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

Phase 2

Completed

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

• Registration Number: NCT00617903
• Lead Sponsor: LEO Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2013-05-02
• Results First Submitted QC: 2013-05-02
• Results First Posted: 2013-07-04
• Status Verified: 2013-12
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Azelaic acid foam, 15% (BAY39-6251)	Azelaic acid	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
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)	At End of Study (Week 12)	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).
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)	Baseline and End of Study (Week 12)	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe

Secondary Outcome Measures

Name	Time	Method
Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12	Baseline and Weeks 4, 8 and 12
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)	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).
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)	Baseline and 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).
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)
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)
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12	Baseline and Weeks 4, 8 and 12	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)	At Weeks 4, 8, 12 and End of Study (LOCF)	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)	Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Investigator's Rating of Overall Improvement at End of Study	At End of Study (Week 12)	Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration
Patients' Rating of Overall Improvement at End of Study	At End of Study (Week 12)	Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse
Patients' Opinion on Cosmetic Acceptability at End of Study	At End of Study (Week 12)	Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)	At Weeks 4, 8, 12 and End of Study (LOCF)	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)	Baseline and Weeks 4, 8, 12 and End of Study (LOCF)	Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12	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).").
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)	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).