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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 photoallergic reaction in healthy adult volunteers. Approximately 62 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.
All subjects will be exposed to patches containing tazarotene foam, vehicle foam, and no foam (blank; negative control). Inflammatory skin responses (eg, erythema and local skin reactions) or superficial effects at patch sites will be visually assessed to corresponding grading scales. The study duration will be 6 weeks or 9 weeks and will consist of the following phases: Screening, 3 week Induction, 2 week Rest, and 1 week Challenge, and if indicated, a second 2 week Rest and 1 week Repeat Challenge.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
Tazarotene (Patch application in Challenge Phase)
HillTop Research Corporation
Stiefel, a GSK Company
Published on BioPortfolio: 2014-08-27T03:13:52-0400
This study will assess the potential of tazarotene foam to cause sensitization during a 48 hour challenge following 21 days of exposure on the skin of healthy volunteers.
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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.
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A medicated adhesive patch placed on the skin to deliver a specific dose of medication into the bloodstream.
Human experimentation that is not intended to benefit the subjects on whom it is performed. Phase I drug studies (CLINICAL TRIALS, PHASE I AS TOPIC) and research involving healthy volunteers are examples of nontherapeutic human experimentation.
Skin tests in which the sensitizer is applied to a patch of cotton cloth or gauze held in place for approximately 48-72 hours. It is used for the elicitation of a contact hypersensitivity reaction.
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