NCT02946788

Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel

An Open Label Study to Document the Treatment Effect of 1 and 2% BPX-01 Minocycline Topical Gel in Moderate to Severe Inflammatory Non-nodular Acne Vulgaris (Protocol Number BPX-01-C04)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: BioPharmX, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.

Detailed description

This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. 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. Photographs will be taken to document treatment effect. 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, incidence of product related facial staining and collection of adverse events.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Minocycline	BPX-01 1 or 2% topical gel will be applied to face once daily

Timeline

• Start date: 2017-03-13
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2016-10-27
• Last updated: 2022-07-26
• Results posted: 2022-07-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study