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A Study to Evaluate the Potential of Tazarotene Foam to Cause an Allergic Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers.

2014-08-27 03:13:52 | BioPortfolio

Summary

The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a photoallergic reaction when exposed to UV and VIS light on skin of healthy volunteers.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Conditions

Healthy

Intervention

Tazarotene (Patch application in Challenge Phase)

Location

HillTop Research Corporation
St. Petersburg
Florida
United States
33710

Status

Recruiting

Source

Stiefel, a GSK Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:52-0400

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