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

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2016-09-28
• Study Completion: 2016-10-28
• Status Verified: 2019-08
• Study First Submitted: 2019-08-08
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

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.

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.

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