Evaluation of the Safety and Efficacy of Topical Roflumilast Cream in the Treatment of Facial Papulopustular Rosacea

Plain-language summary

This is a double blind single site vehicle controlled study. The following activities will be conducted at each visit. Baseline Research Center Visit Obtain a signed and dated, written ICF prior to any study-related procedures.· Obtain demographic data· Assign subject number based on the order in which subjects present to the research center· Obtain medical/surgical history· Obtain concomitant medications· Assess eligibility based on inclusion/exclusion criteria· Collect blood and urine samples for clinical laboratory tests and send to the central laboratory· Perform serum pregnancy test in all women of child bearing potential (WOCBP)· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for baseline visit· Randomize subject and dispense Investigational Study Medication and use instructions along with compliance diary· Schedule return visit Week 2 Phone Call· Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Assess compliance Weeks 4, 8 Research Center Visit Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Collect a urine sample from female subjects of childbearing potential for a urine pregnancy test· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary and Investigational Study Medication, collect used Investigational Study Medication and redispense as necessary· Schedule return visit Week 12 Research Center Visit· Reassess medical/surgical history· Reassess concomitant medications· Assess adverse events· Collect a urine sample from female subjects of childbearing potential for a urine pregnancy test· Collect blood and urine samples for clinical laboratory tests and send to the central laboratory· Obtain vitals· Assess IGA, inflammation, erythema· Perform facial lesion counts· Perform local signs and symptoms assessments· Perform Columbia Suicide Severity Rating Scale (C-SSRS) for return visits· Assess compliance diary and Investigational Study Medication· Collect diary and Investigational Study Medication· Release subject from study participation

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