To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlle… (NCT03119688) | Clinical Trial Compass
CompletedNot Applicable
To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT)
Brazil50 participantsStarted 2017-05-08
Plain-language summary
The objective of this clinical study is to assess the relative mildness of a cosmetic facial cleanser in comparison to water through repeated application to the volar forearm using the FCAT wash procedure.
Who can participate
Age range
18 Years – 65 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:
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* Aged between 18 and 65 years inclusive.
* Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination.
* Intact skin at the proposed application site; volar forearm.
* Clinical assessment for eligibility by a dermatologist to ensure participant is free of clinically relevant dermatological conditions.
* Fitzpatrick phototype I to IV.
* Trained examiner scores of zero for dryness and redness for each volar forearm at Screening visit (Visit 1) and each allocated test site on each forearm at Baseline visit.
* Agreement to comply with the procedures and requirements of the study and to attend the scheduled assessment visits.
Exclusion Criteria:
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
* Women who are breast-feeding
* Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test s…
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
Change From Baseline in Visual Assessment of Dryness at Day 5
Timeframe: At Baseline and Day 5 (3 hours post last wash procedure)