An interventional study of RV5263A - WS0060 and RV5263A - LC3302 in Seborrheic Dermatitis, sponsored by Pierre Fabre Dermo Cosmetique. Completed at 1 site in Poland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Pierre Fabre Dermo Cosmetique · Not applicable, Interventional, and Supportive care
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:
Standard medical care group
6 visits are planned:
53 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 44 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →Pierre Fabre Dermo Cosmetique is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Subject having a squamous state of the scalp:
Non Inclusion criteria
Subject having any other dermatologic condition than the studied squamous state on hair/ scalp and liable to interfere with the study assessments:
Other: RV5263A - WS0060
Other: RV5263A - LC3302
Drug: Standard Medical Care (SMC)
Cosmetic product Thrice weekly applications
Cosmetic product Thrice weekly applications
Standard medical care applications
Dandruff severity (Squire score) after 29 days of product application
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
Time frame: Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).
Dandruff severity (Squire score) after 4, 7, 15 and 22 days of product application
Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator
Time frame: 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
Intensity of the squamous state on a 4-point scale (from 0 to 3), performed by the investigator
Time frame: 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)
Erythema score on a 4-point scale (from 0 to 3), performed by the investigator
Time frame: 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)
Mean pruritus felt on the last 3 days on a NRS (0-10), performed by the subject
Time frame: 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)
Burning sensation score, on a NRS (0-10), performed by the subject
Time frame: 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)
Immediate pruritus felt, on a NRS (0-10), performed by the subject
Time frame: Immediately after the 1st application of product
Immediate irritation state score (burning sensation)
Immediate burning sensation score, on a NRS (0-10), performed by the subject
Time frame: Immediately after the 1st application of product
Investigator Global Assessment
Investigator Global Assessment, on a 5-point scale (from 1 to 5), performed by the investigator
Time frame: 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
Subject Global Assessment, on a 5-point scale (from 1 to 5), performed by the subject
Time frame: 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)
Squamous state (dandruff) score, on a 4-point scale, (from 0 to 3), performed by the subject
Time frame: 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
Discomfort evolution, on a 4-point scale (from 0 to 3), performed by the subject
Time frame: 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
Scalpdex questionnaire, completed by the subject
Time frame: Visit 1 (Day 1), Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
Quality of life, Chronic Itch Burden scale
Chronic Itch Burden questionnaire, completed by the subject
Time frame: 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
Acceptability questionnaire regarding the use of the product will be completed by the subject.
Time frame: Immediately after the 1st application, Visit 4 (Day 15) and Visit 6 (Day 29 or early termination)
Recording of adverse events
Adverse events occurrence will be determined by the subject spontaneous reporting, the investigator's non-leading questioning and his/her clinical evaluation
Time frame: From Visit 1 (Day 1) to Visit 6 (Day 29 or early termination)
Illustration of subject's squamous state evolution
Standardized photographs of the subject's scalp of affected area for illustrative purpose only
Time frame: 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
Via cotton-swab sampling
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
Scalp proteic markers
via cotton-swab sampling
Time frame: Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
Molecular characterization of the scalp sebum
via cigarette paper sampling
Time frame: 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
via cigarette paper sampling
Time frame: 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)
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Pierre Fabre Dermo Cosmetique