A Phase 1 interventional study of Tazarotene and Tazaroc Gel in Acne Vulgaris, sponsored by Stiefel, a GSK Company. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2017-06-23.
Sponsored by Stiefel, a GSK Company · Phase 1, Interventional, and Basic science
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.
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's enrollment of 30 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Stiefel, a GSK Company is the lead sponsor of 55 studies on the registry; none are open to participants now.
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Women who are not currently sexually active must agree to use medically accepted methods of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.
Exclusion Criteria:
Tazarotene foam 0.1%
Drug: Tazarotene
Tazaroc Gel 0.1%
Drug: Tazaroc Gel
Topical Tazarotene foam applied daily for 22 days.
Also known as: Tazorac
Topical tazarotene gel applied daily for 22 days.
Also known as: Tazorac
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
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Stiefel, a GSK Company