Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

Study Overview
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Brief Summary
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This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.

Official Title
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A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea

Conditions
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Papulopustular Rosacea

Intervention / Treatment
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* Drug: Azelaic acid
* Drug: Vehicle foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male and female patient at least 18 years of age signed informed consent Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia Ability and willingness to accept and comply with treatment and required medical examinations Exclusion Criteria: Known non-responders to azelaic acid Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea Presence of dermatoses that could interfere with the rosacea diagnosis Treatment with isotretinoin in the six months prior to randomization Treatment of the face with topical retinoids during the two weeks prior to randomization Treatment with oral antibiotics during the four weeks prior to randomization Treatment with topical antibiotics Treatment with systemic corticosteroids during 4 weeks prior to randomization Treatment of the face with topical corticosteroids during 2 weeks prior to randomization Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization Use of a sauna during 2 weeks prior to randomization and during the study Facial laser surgery for telangiectasia during 6 weeks prior to randomization Planned concurrent use of any treatment other than study medication that affects rosacea History of hypersensitivity to propylene glycol or any other ingredient of the study drugs Participation in another clinical trial during the last 4 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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<br>* 15% foam to be applied topically twice daily<br>|
| Placebo Comparator: Vehicle foam<br>Participants received vehicle foam topically twice daily for 12 weeks | Drug: Vehicle foam<br>* Active-ingredient-free vehicle to be applied topically twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward) |  | Baseline and End of Study (Week 12) | 
| Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). | At End of Study (Week 12) | 
| Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe | Baseline and End of Study (Week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) |  | At Weeks 4, 8, 12 and End of Study (LOCF) | 
| Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12 |  | Baseline and Weeks 4, 8 and 12 | 
| Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF) |  | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | 
| Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). | At Weeks 4, 8, 12 and End of Study (LOCF) | 
| Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF) | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | 
| Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe | At Weeks 4, 8, 12 and End of Study (LOCF) | 
| Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | 
| Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12 | Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe | Baseline and Weeks 4, 8 and 12 | 
| Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe | At Weeks 4, 8, 12 and End of Study (LOCF) | 
| Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | 
| Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF) | Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe | Baseline and Weeks 4, 8, 12 and End of Study (LOCF) | 
| Investigator's Rating of Overall Improvement at End of Study | Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration | At End of Study (Week 12) | 
| Patients' Rating of Overall Improvement at End of Study | Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse | At End of Study (Week 12) | 
| Patients' Opinion on Cosmetic Acceptability at End of Study | Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion | At End of Study (Week 12) | 
| Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12 | IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).). | At Weeks 4, 8 and 12 | 
| Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF) | IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2). | At Weeks 4, 8, 12 and End of Study (LOCF) | 

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