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

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.

Official Title
-----------------
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

Conditions
-----------------
Papulopustular Rosacea

Intervention / Treatment
-----------------
* Drug: Azelaic acid foam 15%
* Drug: Vehicle foam


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Azelaic acid foam, 15% (BAY39-6251)<br>Participants received azelaic acid foam, 15% topically twice daily for 12 weeks | Drug: Azelaic acid foam 15%<br>* Applied topically twice daily for 12 weeks<br>|
| Placebo Comparator: Vehicle foam<br>Participants received vehicle foam topically twice daily for 12 weeks | Drug: Vehicle foam<br>* Applied topically twice daily for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) | 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. | At End of treatment (up to 12 weeks) (LOCF) | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (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'. | At End of treatment (up to 12 weeks) (LOCF) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rosacea, papulopustular, azelaic acid, foam