Dermal Cumulative Irritant Patch Study
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: FMX-101
- Registration Number
- NCT04064125
- Lead Sponsor
- Vyne Therapeutics Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- 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.
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Exclusion Criteria
- 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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMX-101 FMX-101 -
- Primary Outcome Measures
Name Time Method Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool. 3 weeks
- Secondary Outcome Measures
Name Time Method