Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States (NCT06578962) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of a Cosmetic Shampoo RV3438G in Reccurent Squamous States
France63 participantsStarted 2020-11-09
Plain-language 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 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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
What they're measuring
1
Efficacy of the test product RV3438G during the maintenance phase by the global evolution of the squamous state assessed by the investigator
Timeframe: Assessed after 8 weeks of use, during the maintenance phase