms (3x for feasibility and 2x for main study). Analyses have been conducted separately, though. Consequently, statistics are only available and provided for the respective study part.
    End point values
    		 feasibility - ISC feasibility - PLAC feasibility - PVI
    Number of subjects analysed
    16 [7]
    17 [8]
    15 [9]
    Units: number of subjects with improvement
    9
    3
    10
    Notes
    [7] - subjects with evaluable photographic documentation
    [8] - subjects with evaluable photographic documentation
    [9] - subjects with evaluable photographic documentation
    Statistical analysis title
    		 feasibility - improvement rate ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Wald
    Parameter type
    		 rate difference
    Point estimate
    -38.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -68.92
         upper limit
    		 -8.28

    Secondary: feasibility - general assessment according to observers

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    End point title
    		 feasibility - general assessment according to observers [10]
    End point description
    feasibility study - Observers (blinded) gave an overall assessment of treatment success based on photographs
    End point type
    Secondary
    End point timeframe
    feasibility study - from Day 0 to the Final Visit
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The clinical trial was divided in two phases - a feasibility and a main study. As the system did not allow creation of two separate study periods to distinguish between feasibility and main study, both parts have been documented as one (overall) but with a total of 5 treatment arms (3x for feasibility and 2x for main study). Analyses have been conducted separately, though. Consequently, statistics are only available and provided for the respective study part.
    End point values
    		 feasibility - ISC feasibility - PLAC feasibility - PVI
    Number of subjects analysed
    21 [11]
    25 [12]
    24 [13]
    Units: number of subjects
        worse
    2
    4
    4
        unchanged
    5
    10
    12
        improved
    14
    11
    8
    Notes
    [11] - ITT population
    [12] - ITT population
    [13] - ITT population
    Statistical analysis title
    		 feasibility - general assessment ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.149
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 feasibility - general assessment ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.038
    Method
    		 Fisher exact
    Confidence interval

    Secondary: feasibility - course of total follicle lesion counts

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    End point title
    		 feasibility - course of total follicle lesion counts [14]
    End point description
    feasibility study - course of total follicle lesion counts assessed by subjects’ daily photographic documentation (ITT population)
    End point type
    Secondary
    End point timeframe
    feasibility study - from Day 0 to the Final Visit
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The clinical trial was divided in two phases - a feasibility and a main study. As the system did not allow creation of two separate study periods to distinguish between feasibility and main study, both parts have been documented as one (overall) but with a total of 5 treatment arms (3x for feasibility and 2x for main study). Analyses have been conducted separately, though. Consequently, statistics are only available and provided for the respective study part.
    End point values
    		 feasibility - ISC feasibility - PLAC feasibility - PVI
    Number of subjects analysed
    21 [15]
    25 [16]
    24 [17]
    Units: number of follicle lesions
    arithmetic mean (standard deviation)
        day 0
    5.2 ± 4.85
    4.3 ± 3.07
    5.3 ± 5.65
        day 1
    5.0 ± 4.13
    5.9 ± 5.84
    4.0 ± 3.57
        day 2
    5.4 ± 5.90
    5.0 ± 5.21
    3.4 ± 3.15
        day 3
    4.9 ± 5.01
    5.3 ± 7.00
    3.2 ± 2.44
        day 4
    4.8 ± 4.11
    5.3 ± 4.19
    3.1 ± 2.26
        day 5
    3.4 ± 3.69
    5.9 ± 5.05
    2.7 ± 1.67
        day 6
    2.6 ± 2.16
    3.9 ± 3.17
    3.3 ± 2.31
        day 7
    1.3 ± 1.34
    3.3 ± 3.25
    3.6 ± 3.05
    Notes
    [15] - ITT population
    [16] - ITT population
    [17] - ITT population
    No statistical analyses for this end point

