Papulopustular Rosacea Clinical Trial
Official title:
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
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.
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.
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