NCT01115322

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

A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled Study To Evaluate The Phototoxic Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tazarotene Foam without irradiation	Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
DRUG	Tazarotene Foam with UVA and UVB irradiation	Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
DRUG	Tazarotene Foam with UVA, UVB, and visible light	Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
DRUG	Vehicle Foam without irradiation	Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
DRUG	Vehicle Foam with UVA and UVB irradiation	Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
DRUG	Vehicle Foam with UVA and UVB and visible light irradiation	Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
DRUG	No Treatment without irradiation	Each subject will be exposed to a blank patch during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
DRUG	No Treatment with UVA and UVB irradiation	Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
DRUG	No Treatment with UVA and UVB and visible light irradiation	Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-04-10
• Completion: 2010-04-10
• First posted: 2010-05-04
• Last updated: 2017-06-20

Locations

1 site across 1 country: United States