Acne Vulgaris Clinical Trial
Official title:
A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled Study To Evaluate The Phototoxic Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a phototoxic reaction when exposed to UV and VIS light on skin of healthy volunteers.
This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to
evaluate the potential of Tazarotene Foam 0.1% to induce a phototoxic reaction in healthy
adult volunteers. Approximately 40 healthy, male and female, volunteer subjects aged 18 to
65 years will be enrolled.
Each subject will be exposed to three (3) sets of three (3) patches containing Tazarotene
Foam, Vehicle Foam and a Blank Patch (no study product). Each patch set will be applied to
randomized sites on the subject's back. Patch sets will be removed and evaluated after 24
hours of exposure. The exposed patch sites will then be irradiated (exposed to light) and
evaluated at 1 hour post irradiation and at 24, 48, and 72 hours.
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