Dermal Photo Allergic Skin Reaction

Vyne Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FMX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04070755

FX2016-09

Details and patient eligibility

About

A 6-Week, Randomized Study to Evaluate the Potential of FMX-101, 4% And Vehicle to Induce a Photo Allergic Skin Reaction in Healthy Volunteers, Using a Controlled Photo Patch Test Design

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female who were 18 years of age or older
• Had 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

• 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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56 participants in 1 patient group

FMX-101

Experimental group

Treatment:

Drug: FMX-101