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

2014-08-27 03:14:00 | BioPortfolio

Summary

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.

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 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.

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 without irradiation, Tazarotene Foam with UVA and UVB irradiation, Tazarotene Foam with UVA, UVB, and visible light, Vehicle Foam without irradiation, Vehicle Foam with UVA and UVB irradiation, Vehicle Foam with UVA and UVB and visible lig

Location

HillTop Research Corporation
Scottsdale
Arizona
United States
85251

Status

Active, not recruiting

Source

Stiefel, a GSK Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:00-0400

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PubMed Articles [1352 Associated PubMed Articles listed on BioPortfolio]

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Tazarotene gel with narrow-band UVB phototherapy: a synergistic combination in psoriasis.

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Medical and Biotech [MESH] Definitions

Irradiation of one half or both halves of the body in the treatment of disseminated cancer or widespread metastases. It is used to treat diffuse metastases in one session as opposed to multiple fields over an extended period. The more frequent treatment modalities are upper hemibody irradiation (UHBI) or lower hemibody irradiation (LHBI). Less common is mid-body irradiation (MBI). In the treatment of both halves of the body sequentially, hemibody irradiation permits radiotherapy of the whole body with larger doses of radiation than could be accomplished with WHOLE-BODY IRRADIATION. It is sometimes called "systemic" hemibody irradiation with reference to its use in widespread cancer or metastases. (P. Rubin et al. Cancer, Vol 55, p2210, 1985)

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