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A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Safety and Therapeutic Equivalence of a Generic Tazarotene Foam 0.1%(Actavis) and the Reference Listed Fabior™(Tazarotene Foam, 0.1%) (Stiefel Laboratories, Inc.) in Treatment of Subjects With Acne Vulgaris
The purpose of this study is to compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris.
Details
| Lead sponsor | Actavis Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 893 |
| Start date | 2014-06 |
| Completion | 2014-09 |
Conditions
- Acne Vulgaris
Interventions
- Tazarotene (Fabior™)
- Tazarotene (Actavis)
- Vehicle foam
Primary outcomes
- Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts — Mean percent change from baseline to Week 12
For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e., the lines around the nostrils and under the nostrils) and all mucus membranes. - Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts — Mean percent change from baseline to Week 12
Estimates of mean percent change from baseline for non-inflammatory lesions for the Test and Reference treatment.
Countries
United States, Belize