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 range
18 Years – 60 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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