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

A Randomized Comparative Study to Evaluate the Efficacy of the Shampoo RV5263A - WS0060 Applied for 4 Weeks in Adults Subjects With Recurrent Squamous States of Seborrheic Dermatitis in Comparison to Standard Medical Care and a Cosmetic Shampoo

The aim of this study is to evaluate, with clinical and biological assessment methods, the effectiveness of the tested cosmetic product applied during 4 weeks of intensive treatment and compared to a Standard Medical Care (medicine shampoo) and to a comparative cosmetic shampoo, on mild to moderate recurrent squamous states of 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