A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris
A Phase 3 Multi-Center, Randomized, Double-Blinded, Vehicle-Controlled, Parallel Group Study Comparing the Efficacy, Tolerability and Safety of SB204 and Vehicle Gel Once Daily in the Treatment of Acne Vulgaris
This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
This is a double-blind, placebo controlled study in subjects with moderate to severe acne. Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
Inclusion Criteria:
Exclusion Criteria: