NCT02815332

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

A 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: BioPharmX, Inc. · Industry
• Sex: All
• Age: 9 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled study. Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy. Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the level of minocycline in plasma. Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and collection of adverse events.

Detailed description

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

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	BPX-01 1% Minocycline Topical Gel	Approximately 1 gram applied once daily for 12 weeks
DRUG	BPX-01 2% Minocycline Topical Gel	Approximately 1 gram applied once daily for 12 weeks
DRUG	BPX-01 Vehicle Topical Gel	Approximately 1 gram applied once daily for 12 weeks

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-03-24
• Completion: 2017-03-24
• First posted: 2016-06-28
• Last updated: 2017-04-14

Locations

15 sites across 1 country: United States