BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): BPX-01 1% Minocycline Topical Gel; BPX-01 2% Minocycline Topical Gel; BPX-01 Vehicle Topical Gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Approximately 1 gram applied once daily for 12 weeks; Approximately 1 gram applied once daily for 12 weeks; Approximately 1 gram applied once daily for 12 weeks
Other intervention name(s): BPX-01 Topical Gel; BPX-01 Topical Gel; BPX-01 Vehicle Gel
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment