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 range18 Years – 65 Years
SexALL
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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…
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)