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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-13

Study Completion Date

2018-06-01

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.

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BPX-01 1%

BPX-01 1% minocycline topical gel

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

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

BPX-01 2%

BPX-01 2% minocycline topical gel

Group Type EXPERIMENTAL

Minocycline

Intervention Type DRUG

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

Interventions

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Minocycline

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

Intervention Type DRUG

Other Intervention Names

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BPX-01

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No