Dermal Photo Allergic Skin Reaction

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

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

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