NCT01119651

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.

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (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 photoallergic 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 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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tazarotene (Patch application in Challenge Phase)	There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated \& will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E.

Timeline

• Start date: 2010-06-14
• Primary completion: 2010-06-26
• Completion: 2010-06-26
• First posted: 2010-05-07
• Last updated: 2017-06-14

Locations

1 site across 1 country: United States