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 range

18 Years – 70 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dandruff severity (Squire score) after 29 days of product application

Timeframe: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).

Trial details

NCT IDNCT07576023

SponsorPierre Fabre Dermo Cosmetique

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-17

View on ClinicalTrials.gov More Seborrheic Dermatitis trials