E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Polymorphic Light Eruption (PMLE) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | 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 among subjects having PMLE history and for whom the diagnosis will be confirmed by a photobiologic exploration. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last Day 15 phone contact of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |