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A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers

2014-08-27 03:14:01 | BioPortfolio

Summary

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.

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 contact sensitization following repeated exposure under maximal stress conditions in healthy adult volunteers. Approximately 240 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.

All subjects will be exposed to patches containing tazarotene foam and vehicle foam. Inflammatory skin responses (eg, erythema, edema, papules) or superficial effects at patch sites will be visually assessed and scored according to the corresponding grading scales.

The study duration will be 6 weeks or 9 weeks and will consist of the following phases: 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 Foam, Vehicle Foam

Location

HillTop Research Corporation
Scottsdale
Arizona
United States
85251

Status

Recruiting

Source

Stiefel, a GSK Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:01-0400

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