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

Part of paid clinical trials in High Point, North Carolina.

Sponsor
Dermatology Consulting Services, PLLC
Study ID
NCT05278624
Phase
PHASE2
Status
Completed

Conditions

  • Rosacea

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Apr 15, 2022
Status verified
May 2023
Primary completion
Feb 17, 2023
Completion
Feb 17, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active plus vehicle arm
    Subjects will be dispensed a tube containing roflumilast and vehicle in topical formulation
  • Placebo Comparator: Vehicle arm
    Subjects will be dispensed a tube containing vehicle only in a topical formulation

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: 12 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dermatology Consulting Services, PLLCHigh PointNorth Carolina27262-

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