Phase 2
Completed N=18
Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel
Source: ClinicalTrials.gov NCT02946788 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Change From Baseline in Inflammatory Lesion Counts at Week 12 — 22.3; 19.0 inflammatory lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Inflammatory Lesion Counts at Week 12 |
22.3; 19.0 | — |
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. Informational only — not medical advice.