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

Pierre Fabre Dermo Cosmetique90 enrolled

Overview

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: * 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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Seborrheic Dermatitis

Interventions

RV5263A - WS0060OTHER

Cosmetic product Thrice weekly applications

RV5263A - LC3302OTHER

Cosmetic product Thrice weekly applications

Standard Medical Care (SMC)DRUG

Standard medical care applications

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr. E.Karamon Private Practice

Malbork, Poland, Poland

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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