Clinical Trial Results:
Efficacy of topic RV3131A-HC3221 in the prevention of polymorphic light eruption
Summary
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EudraCT number |
2004-001241-14 |
Trial protocol |
AT DE GB SE |
Global end of trial date |
14 Feb 2006
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Jan 2019
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First version publication date |
31 Jan 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V00096 CR 201
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Pierre Fabre Dermatologie represented by INSTITUT DE RECHERCHE PIERRE FABRE
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Sponsor organisation address |
45 place Abel Gance, Boulogne, France, 92100
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Public contact |
Pierre MORINET, MD, Institut de Recherche Pierre Fabre, +33 (0)5.62.24.76.52,
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Scientific contact |
Pierre MORINET, MD, Institut de Recherche Pierre Fabre, +33 (0)5.62.24.76.52,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Feb 2006
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Feb 2006
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Feb 2006
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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.
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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
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Sweden: 8
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Country: Number of subjects enrolled |
United Kingdom: 4
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Country: Number of subjects enrolled |
Austria: 19
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Country: Number of subjects enrolled |
Germany: 14
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Country: Number of subjects enrolled |
France: 37
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Worldwide total number of subjects |
82
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EEA total number of subjects |
82
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
82
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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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
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Randomised - controlled
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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.
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Arms
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Arm title
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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
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Investigational medicinal product code |
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Other name |
V0096CR
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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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.
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Investigational medicinal product name |
Vehicle (inactive ingredients)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Cream
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Routes of administration |
Topical use
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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.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Safety population
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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. |
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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.
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End point type |
Primary
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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)
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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) |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse events were reported from Day 0 (before the first study drug application) to the last visit (Day 15).
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Adverse event reporting additional description |
Adverse events were coded using the MedDRa dictionary. The incidence of AEs was investigated pre-, during and post-treatment.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||
Dictionary version |
11.0
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Reporting groups
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Reporting group title |
Safety population
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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. | ||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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. |
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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. |
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26 Aug 2005 |
Changes affected the recruitment period. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |