Dermal Cumulative Irritant Patch Study

• Sponsor: Vyne Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04064125
• Collaborator: (none)
• Enrollment: 42
• Arm: 1
• Actual Duration (Months): 1.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: FMX-101	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Sep 28, 2016
• Actual Study Completion Date: Oct 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FMX-101	Drug: FMX-101

Outcome Measures

Primary Outcome Measures

1. Comparison of mean cumulative irritation over time for IP versus controls using a dermal irritation numerical equivalent grading tool. [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Vyne Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vyne Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT04064125
• Other Study ID Numbers: FX2016-08
• First Posted: Aug 21, 2019
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Minocycline

Study Results

No Results Posted as of Aug 28, 2019