Dermal Phototoxicity Study

Vyne Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: FMX101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04070742

FX2016-06

Details and patient eligibility

About

Dermal Safety study to determine the Phototoxicity Potential of FMX-101 4% in Healthy Volunteers

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female volunteers age 18 years or older
2. Has 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

1. Has any visible disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction
2. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

FMX-101

Experimental group

Treatment:

Drug: FMX101