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

Acne Vulgaris Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Acne Vulgaris

• NCT number: NCT02815332
• Study type: Interventional
• Source: BioPharmX, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Completion date: March 24, 2017