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

Study Timeline

• Study Start: 2016-08-17
• Primary Completion: 2016-09-07
• Study Completion: 2016-10-01
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-26
• Study First Posted: 2019-08-28
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Healthy male or female volunteers age 18 years or older
2. 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

Exclusion Criteria

1. 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
2. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study

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