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

BioPharmX, Inc.20 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acne Vulgaris

Interventions

MinocyclineDRUG

BPX-01 1 or 2% topical gel will be applied to face once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (2)

Study Center

Coral Gables, Florida, United States

Study Center

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Change From Baseline in Inflammatory Lesion Counts at Week 12

difference in number of inflammatory lesions at week 12 as compared to baseline

Time frame: 12 weeks

Data from ClinicalTrials.gov

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