Phase 2
N=18
Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT02946788 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Change From Baseline in Inflammatory Lesion Counts at Week 12 — 22.3; 19.0 inflammatory lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Minocycline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioPharmX, Inc.
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Inflammatory Lesion Counts at Week 12 |
22.3; 19.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02946788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.