A 4-weeks Comparative Study of Cosmetic Product Versus Standard Medical Care in Subjects With Seborrheic Dermatitis

This study is conducted as a monocentric, randomized, controlled and blinded-label study, in parallel groups.

A total number of 90 subjects included and randomized in 3 parallel groups:

• Test group RV5263A - WS0060 cosmetic product
• Comparative group: RV5263A - LC3302 cosmetic product
• Standard medical care group

6 visits are planned:

• Visit 1: Inclusion (Day 1)
• Visit 2: Intermediate visit (Day 4)
• Visit 3: Intermediate visit (Day 7)
• Visit 4: Intermediate visit (Day 15 ± 1 day)
• Visit 5: Intermediate visit (Day 22 ± 3 days)
• Visit 6: End-of-study visit (Day 29 ± 3 days)

Inclusion criteria

• Male or Female aged between 18 and 70 years included
• Subject affiliated to a social security system or health insurance, or is a beneficiary if applicable
• Subject having a squamous state of the scalp:

• clinically visible (Squire score ≥ 20),
• recurrent (at least twice a year)
• having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization
• Subject having a recent prescription of Standard Medical Care (Ketoconazole 2%) not yet initiated
• Subject accepting that according to the randomization, the Standard Medical Care can be possibly replaced by another shampoo, including neutral shampoo
• Subject having a maximum usual shampoo frequency of 3/week

Non Inclusion criteria

• Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
• Subject having any other dermatologic condition than the studied squamous state on hair/ scalp and liable to interfere with the study assessments:

• alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis)
• raised skin lesion, likely to be traumatized, …
• Subject having dermatological pathology or evolutive skin lesion on the scalp (contact dermatitis, psoriasis, severe excoriations, severe sunburn, cutaneous bacterial superinfection of the scalp clinically obvious ...)
• Topical treatment or product applied on the scalp within 2 weeks before the inclusion or planned during the study that can be active on squamous states or that can limit the effectiveness of the study product: anti-inflammatory drugs, ketoconazole, anti-dandruff shampoo, anti-fungal, rinse with vinegar, essential oils ...
• Any scalp dyeing (including henna), bleaching, perm, smoothing / straightening performed within 3 weeks before inclusion or planned during the study
• Any topical hair product (conditioner, serum, mask, gel, lacquer, wax, foam…) or water applied on the scalp between the last shampoo and the inclusion visit