Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea

Phase 2

Completed

• Conditions: Papulopustular Rosacea
• Interventions: Drug: Azelaic acid foam 15%; Drug: Vehicle foam

• Registration Number: NCT01025635
• Lead Sponsor: LEO Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-26
• Study Start: 2009-12
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2013-05-07
• Results First Submitted QC: 2013-05-07
• Results First Posted: 2013-07-01
• Status Verified: 2014-04
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azelaic acid foam, 15% (BAY39-6251)	Azelaic acid foam 15%	Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Vehicle foam	Vehicle foam	Participants received vehicle foam topically twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)	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)	Baseline and End of treatment (up to 12 weeks) (LOCF)

Secondary Outcome Measures

Name	Time	Method
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)	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. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Subjects with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'.
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)