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

Phase 2

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Minocycline

• Registration Number: NCT02946788
• Lead Sponsor: BioPharmX, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-27
• Study Start: 2017-03-13
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2022-07
• Results First Submitted: 2022-07-03
• Results First Submitted QC: 2022-07-03
• Last Update Submitted: 2022-07-03
• Results First Posted: 2022-07-26
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• moderate to severe inflammatory non-nodular acne vulgaris

Exclusion Criteria

• female subject who is breastfeeding, pregnant or planning a pregnancy during the study
• have other skin condition or disease that would interfere with the study
• have had any prior treatment with minocycline
• have a known or suspected allergy to tetracycline class products
• have used OTC medications for the treatment of facial acne within the last 14 days
• have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days
• have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BPX-01 2%	Minocycline	BPX-01 2% minocycline topical gel
BPX-01 1%	Minocycline	BPX-01 1% minocycline topical gel

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Inflammatory Lesion Counts at Week 12	12 weeks	difference in number of inflammatory lesions at week 12 as compared to baseline

Trial Locations

Locations (1)

Study Center; 🇺🇸 Las Vegas, Nevada, United States