NCT02709096

BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: BioPharmX, Inc. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate the comparative reduction of Propionibacterium acnes in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.

Detailed description

The objective of this study is to evaluate the comparative reduction of Propionibacterium acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel or BPX-01 Vehicle control Gel. A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline are also of significant interest to the sponsor. This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as a topical gel once daily for four (4) weeks. This is a six (6) week study with a four (4) week treatment period and a two (2) week post treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and basic hematology and chemistry laboratory values will be collected.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	BPX-01, 1% Topical Gel	topical gel, applied to the forehead, cheeks, nose and chin
DRUG	BPX-01 Vehicle Gel	topical gel, applied to the forehead, cheeks, nose and chin

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-03-15
• Last updated: 2017-09-14
• Results posted: 2017-09-14

Locations

1 site across 1 country: United States