Conditions: Acne Vulgaris
Keywords: Ance
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 744
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

Detailed description:
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.

Arms:
arm 1: Tazarotene foam, 0.1% arm 2: Vehicle Foam

Interventions: intervention 1: Tazarotene foam intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: Tazarotene foam once a day application to the face intervention 2: Vehicle Foam once a day application to the face

Protocol document: