NCT01019603

A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris

A Single-Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess systemic exposure of a new foam formulation of tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are based on previous clinical studies with Tazorac Gel and Tazorac Cream.

Detailed description

A single-center, randomized, open-label, phase 1, comparative bioavailability study in subjects with moderate to severe acne vulgaris. Approximately 30 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: Tazorac Gel). Study product will be applied once daily for 22 days to the face, upper chest, upper back, and shoulders. Following the baseline visit, subjects will return to the study center daily for study product application. Blood samples to determine plasma concentrations of tazarotenic acid will be collected before study product application on days 1, 8, 12, 15, 18, 20, and 22, and collected at multiple time points over a 72 hour period on days 22 through 25.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tazarotene	Topical Tazarotene foam applied daily for 22 days.
DRUG	Tazaroc Gel	Topical tazarotene gel applied daily for 22 days.

Timeline

• Start date: 2009-10-12
• Primary completion: 2009-12-20
• Completion: 2009-12-20
• First posted: 2009-11-25
• Last updated: 2017-06-23

Locations

1 site across 1 country: United States