    Secondary: feasibility - final assessment of the study medication

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    End point title
    		 feasibility - final assessment of the study medication [18]
    End point description
    feasibility study - The study medication was finally assessed by the subjects with respect to different parameters (rating scale 0-10) (ITT population)
    End point type
    Secondary
    End point timeframe
    feasibility study - Final Visit
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The clinical trial was divided in two phases - a feasibility and a main study. As the system did not allow creation of two separate study periods to distinguish between feasibility and main study, both parts have been documented as one (overall) but with a total of 5 treatment arms (3x for feasibility and 2x for main study). Analyses have been conducted separately, though. Consequently, statistics are only available and provided for the respective study part.
    End point values
    		 feasibility - ISC feasibility - PLAC feasibility - PVI
    Number of subjects analysed
    21 [19]
    25 [20]
    24 [21]
    Units: value according to rating scale
    arithmetic mean (standard deviation)
        General effectiveness
    5.8 ± 2.98
    3.7 ± 2.99
    6.3 ± 2.77
        Impact on pain
    5.9 ± 2.70
    4.0 ± 3.11
    5.9 ± 3.24
        Application sensation
    8.0 ± 2.79
    7.3 ± 2.79
    7.4 ± 2.95
        Distributability
    8.3 ± 2.55
    7.7 ± 2.62
    7.5 ± 3.12
        Skin sensation
    8.2 ± 2.68
    7.2 ± 2.74
    7.6 ± 2.39
        Smell
    8.3 ± 2.33
    7.8 ± 2.50
    6.8 ± 3.12
        Color
    6.8 ± 2.77
    8.0 ± 1.99
    4.3 ± 3.04
        Skin compatibility
    8.5 ± 2.56
    9.0 ± 2.05
    8.9 ± 1.88
    Notes
    [19] - ITT population
    [20] - ITT population
    [21] - ITT population
    Statistical analysis title
    		 feasibility - general effectiveness ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.029
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - general effectiveness ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.589
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - impact on pain ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.077
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - impact on pain ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.966
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - application sensation ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.279
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - application sensation ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.303
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - distributability ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.506
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - distributability ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.366
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - skin sensation ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.154
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - skin sensation ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.214
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - smell ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.686
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - smell ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.147
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - color ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.153
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - color ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.009
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - skin compatibility ISC vs. PLAC
    Comparison groups
    feasibility - ISC v feasibility - PLAC
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.396
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 feasibility - skin compatibility ISC vs. PVI
    Comparison groups
    feasibility - ISC v feasibility - PVI
    Number of subjects included in analysis
    45
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.959
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from when the subject signed the Informed Consent to the end of subject’s participation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    feasibility - ISC
    Reporting group description
    		 -

    Reporting group title
    feasibility - PLAC
    Reporting group description
    		 -

    Reporting group title
    feasibility - PVI
    Reporting group description
    		 -

    Reporting group title
    main - ISC
    Reporting group description
    		 -

    Reporting group title
    main - PLAC
    Reporting group description
    		 -

    Serious adverse events
    		 feasibility - ISC feasibility - PLAC feasibility - PVI main - ISC main - PLAC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 feasibility - ISC feasibility - PLAC feasibility - PVI main - ISC main - PLAC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 25 (8.00%)
    2 / 24 (8.33%)
    4 / 50 (8.00%)
    1 / 51 (1.96%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 50 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Application site hypersensitivity
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Application site irritation
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Application site pruritus
         subjects affected / exposed
    2 / 21 (9.52%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
         occurrences all number
    2
    1
    0
    1
    0
    Application site erythema
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 25 (4.00%)
    0 / 24 (0.00%)
    1 / 50 (2.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Contact dermatitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 25 (0.00%)
    1 / 24 (4.17%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Reddening
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 25 (0.00%)
    2 / 24 (8.33%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Gastrointestinal disorders
    Diarrhea
    Additional description: Nausea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    0 / 50 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 25 (0.00%)
    0 / 24 (0.00%)
    1 / 50 (2.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Nov 2019
    Version 2.0 (2.1) switch from feasibility to main study
    24 Jul 2020
    Version 3.0 Prolongation of recuitment period
    11 May 2021
    Version 4.0 Prolongation of recruitment period

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    18 Mar 2020
    As it could not be excluded that Corona situation and resulting restrictions have an impact on protocol compliant conduct of the clinical trial, recruitment of new study participants was temporarily stopped.
    14 May 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    - treatment duration: 7d (feasibility) vs. 14 d (main) - observations in main study were limited to d7 and d14 with no additional visits planned in-between - evaluation of photographic material less accurate as in person at medical visit
    For support, Contact us.
    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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