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

BioPharmX

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Minocycline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02946788

BPX-01-C04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

BPX-01 1%

Experimental group

Description:

BPX-01 1% minocycline topical gel

Treatment:

Drug: Minocycline

BPX-01 2%

Experimental group

Description:

BPX-01 2% minocycline topical gel

Treatment:

Drug: Minocycline