A 4-weeks Comparative Study of Cosmetic Product Versus Standard Medical Care in Subjects With Seborrheic Dermatitis

NCT07576023 | Completed

• 1 other identifier: RV5263A20240639
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Seborrheic Dermatitis

Keywords

seborrheic dermatitis; shampoo; squamous states; squire score; biological; samples; standard medical care; cosmetic product

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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 (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 (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 (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)

Study Arms (3)

Test group

EXPERIMENTAL

Other: RV5263A - WS0060

Comparative group

OTHER

Other: RV5263A - LC3302

Standard medical care group

ACTIVE COMPARATOR

Drug: Standard Medical Care (SMC)

Interventions

RV5263A - WS0060 OTHER

Cosmetic product Thrice weekly applications

Test group

RV5263A - LC3302 OTHER

Cosmetic product Thrice weekly applications

Comparative group

Standard Medical Care (SMC) DRUG

Standard medical care applications

Standard medical care group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 ...)

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Dr. E.Karamon Private Practice

Malbork, Poland, 82200, Poland

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: February 4, 2025
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

PL (1)