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    Clinical Trial Results:
    Vitiligo en het Koebnerfenomeen. (Vitiligo inductie- en therapie model : klinische en immunologische analyse)

    Summary
    EudraCT number
    		 2009-017425-19
    Trial protocol
    		 BE  
    Global end of trial date
    15 Sep 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Aug 2024
    First version publication date
    08 Aug 2024
    Other versions
    Summary report(s)
    		 Final Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    AGO/2009/012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, University Hospital Ghent, 32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, University Hospital Ghent, 32 93320500, hiruz.ctu@uzgent.be
    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
    02 Nov 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Analysis of clinical and immunological processes that arise during the induction phase of vitiligo and the influence of topical therapies on this process.
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jan 2010
    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
    Belgium: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 14 patients were screened in the period from dd-mmm-yyyy till dd-mmm-yyyy. 14 patients were included, Y patients were randomised. 12 patients were included and completed the trial. End of trial notification was dated 15-09-2015 (last patient last visit) and submitted to EC and CA 28-03-2019.

    Pre-assignment
    Screening details
    		 Inclusion criteria: PART I and II • Extensive form of vitiligo (> 50% BSA) or vitiligo patients who are under depigmenting / decolouring treatment • Patients who request depigmenting therapy • ≥ 18 years • Not pregnant PART III • Patients without vitiligo who come to the dermatology department for consultation • ≥ 18 years • Not pregnant

    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
    Blinding of the assessor: the clinical evaluation (percentage depigmentation versus pigmentation) will take place based on clinical photos. The assessment of histological material will be based on Skin sections. The assessor is a person who will not receive information about the intervention. Only after completion of the assessment will the randomization code be broken. The creams will be applied ad randomly to one of the selected test zones. Randomization will take place using a draw system

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vaseline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    N/A

    Arm title
    		 tacrolimus treatment
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tacrolimus
    Investigational medicinal product code
    CAS 104987-11-3
    Other name
    Protopic
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Maximum duration of treatment of a subject according to the protocol: 10 days Maximum dose allowed: once a day, Dose per day 0,1 % percent 4 applications (day 1,day 3, day 6 and day 10)

    Arm title
    		 pimecrolimus treatment
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Pimecrolimus
    Investigational medicinal product code
    CAS 137071-32-0
    Other name
    Elidel
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Maximum duration of treatment of a subject according to the protocol: 10 days Maximum dose allowed: once a day, Dose per day, 1% percent. 4 applications (day 1, day 3, day 6 and day 10)

    Arm title
    		 cortisone treatment
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    cortisone
    Investigational medicinal product code
    CAS 13609671
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Maximum duration of treatment of a subject according to the protocol: protocol Maximum dose allowed: once a day Dose per day 1 mg/g milligram(s)/gram 4 applications (day 1, day 3, day 6 and day 10)

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: See attachment Final Study Report
    Number of subjects in period 1
    		Placebo tacrolimus treatment pimecrolimus treatment cortisone treatment
    Started
    3
    3
    3
    3
    Completed
    3
    3
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    tacrolimus treatment
    Reporting group description
    		 -

    Reporting group title
    pimecrolimus treatment
    Reporting group description
    		 -

    Reporting group title
    cortisone treatment
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In total, five patients met the inclusion criteria of our study; however, two patients declined to be enrolled because of logistic reasons. All remaining three patients completed the intervention and the follow-up as planned. All participants were included in the main analysis. Age-eligible participants were recruited among patients attending our clinic for a visit at the time of the inclusion period.
    Reporting group values
    		 Placebo tacrolimus treatment pimecrolimus treatment cortisone treatment Total
    Number of subjects
    		 3 3 3 3 3
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 3 3 3 3 3
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 3 3 3 3 3
        Male
    		 0 0 0 0 0
    Ethnic origin
    Units: Subjects
        Surinamese
    		 1 1 1 1 1
        Caucasian
    		 1 1 1 1 1
        North African
    		 1 1 1 1 1
    skin type
    Units: Subjects
        type 2
    		 1 1 1 1 1
        type 5
    		 1 1 1 1 1
        type 4
    		 1 1 1 1 1
    Total extent depigmentations (BSA, body surface area)
    Units: Subjects
        BSA 60 %
    		 1 1 1 1 1
        BSA 70 %
    		 1 1 1 1 1
        BSA 65%
    		 1 1 1 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    tacrolimus treatment
    Reporting group description
    		 -

    Reporting group title
    pimecrolimus treatment
    Reporting group description
    		 -

    Reporting group title
    cortisone treatment
    Reporting group description
    		 -

    Primary: percentage of skin pigmentation in the treated area

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    End point title
    		 percentage of skin pigmentation in the treated area [1]
    End point description
    End point type
    Primary
    End point timeframe
    1 month
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: See attachment Final Study Report
    End point values
    		 Placebo tacrolimus treatment pimecrolimus treatment cortisone treatment
    Number of subjects analysed
    3
    3
    3
    3
    Units: pigmentation (%)
        arithmetic mean (standard deviation)
    3 ( 3 )
    3 ( 3 )
    3 ( 3 )
    3 ( 3 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    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 adverse events were recorded for the participating patients.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2010
    Amendment 1: Reasons for the substantial amendment: - Choice of local corticosteroid was changed from Locoid cream to Elocom cream - Modification of inclusion and exclusion criteria Brief description of the changes: - Choice of local corticosteroid was changed from Locoid cream to Elocom cream - As a result of the decision to include only adult patients in the study, the inclusion and exclusion criteria were modified so that only patients aged 18 years or older will be able to participate in the study
    02 Apr 2010
    Amendment 2: Reasons for the substantial amendment: - Change in the taking of biopsies on day 3, 10, 30 and 60 - Change in the number of applications of the products Brief description of the changes: - Change in the taking of biopsies on day 3, 10, 30 and 60 - Change in the number of applications of the products
    26 Sep 2012
    Amendment 3: Comments/explanation/reasons for substantial amendment: - The research project was expanded to include a 2nd and a 3rd research part (parts 2 and 3). In part 1, cream therapies with an active ingredient will be evaluated in patients with vitiligo. On the control areas, vaseline will no longer be used but a neutral moisturizing cream without an active ingredient (Cold Cream Lipo Cream from Fagron). In this part 1, there will also be control zones where no cream therapy will be applied. In part 2 of the study, we will mainly focus on the control group from part 1. This part of the study will consist of an additional group of vitiligo patients, where no additional cream therapy or only a cream therapy without active ingredient (moisturizer, Cold Cream Lipo cream) will be applied after the elicitation test. In part 3, we will focus on a control group that will consist of patients without vitiligo, on whom we will only do the vitiligo elicitation tests in order to induce a skin reaction - the number of subjects who participate in this study was changed: part 1: 15 patients part 2: 20 patients part 3: 10 patients - Vaseline will no longer be used on the control areas but a neutral moisturizing cream without active ingredient: Cold Cream Lipo Cream from Fagron.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/21982055
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