Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Study to Investigate Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily in Subjects With Papulopustular Rosacea
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- LEO Pharma
- Enrollment
- 401
- Primary Endpoint
- Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
Study Overview
Brief Summary
This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Signed written informed consent
- •Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent erythema with or without telangiectasia
- •Free of any clinically significant disease which could interfere with the study
- •Willingness to follow all study procedures
- •Male or female patient at least 18 years of age
Exclusion Criteria
- •Subjects known to be non-responders to azelaic acid
- •Presence of dermatoses that might interfere with the rosacea diagnosis or the evaluation of treatment results
- •Ocular rosacea, phymatous rosacea
- •Any condition or therapy that in the opinion of the investigator may pose a risk to the patient of interfere with any evaluation in the study
- •Facial laser surgery in the 6 weeks prior to the study
- •Topical or systemic use of prescription or non-prescription medications to treat rosacea
- •Use of any agent other than the investigational drugs to treat rosacea during the study
- •Expected use or change in dose in the 90 days prior to the study of beta-blockers, vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions
- •Known hypersensitivity to any ingredients of the investigational product formulation
- •Alcohol or drug abuse
- •Incapability of giving fully informed consent
- •Subject is dependent person, i.e., a relative/family member of the investigator and/or is a member of the investigator's staff
- •Participation in another clinical research study within the last 4 weeks before randomization in this study
Arms & Interventions
Azelaic acid foam, 15% (BAY39-6251)
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Intervention: Azelaic acid foam 15% (Drug)
Vehicle foam
Participants received vehicle foam topically twice daily for 12 weeks
Intervention: Vehicle foam (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
Time Frame: At End of treatment (up to 12 weeks) (LOCF)
The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
Time Frame: Baseline and End of treatment (up to 12 weeks) (LOCF)
Secondary Outcomes
- Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)(At End of treatment (up to 12 weeks) (LOCF))
- Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)(At End of treatment (up to 12 weeks) (LOCF))