Dermal Cumulative Irritant Patch Study

Vyne Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FMX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04064125

FX2016-08

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

FMX-101

Experimental group

Treatment:

Drug: FMX-101