Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States

Pierre Fabre

Status

Completed

Conditions

Dermatitis, Seborrheic

Treatments

Other: Phase 1: short intensive treatment phase

Other: Phase 2 : Tested product RV3438G associated with neutral shampoo

Other: Phase 2 : neutral shampoo

Other: Phase 2 : Tested product RV3438G associated with gentle balancing shampoo

Study type

Observational

Funder types

Industry

Identifiers

NCT06578962

RV3438G2020043

Details and patient eligibility

About

The aim of the study is to evaluate, with clinical, biological and biometrological assessment methods, the effectiveness of RV3438G shampoo, after 2 weeks of short intensive treatment phase and also the effects of a maintenance phase of 8 weeks in association with a neutral shampoo, or with a gentle balancing shampoo, compared to a neutral shampoo used single.

This is a bicentric, comparative (during the maintenance phase), randomized, controlled and open study, in parallel groups conducted in subjects having mild to moderate recurrent squamous states, for 10 weeks.

4 visits are planned. The maximum duration of the study is 74 days from inclusion visit to the End-of-study visit.

The study area is the whole scalp.

Full description

4 visits are performed: Visit 1: Inclusion (Day1) : start of the short intensive treatment phase (phase 1) Visit 2: Intermediate visit (Day15 ± 3 days, Week 2) : end of the short treatment intensive phase and start of the maintenance phase (phase 2) Visit 3: Intermediate visit (Day 43 ± 3 days, Week 6) : middle of the maintenance phase Visit 4: End-of-study visit (Day 71 ± 3 days, Week 10) : end of the maintenance phase

Enrollment

63 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Criteria related to the population:

Subject aged between 18 and 60 years included

Criteria related to the disease:

Subject having a squamous state of the scalp :

clinically visible (Squire score ≥ 20),
with an intensity of the squamous state superior or equal to 2 on a scale from 0 to 3 on at - least 1 of the 4 scalp areas
recurrent (at least twice a year)
associated to erythema and pruritus: erythema scoring superior or equal to 1 on a scale from 0 to 3 on at least 1 scalp area desquamating of the 4 scalp areas pruritus scoring assessed by the subject superior or equal to 3 on a numerical scale from 0 to 10 (mean pruritus felt on the last 3 days)

Exclusion criteria

Criteria related to the diseases / skin condition:

Subject having frizzy hair
Subject with an alopecia having caused hair loss on the upper part of the scalp (Norwood Hamilton stage> III, Ludwig ≥ I-4, alopecia aerata, alopecia totalis), Seborrheic dermatitis requiring medical treatment

Criteria related to treatments and/or products:

Systemic treatment with nonsteroidal anti-inflammatory, corticosteroid, antibiotic, antihistamine taken during 5 consecutive days within the 2 weeks before the inclusion or planned during the study and liable to interfere with the study assessments
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, bleaching, perm, smoothing / straightening performed within 2 weeks before inclusion