Conditions: Acne Vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 893
Healthy volunteers: no

Brief summary:
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.

Detailed description:
Although topical retinoids have been individually used to successfully treat acne vulgaris, Fabior™ (Tazarotene) Foam, 0.1% is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis has developed a generic formulation of Tazarotene Foam, 0.1%, and the current study is designed to evaluate the safety and efficacy of this formulation.

Arms:
arm 1: Reference listed drug: Fabior™ 0.1% foam (Stiefel) arm 2: Tazarotene 0/1% foam (Actavis) arm 3: Foam vehicle of the test product (Actavis)

Interventions: intervention 1: Tazarotene (Fabior™) intervention 2: Tazarotene (Actavis) intervention 3: Vehicle foam
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: