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 (OPAL)

NCT02815332 Phase 2 COMPLETED

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.

Details

Lead sponsor	BioPharmX, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	225
Start date	2016-08
Completion	2017-03-24

Conditions

• Acne Vulgaris

Interventions

• BPX-01 1% Minocycline Topical Gel
• BPX-01 2% Minocycline Topical Gel
• BPX-01 Vehicle Topical Gel

Primary outcomes

• Change in inflammatory lesion counts — 12 weeks
  Absolute mean change from baseline in inflammatory lesion counts

Countries

United States