A 4-weeks Comparative Study of Cosmetic Product Versus Standard Medical Care in Subjects With Seb… (NCT07576023) | Clinical Trial Compass
CompletedNot Applicable
A 4-weeks Comparative Study of Cosmetic Product Versus Standard Medical Care in Subjects With Seborrheic Dermatitis
Poland90 participantsStarted 2025-02-04
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Dandruff severity (Squire score) after 29 days of product application
Timeframe: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).