Dermal Phototoxicity Study
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: FMX101
- Registration Number
- NCT04070742
- Lead Sponsor
- Vyne Therapeutics Inc.
- Brief Summary
Dermal Safety study to determine the Phototoxicity Potential of FMX-101 4% in Healthy Volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Healthy male or female volunteers age 18 years or older
- Has uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II, or III
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Exclusion Criteria
- Has any visible disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction
- Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FMX-101 FMX101 -
- Primary Outcome Measures
Name Time Method Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score 4 days
- Secondary Outcome Measures
Name Time Method