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NCT02815332 · ClinicalTrials.gov registry record · Phase 2
BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris
A Phase 2 study of Acne Vulgaris, sponsored by BioPharmX.
- Completed
- Registry status
- Phase 2
- Development phase
- 225
- Enrollment target
- 15
- Study locations
NCT02815332: Completed Phase 2 study of Acne Vulgaris, sponsored by BioPharmX.
NCT02815332 is a Phase 2 study of Acne Vulgaris that has completed, run by BioPharmX. The registered enrollment target is 225 participants, below the 272-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (17% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02815332, a Phase 2 study of Acne Vulgaris, has completed, sponsored by BioPharmX.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 225 participants
- Enrollment target
- 15
- Study locations
Study Summary
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.
Primary Outcome
Absolute mean change from baseline in inflammatory lesion counts
Conditions Studied
Interventions
- DRUG BPX-01 1% Minocycline Topical Gel
- DRUG BPX-01 2% Minocycline Topical Gel
- DRUG BPX-01 Vehicle Topical Gel
Study Locations (15)
Texas
- - Pflugerville
- - Plano
- - San Antonio
Florida
- - Coral Gables
- - Lake Mary
Tennessee
- - Murfreesboro
- - Nashville
California
- - Santa Monica
Georgia
- - Newnan
Kentucky
- - Louisville
Nevada
- - Las Vegas
New Jersey
- - Montclair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2016-08 |
| Est. Completion | 2017-03-24 |
| Phase | Phase 2 |
What the finished NCT02815332 record still lists
NCT02815332 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 272-participant average among 67 other Acne Vulgaris trials with a reported enrollment target (17% lower).
The record links to 1 condition, with Acne Vulgaris appearing as the primary indexed condition, and to 3 interventions - of which BPX-01 1% Minocycline Topical Gel is the first listed.
NCT02815332 lists 15 locations in 11 states (Texas, Florida, Tennessee).
Frequently Asked Questions
What is clinical trial NCT02815332 about?
NCT02815332 is a clinical study titled "BPX-01 Minocycline Topical Gel in the Treatment of Acne Vulgaris". 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. Le...
What is the current status of trial NCT02815332?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2016-08. Estimated completion is 2017-03-24.
What conditions does trial NCT02815332 study?
This clinical trial studies the following conditions: Acne Vulgaris.
What interventions are being tested in trial NCT02815332?
The interventions under investigation include: BPX-01 1% Minocycline Topical Gel (DRUG), BPX-01 2% Minocycline Topical Gel (DRUG), BPX-01 Vehicle Topical Gel (DRUG).
Who is sponsoring clinical trial NCT02815332?
This trial is sponsored by BioPharmX, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02815332 being conducted?
This trial has 15 study locations across California, Florida, Georgia, Kentucky, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02815332's enrollment target sits among peer trials
225 26th of 67 higher than 42 of 67 other Acne Vulgaris trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acne Vulgaris trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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