BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris

This is a phase 2b, randomized, double-blind, vehicle-controlled study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris. Study Population: Approximately 225 male or female subjects aged between 9 and 40 years with moderate to severe inflammatory non-nodular acne vulgaris will be included in this study. Number of Sites: Approximately 15 centers from the United States will participate in this study. Study Duration: Overall study duration is expected to be approximately 24 weeks (6 months). The study duration for individual subjects is approximately 16 weeks (including the screening period). Hypothesis: BPX-01 improves disease condition in subjects with moderate to severe inflammatory non-nodular acne vulgaris compared with vehicle. Objectives: Primary: * To evaluate the efficacy of BPX-01 minocycline 1% or 2% topical gel in the treatment of inflammatory non-nodular acne vulgaris Secondary: * To evaluate the plasma level of minocycline after once daily application of 1% or 2% BPX 01 topical gel * To evaluate the safety of BPX-01 minocycline 1% or 2% topical gel Endpoints: Primary Efficacy Endpoint: * Absolute mean change from baseline in inflammatory lesion counts at Week 12 Secondary Efficacy Endpoint: * Proportion of subjects with at least a two-grade reduction in IGA at Week 12