Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea
NCT03667222 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207
Last updated 2019-07-10
Summary
This is a 12-week, multicenter, double-blind, randomized, two-arm, vehicle controlled study. Subjects will be randomized 1:1 to BPX-04 minocycline topical gel 1% or vehicle. This study will include approximately 176 randomized subjects with inflammatory lesions of papulopustular rosacea on the face, defined by an IGA score of 3 (moderate) or 4 (severe) at Baseline. Subjects will be healthy male or female subjects aged 18 years or older. There will be up to 20 study sites in the USA.
Conditions
- Papulopustular Rosacea
Interventions
- DRUG
-
minocycline topical gel
Once daily administration of BPX-04 minocycline gel for 12 weeks
- DRUG
-
topical gel vehicle
Once daily administration of BPX-04 gel vehicle for 12 weeks
Sponsors & Collaborators
-
BioPharmX, Inc.
lead INDUSTRY
Principal Investigators
-
AnnaMarie Daniels · BioPharmX, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-18
- Primary Completion
- 2019-05-17
- Completion
- 2019-08-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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