NCT07576023CompletedNot Applicable
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
Pierre Fabre Dermo Cosmetique1 site in 1 country90 target enrollmentStarted: February 4, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Dandruff severity (Squire score) after 29 days of product application
Study Overview
Brief 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.
Detailed Description
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
Test group
Experimental
Intervention: RV5263A - WS0060 (Other)
Comparative group
Other
Intervention: RV5263A - LC3302 (Other)
Standard medical care group
Active Comparator
Intervention: Standard Medical Care (SMC) (Drug)
Outcomes
Primary Outcomes
Dandruff severity (Squire score) after 29 days of product application
Time Frame: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
Secondary Outcomes
- Dandruff severity (Squire score) after 4, 7, 15 and 22 days of product application(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), and Visit 5 (Day 22))
- Intensity of squamous global state(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Irritation state score (pruritus)(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Irritation state score (erythema)(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Irritation state score (burning sensation)(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Immediate irritation state score (pruritus)(Immediately after the 1st application of product)
- Immediate irritation state score (burning sensation)(Immediately after the 1st application of product)
- Investigator Global Assessment(Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Subject Global Assessment(Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Evolution of squamous state (dandruff)(Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Evolution of discomfort(Visit 1 (Day 1), immediately after the 1st application, Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Quality of Life, specific scalp questionnaire(Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination))
- Quality of life, Chronic Itch Burden scale(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Acceptability Questionnaire assessment(Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination))
- Recording of adverse events(From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination))
- Illustration of subject's squamous state evolution(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Strains of the scalp microbiota(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15))
- Scalp proteic markers(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15))
- Molecular characterization of the scalp sebum(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
- Molecular characterization of the scalp - lipids(Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7), Visit 4 (Day 15), Visit 5 (Day 22) and Visit 6 (Day 29 or early termination))
Investigators
Study Sites (1)
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