Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:35 PM
Ignite Modification Date:
2025-12-24 @ 9:35 PM
NCT ID:
NCT02815332
Brief 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
Study:
NCT02815332
Study Brief:
Protocol Section:
NCT02815332