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    Clinical Trial Results:
    Efficacy of topic RV3131A-HC3221 in the prevention of polymorphic light eruption

    Summary
    EudraCT number
    		 2004-001241-14
    Trial protocol
    		 AT   DE   GB   SE  
    Global end of trial date
    14 Feb 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2019
    First version publication date
    31 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V00096 CR 201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pierre Fabre Dermatologie represented by INSTITUT DE RECHERCHE PIERRE FABRE
    Sponsor organisation address
    45 place Abel Gance, Boulogne, France, 92100
    Public contact
    Pierre MORINET, MD, Institut de Recherche Pierre Fabre, +33 (0)5.62.24.76.52,
    Scientific contact
    Pierre MORINET, MD, Institut de Recherche Pierre Fabre, +33 (0)5.62.24.76.52,
    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
    14 Feb 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Feb 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The evaluation of the efficacy of the sunscreen RV 3131 A HC 3221 on the prevention of Polymorphic Light Eruption (PMLE) among subjects having PMLE history and for whom the diagnosis will be confirmed by a photobiologic exploration.
    Protection of trial subjects
    The study was conducted in accordance with Good Clinical Practice (GCP) based on guidelines of the European Economic Community and French law (20 December 1988, art. L209-7) and on the principles of the Declaration of Helsinki.
    Background therapy
    		 No other topical treatments including cosmetics were allowed on the test areas. However, in the event of a severe skin reaction with rash and/or burning sensation with marked discomfort for the patient, a topical corticosteroid could be prescribed at Day 7.
    Evidence for comparator
    		 This experimental design enabled the effects of any of the 3 strengths (1.0, 1.5 or 2.0 mg/cm²) of test compound to be compared with those of the vehicle alone (2.0 mg) versus untreated control (0 mg) areas in a group of patients with a history of PMLE, each patient being used as his/her own control. The within-individual design had the advantage of minimizing the unknown effect of patient-dependent confounding factors such as skin phototype, disease history, large individual variations in the UV-A1 threshold inducing PMLE reactions.
    Actual start date of recruitment
    28 Sep 2004
    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
    Sweden: 8
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Austria: 19
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    France: 37
    Worldwide total number of subjects
    82
    EEA total number of subjects
    82
    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)
    82
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 82 patients with a phototype II-V skin and a history of Polymorphous light eruption (PMLE) and negative antinuclear antibodies in 10 study centres were randomized.

    Pre-assignment
    Screening details
    		 A total of 90 patients from the usual patient population of the investigationnal sites were screened, however 8 patients were not randomized as they did not comply with inclusion/exlusion criteria. Screening of volunteers was performed prior to the first study drug application.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The test compound and the vehicle were readily distinguishable and applied out of the sight of the investigator. However, the study personnel in charge of the application of the study products had access to the randomization list. A patient card was provided to the patients, with the name of a contact person authorized to give information about the product and the study.

    Arms
    Arm title
    		 Safety population
    Arm description
    		 Test product RV 3131 HC 3221 was applied at doses of 1, 1.5 and 2 mg/ cm²; the vehicle alone was applied at doses of 2 mg/cm² and two areas were not treated (control area for each selected body area). UVA Irradiation (30 J/cm²) was performed 10 to 15 minutes after application.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RV3131A HC3221
    Investigational medicinal product code
    Other name
    V0096CR
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    One application of 1 mg/cm² on one area, one application of 1,5 mg/cm² on one area and one application of 2 mg/cm² on one area over a 1 to 4 day period (Day 0 to Day 3). The 100-ml cream tubes were dispatched in white individual anonymous cases. Each case containing one tube was packed in a polypropylene sealed film.

    Investigational medicinal product name
    Vehicle (inactive ingredients)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    The mean SPF of the vehicle is 1.7. The mean UVA-SPF is 2. One application of 2 mg/cm² on one area over a 1 to 4 day period (Day 0 to Day 3). The 100-ml cream tubes were dispatched in white individual anonymous cases. Each case containing one tube was packed in a polypropylene sealed film.

    Number of subjects in period 1
    		Safety population
    Started
    82
    Completed
    82

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment period Total
    Number of subjects
    		 82 82
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 82 82
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (standard deviation)
    		 34 ± 8 -
    Gender categorical
    Units: Subjects
        Female
    		 68 68
        Male
    		 14 14
    Age at PMLE onset
    Units: Subjects
        Childhood
    		 17 17
        Adulthood
    		 65 65
    Months from the last eruption to screening
    Units: months
        median (standard deviation)
    		 12.74 ± 16.79 -

    End points

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    End points reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 Test product RV 3131 HC 3221 was applied at doses of 1, 1.5 and 2 mg/ cm²; the vehicle alone was applied at doses of 2 mg/cm² and two areas were not treated (control area for each selected body area). UVA Irradiation (30 J/cm²) was performed 10 to 15 minutes after application.

    Primary: Lack of photodermatosis

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    End point title
    		 Lack of photodermatosis [1]
    End point description
    The preventive activity of topic RV 3131 A HC 3221 was evaluated from the lack of photodermatosis development at endpoint on treated areas, with a positive control phototest. A phototest was considered positive if vesicles or papules appeared, and not only erythema, which might be due to irradiation. This criterion corresponds to a clear-cut diagnosis of PMLE flare (grade 1 or 2 on the global severity scale of PMLE flare). The preventive activity of the study treatment on the ITT population led to gradually increasing success rates (no photodermatosis) in 26 patients (76.5 %) treated with 1 mg/cm², 29 patients (85.3 %) with 1.5 mg/cm² and 32 patients (94.1 %) with 2 mg/cm².
    End point type
    Primary
    End point timeframe
    Lack of photodermatosis was measured between the first intake of study drug (Day 0) and Day 7 (clinical evaluation period) in the ITT population (patients with positive phototest on both control areas during the investigational phase N=34)
    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: No statistical analyses have been specified because of the lack of a comparison arm (within-individual study desing)
    End point values
    		 Safety population
    Number of subjects analysed
    34
    Units: not applicable
    32
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from Day 0 (before the first study drug application) to the last visit (Day 15).
    Adverse event reporting additional description
    Adverse events were coded using the MedDRa dictionary. The incidence of AEs was investigated pre-, during and post-treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 82 patients were included in the safety population, which is consistent with the total number of patients who received at least one dose of the study medication.

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 82 (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
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 82 (4.88%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    2 / 82 (2.44%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    1 / 82 (1.22%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 82 (1.22%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2004
    Changes affected the study personnel, the number of patients, evaluation criteria, the ethical basis of the study, the replacement of patients, allocation of treatment, the post-study follow-up, the population analyzed, the primary criterion, safety criteria, the safety analysis, the patient indemnity.
    27 Oct 2004
    Changes affected the study personnel, the tabulated synopsis, the vehicle composition, concomitant treatments, the study schedule, UV-A1 light sources, the wavelength used and the patient indemnity.
    26 Aug 2005
    Changes affected the recruitment period.

    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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