NCT03667222

Topical Minocycline Gel for Inflammatory Lesions of Papulopustular Rosacea

PRISM: A Double Blind, Randomized, Vehicle Controlled Phase 2 Study to Assess the Safety and Efficacy of BPX-04 Minocycline Topical Gel in the Treatment of Inflammatory Lesions of Papulopustular Rosacea

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: BioPharmX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Subjects will apply approximately 1 gram of topical gel once each day for a 12 week duration. They will come to the study site at Screening, Baseline, and Weeks 4, 8, and 12 or early termination (ET) for the protocol required efficacy and safety evaluations. At each visit, efficacy will be assessed by rosacea lesion counts, IGA, PGI-S, PGI-I, CGI-S, CGI-I, RosaQoL, Erythema Assessment Scale, Telangiectasia Assessment Scale and subject satisfaction questionnaire. Safety will be assessed with vital signs, physical examination, laboratory tests such as clinical hematology and chemistries, investigators' and subjects' assessments of cutaneous tolerability, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, and incidence of TEAEs. Blood samples will be collected to evaluate the level of minocycline in plasma at Baseline and Week 12/ET.

Conditions

• Papulopustular Rosacea

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-18
• Primary completion: 2019-05-17
• Completion: 2019-08-17
• First posted: 2018-09-12
• Last updated: 2019-07-10

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study