A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||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|
- Plasma concentrations of tazarotenic acid in subjects with acne vulgaris [ Time Frame: Days 1, 8, 12, 15, 18, 20, 22 (pre-dose and 3, 4.5, 6, 7.5, 9, 12, 16, 20, 24, 38, 48, 62, and 72 hr post-dose ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||January 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Tazarotene foam 0.1%
Topical Tazarotene foam applied daily for 22 days.
Other Name: Tazorac
Active Comparator: 2
Tazaroc Gel 0.1%
Drug: Tazaroc Gel
Topical tazarotene gel applied daily for 22 days.
Other Name: Tazorac
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.