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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Minocycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BPX-01 1%<br>BPX-01 1% minocycline topical gel | Drug: Minocycline<br>* BPX-01 1 or 2% topical gel will be applied to face once daily<br>* Other names: BPX-01;|
| Experimental: BPX-01 2%<br>BPX-01 2% minocycline topical gel | Drug: Minocycline<br>* BPX-01 1 or 2% topical gel will be applied to face once daily<br>* Other names: BPX-01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Inflammatory Lesion Counts at Week 12 | difference in number of inflammatory lesions at week 12 as compared to baseline | 12 weeks |