Efficacy of topic RV3131A-HC3221 in the prevention of polymorphic light eruption - NA

• Register: EUCTR
• Last refreshed on: 15 July 2013
• Main ID: EUCTR2004-001241-14-AT
• Date of registration: 08/10/2004
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Dermatologie represented by Institut de Recherche Pierre Fabre
• Public title: Efficacy of topic RV3131A-HC3221 in the prevention of polymorphic light eruption - NA
• Scientific title: Efficacy of topic RV3131A-HC3221 in the prevention of polymorphic light eruption - NA
• Date of first enrolment: 12/11/2004
• Target sample size: 45
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001241-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria, Germany, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female patients aged between 18 and 45 years, phototype II to IV according to Fitzpatrick's classification- Appendix 8.
2. Patients with an history of PMLE:
3. photosensitivity arising in early spring and worsening as summer progresses with lesions on the face
4. or photosensitivity arising in early spring but becoming less severe as summer progresses and the face is spared
5. Patients with negative results to antinuclear antibodies, SS-A (Ro) antibodies and SS-B (La) antibodies searching
6. For French patients, covered by Social Security System.
7. Aware of the study constraints and accepting them.
8. Female patients must use a reliable form of contraception (i.e. oral hormonal contraceptives, intra-uterine device or condom, ligating of uterine tubes) since at least 3 months, during the trial and one month after.
9. Female patients must have a negative urine pregnancy test at Day 0.
10. Understanding of the study and agreement to give a written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patients who had a PMLE eruption during the month preceding the screening.
2. Patients who have a history of major medical/psychiatric illness or surgery, which, according to the judgement of the investigator put them 'at risk', particularly other photodermatosis.
3. Patients with a significant history of alcoholism or drug abuse.
4. Patients who have a history of hypersensitivity to at least one of the test products (sunscreen) or their vehicles.
5. Patients who had been sunburned in the last month or who plan to be exposed to sun or UV light on the experimental area during the study.
6. Patients who suffer from any acute or chronic systemic disease or disorder.
7. Patients who have forfeited their freedom by administrative or legal award or who are under guardianship.
8. Patients hospitalised in a medical or social establishment for an other reason than biomedical research.
9. Any participation to a clinical study during the 3 months preceding the screening visit, and 3 months following the study.
10. Pregnant or lactating women.
11. Patients who have received photoprotective treatments, photosensitive treatments, systemic corticosteroids or non steroidal anti-inflammatory drug within 4 weeks prior to the start of the study.
12. Patients who have a cutaneous lesion or scar in the test regions.
13. Patients likely to develop cheloid scars.
14. French patient registered as being in exclusion period in the French Health Minister File of volunteers.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Polymorphic Light Eruption (PMLE)

Intervention(s)

Product Name: NA
Product Code: RV3131A-HC3221
Pharmaceutical Form: Cream
Pharmaceutical form of the placebo: Cream
Route of administration of the placebo: Topical use (Noncurrent)

Product Name: NA
Product Code: RV3131A-HC3221
Pharmaceutical Form: Cream

Primary Outcome(s)

Main Objective: The evaluation of the efficacy of the sunscreen RV 3131 A HC 3221 on the prevention of Polymorphic Light Eruption among subjects having PMLE history and for whom the diagnosis will be confirmed by a photobiologic exploration.

Primary end point(s): Preventive activity of the topic RV 3131 A HC 3221 will be evaluated by the absence at the endpoint of the photodermatosis setting on the treated areas with a positive control phototest. A phototest will be considered as positive if vesicles or papules appear and not only erythema which may be due to the irradiation. This criteria corresponds to a clear cut diagnosis of PMLE flare (grade 1 or 2 on the global severity scale of PMLE flare).

Secondary Objective: The evaluation of the optimal dose of sunscreen to apply to have the preventive efficacy
The evaluation of the intensity of the PMLE reaction using a Global reaction severity scale constructed for the study
The evaluation of time to setting of PMLE flare
The evaluation of intensity of erythema, pruritis and burning/stinging and the total lesion count (papules, vesicles and plaques)
The assessment of the overall tolerability

Secondary ID(s)

V00096 CR 201