Efficacy of Cosmetic Product RV3278B-OS0386 on Skin Surface Ecosystem, in Teenagers with Mild to … (NCT06659861) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Cosmetic Product RV3278B-OS0386 on Skin Surface Ecosystem, in Teenagers with Mild to Moderate Facial Acne
Romania52 participantsStarted 2024-10-10
Plain-language summary
The aim of this exploratory study is to better understand the mechanisms of action of the RV3278B-OS0386 cosmetic product on the cutaneous ecosystem, in acne context.
Who can participate
Age range
12 Years – 17 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:
* Female and male aged between 12 and 17 years included
* Subject having signed his/her written informed consent/assent for his/her participation in the study
* Subject whose parent(s) or guardian(s) has (have) given his/her (their) written consent for their child's participation in the study
* Subject affiliated to a social security system or health insurance, or is a beneficiary
* Subject whose parent(s) or guardian(s) is (are) registered with health social security or health insurance
* Subject and/or parents certifying the truth of the personal information declared to the investigator
* Cooperative subject and/or parent(s)/legal representative(s), aware of the necessity and duration of controls so that perfect adhesion to the protocol established by the clinical trial centre could be expected
* Subject with phototype I, II, III, IV according to the Fitzpatrick scale
* For woman/girl of childbearing potential:
* use of an effective method of contraception, as assessed by the investigator, introduced and unchanged for at least 1 month (3 months in case of hormonal contraception) before inclusion in the study
* accept to go on using it during the whole duration of the study
Criteria related to the skin condition (acne):
* Subject with combination, combination to greasy skin tendency or oily skin on face
* Subject with mild to moderate acne vulgaris on face; GEA from 2 to 3
* Subject with predominantly non-infla…
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
Effect of the RV3278B on acne severity
Timeframe: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
2
Effect of the RV3278B on open comedones.
Timeframe: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
3
Effect of the RV3278B on biological criteria within isolated comedones
Timeframe: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
4
Effect of the RV3278B on biological criteria from the skin surface
Timeframe: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
5
Effect of the RV3278B on biometrological criteria
Timeframe: Change from Visit 1 (Day 1) to Visit 3 (Day 57).
6
Adverse events related to RV3278B
Timeframe: From Visit 1 (Day 1) to Visit 3 (Day 57)