BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
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ClinicalTrials.gov Identifier: NCT02709096 |
Recruitment Status :
Completed
First Posted : March 15, 2016
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | March 10, 2016 | |||
First Posted Date ICMJE | March 15, 2016 | |||
Results First Submitted Date ICMJE | July 18, 2017 | |||
Results First Posted Date ICMJE | September 14, 2017 | |||
Last Update Posted Date | September 14, 2017 | |||
Study Start Date ICMJE | April 2016 | |||
Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes [ Time Frame: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline. ] P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
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Original Primary Outcome Measures ICMJE |
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes [ Time Frame: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6 ] P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
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Change History | Complete list of historical versions of study NCT02709096 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes | |||
Official Title ICMJE | BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes | |||
Brief Summary | This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate the comparative reduction of Propionibacterium acnes in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control. | |||
Detailed Description | The objective of this study is to evaluate the comparative reduction of Propionibacterium acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel or BPX-01 Vehicle control Gel. A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline are also of significant interest to the sponsor. This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as a topical gel once daily for four (4) weeks. This is a six (6) week study with a four (4) week treatment period and a two (2) week post treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and basic hematology and chemistry laboratory values will be collected. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Acne Vulgaris | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
33 | |||
Original Estimated Enrollment ICMJE |
30 | |||
Actual Study Completion Date ICMJE | June 2016 | |||
Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 40 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02709096 | |||
Other Study ID Numbers ICMJE | BPX-01-C02 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | BioPharmX, Inc. | |||
Study Sponsor ICMJE | BioPharmX, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | BioPharmX, Inc. | |||
Verification Date | August 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |