| Eligibility |
Inclusion Criteria:
1. Healthy volunteers of both sexes aged >18 years with a known history of typical PLE on
the chest after intense sun exposure and a last PLE outbreak since at least eight
months,
2. Subject with Phototype I to IV according to the Fitzpatrick classification (1988)
(14),
3. Subject in good health having normal results for the physical examination and medical
antecedents compatible with the study requirements,
4. subject of non-childbearing potential (tubal ligation, hysterectomy, bilateral
ovariectomy), or, subject of childbearing potential who has been, in the opinion of
the Investigator, using an approved method of birth control (e.g. oral contraception
pill or patch, intra-uterine devices, contraceptive implants or vaginal rings,
condoms, bilateral tubal ligation) for at least 1 month prior to first visit. Subject
must agree to continue adequate contraception during the entire study period and for 1
month after the end of the study,
5. Subject who, in the Investigator's opinion, will comply with the requirements of the
protocol (e.g., follow protocol instructions, maintain regular contact to allow
evaluation during the study),
6. Subject agreeing to avoid exposure to UV radiation (tanning beds, phototherapy, and
sunlight) on the whole body for at least six months before the screening visit and for
the whole duration of the study,
7. Subject agreeing to not apply cosmetic, medical or aesthetic treatments out of the
study protocol on the chest during the whole study duration,
8. Healthy subject registered with Social Security in accordance with French law on
interventional research. (Law 2004-806 and its implementing decree n°2006-477 of 26
April 2006).
Exclusion Criteria:
1. Female subject who is pregnant, parturient or breast feeding,
2. Subject of childbearing potential having a positive urinary pregnancy test at Day 1,
3. Subject has a PLE outbreak in the past eight months,
4. Subject has a medical condition or is taking medication that could put him or her at
undue risk,
5. Subject has a pathology that is unstable or risks interfering with the study,
6. Subject is currently receiving treatment that may interfere with interpretation of the
study results,
7. Subject has known or suspected allergies or sensitivities to any of the components of
the study product,
8. Subjects with an underlying pathology, or with a surgical, physical or medical status
which, according to the investigator, could interfere with the interpretation of the
study results such as:
1. Dermatological active pathologies (e.g. acne, psoriasis, eczema, urticaria...) in
particular on the tested area (the chest) or suspicion/antecedents of allergies
to cosmetics,
2. All systemic or local uncontrolled pathologies,
3. S kin anomalies (scars, excessive hair, tattooing…) on the chest,
9. Subjects having been exposed to ultraviolet radiation (UV), natural (sun) or
artificial (tanning salon), in the 6 months before the initial visit or who plans such
an exposure during the study,
10. Subjects having taken a systemic treatment, able to induce an abnormal response to UV,
for more than 5 days during the month preceding inclusion (steroids, non-steroidal
anti-inflammatories such as aspirin, insulin, antihistamines, anti-hypertensives,
antibiotics such as quinolones, tetracyclines, thiazides and fluoroquinolones, and all
other photosensitising treatments) or all treatments capable of inducing an abnormal
response to UV (vitamin A derivatives, psoralen, aminolevulinic acid derivatives…) or
planning to take these treatments during the study,
11. Subjects having applied a local treatment on the chest for more than 2 days during the
2 weeks preceding inclusion (steroids, non-steroidal anti-inflammatories,
antihistamines, antibiotics) and all other cosmetic products in the previous 24 hours,
12. Protected subject as defined in the Articles of the CSP: Article 1121-7: person
deprived of liberty by a judicial or administrative decision, or subject to
psychiatric care or person admitted to a health or social institution for purposes
other than the research. Article 1121-8: adult person subject to a legal protection
measure or unable to express his/her consent.
13. Subject unable to communicate or cooperate with the Investigator due to poor mental
development, language problems or impaired cerebral function,
14. Subject currently participating in another clinical study related to pharmaceuticals
or MDs or being in an exclusion period of another clinical study,
15. Subject who has received (or who will receive) more than 4500 euros as indemnity for
participating in clinical studies within the previous 12 months.
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