Status:
COMPLETED
Dermal Cumulative Irritant Patch Study
Lead Sponsor:
Vyne Therapeutics Inc.
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A 21-Day, Randomized, Controlled Study to Evaluate the Skin Irritation Potential of FMX-101 in Healthy Volunteers Using a Cumulative Irritant Patch Test Design
Eligibility Criteria
Inclusion
- Healthy males or females who were 18 years of age or older.
- Were of any Fitzpatrick Skin Type or race, providing the skin pigmentation allowed for discernment of erythema.
Exclusion
- Had any visible skin disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction.
- Had damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2016
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04064125
Start Date
September 1 2016
End Date
October 28 2016
Last Update
August 28 2019
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