Dermal Cumulative Irritant Patch Study

Vyne Therapeutics Inc.42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

FMX-101DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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.

Outcomes

Primary Outcomes

Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool.

Time frame: 3 weeks

Data from ClinicalTrials.gov

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