BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris
Public ClinicalTrials.gov record NCT02815332. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Vehicle Controlled Study to Assess the Safety and Efficacy of BPX-01 Minocycline Topical Gel in the Treatment of Moderate to Severe Inflammatory Acne Vulgaris
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 12-week, multi-center, double-blind, randomized, three-arm, vehicle-controlled study. Subjects will be randomized (1:1:1) to 1% or 2 % BPX-01 gel, or vehicle. 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. Blood draws will be collected at baseline (Day 0), and at Weeks 4 and 12 to evaluate the level of minocycline in plasma. 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, and collection of adverse events.
Study identification
- NCT ID
- NCT02815332
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Interventions
- BPX-01 1% Minocycline Topical Gel Drug
- BPX-01 2% Minocycline Topical Gel Drug
- BPX-01 Vehicle Topical Gel Drug
Drug
Eligibility (public fields only)
- Age range
- 9 Years to 40 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2016
- Primary completion
- Mar 23, 2017
- Completion
- Mar 23, 2017
- Last update posted
- Apr 13, 2017
2016 – 2017
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Santa Monica | California | — | — |
| Not listed | Coral Gables | Florida | — | — |
| Not listed | Lake Mary | Florida | — | — |
| Not listed | Newnan | Georgia | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | Las Vegas | Nevada | — | — |
| Not listed | Montclair | New Jersey | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Highpoint | North Carolina | — | — |
| Not listed | Murfreesboro | Tennessee | — | — |
| Not listed | Nashville | Tennessee | — | — |
| Not listed | Pflugerville | Texas | — | — |
| Not listed | Plano | Texas | — | — |
| Not listed | San Antonio | Texas | — | — |
| Not listed | Spokane | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02815332, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2017 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02815332 live on ClinicalTrials.gov.