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.

Study Overview

• Status: Completed
• Conditions: Seborrheic Dermatitis
• Intervention / Treatment: Other: RV5263A - WS0060; Other: RV5263A - LC3302; Drug: Standard Medical Care (SMC)

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poland
    • Malbork, Poland, Poland, 82200
      • Dr. E.Karamon Private Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test group	Other: RV5263A - WS0060; Cosmetic product Thrice weekly applications
Other: Comparative group	Other: RV5263A - LC3302; Cosmetic product Thrice weekly applications
Active Comparator: Standard medical care group	Drug: Standard Medical Care (SMC); Standard medical care applications

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dandruff severity (Squire score) after 29 days of product application	Dandruff severity (Squire score): clinical scoring (from 0 to 80) performed by the investigator	Visit 1 (Day 1) and Visit 6 (Day 29 or early termination).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	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	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.	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	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	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	Visit 1 (Day 1), Visit 2 (Day 4), Visit 3 (Day 7) and Visit 4 (Day 15)
Scalp proteic markers	via cotton-swab sampling	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	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	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)

Collaborators and Investigators

• Sponsor: Pierre Fabre Dermo Cosmetique

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2025
• Primary Completion (Actual): June 17, 2025
• Study Completion (Actual): June 17, 2025

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: seborrheic dermatitis; biological; standard medical care; samples; shampoo; squamous states; squire score; cosmetic product
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Skin and Connective Tissue Diseases; Dermatitis, Seborrheic
• Other Study ID Numbers: RV5263A20240639

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No