Status:
COMPLETED
Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States
Lead Sponsor:
Pierre Fabre Dermo Cosmetique
Conditions:
Dermatitis, Seborrheic
Eligibility:
All Genders
18-60 years
Brief Summary
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 t...
Detailed 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 p...
Eligibility Criteria
Inclusion
- 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 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
Key Trial Info
Start Date :
November 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 11 2021
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT06578962
Start Date
November 9 2020
End Date
May 11 2021
Last Update
August 30 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre de Santé Sabouraud - Hôpital Saint Louis
Paris, France, 75010