At a glance
ClinicalIndex Comparison RecordN/ACompleted· 50 enrolled
Drug / intervention
Test Product +3 moreother
Likely dose
Micellar cleanser 0.09 ml applied topicallyAI-extracted
Key inclusion· 5
- ✓Age 18-65 years inclusive
- ✓Fitzpatrick phototype I to IV
- ✓Intact skin at the volar forearm with no baseline dryness or redness
- ✓Free of clinically relevant dermatological conditions per dermatologist assessment
Key exclusion· 9
- ✕History of significant dermatological diseases or conditions (e.g., atopic dermatitis, dermatographism)
- ✕Active dermatosis (local or disseminated)
- ✕Open sores, pimples, or cysts at the application site
- ✕Immunocompromised status
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study to Assess the Mildness of a Cosmetic Cleanser in Healthy Subjects Using the Forearm-Controlled Application Technique (FCAT)
In Brief
A clinical study evaluating Test Product, Positive Control, and 2 other interventions for Skin Care. Completed, enrolled 50 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSkin Care
CountriesBrazil
Collaborators--
Timeline
N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionMay 2017
TodayJul 2026
First PostedApr 18, 2017
Enrollment StartMay 8, 2017
Primary CompletionMay 26, 2017
TodayJul 2, 2026
Enrollment to primary: 18 daysPosted 9.2 years ago
Interventions
Test Productother
Micellar cleanser (0.09 ml)
Positive Controlother
Bar Soap (rubbed for 6 seconds to generate a lather)
Reference Productother
Sterile Water (0.09 ml)
No Treatmentother
Unwashed area of the forearm