Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
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)
1 other identifier
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2017
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2016
CompletedFirst Posted
Study publicly available on registry
October 27, 2016
CompletedStudy Start
First participant enrolled
March 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedResults Posted
Study results publicly available
July 26, 2022
CompletedJuly 26, 2022
July 1, 2022
1.2 years
October 25, 2016
July 3, 2022
July 3, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
BPX-01 1%
EXPERIMENTALBPX-01 1% minocycline topical gel
BPX-01 2%
EXPERIMENTALBPX-01 2% minocycline topical gel
Interventions
BPX-01 1 or 2% topical gel will be applied to face once daily
Eligibility Criteria
You may qualify if:
- \- moderate to severe inflammatory non-nodular acne vulgaris
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioPharmX, Inc.lead
Study Sites (2)
Study Center
Coral Gables, Florida, 33146, United States
Study Center
Las Vegas, Nevada, 89128, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
not powered for statistical significance. Small, unblinded study
Results Point of Contact
- Title
- Alan Mendelsohn, MD
- Organization
- Timber Pharmaceuticals
Study Officials
- STUDY DIRECTOR
AnnaMarie Daniels
BioPharmX, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2016
First Posted
October 27, 2016
Study Start
March 13, 2017
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
July 26, 2022
Results First Posted
July 26, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share