Dermal Phototoxicity Study

Phase 1CompletedNCT04070742

Vyne Therapeutics Inc.32 enrolled

Overview

Dermal Safety study to determine the Phototoxicity Potential of FMX-101 4% in Healthy Volunteers

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

FMX101DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score

Time frame: 4 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.