Back to resultsExploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
Primary Purpose
Papulopustular Rosacea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azelaic acid
Vehicle foam
Sponsored by
About this trial
This is an interventional treatment trial for Papulopustular Rosacea focused on measuring rosacea, papulopustular, azelaic acid, foam
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Azelaic acid foam, 15% (BAY39-6251)
Vehicle foam
Arm Description
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Participants received vehicle foam topically twice daily for 12 weeks
Outcomes
Primary Outcome Measures
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)
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).
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
Secondary Outcome Measures
Mean of Inflammatory Lesion Count Per Participant 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
Percent Change From Baseline in Inflammatory Lesion Count Per Participant at 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).
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).
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
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
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
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
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
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
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
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
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
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).").
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).
Full Information
NCT ID
NCT00617903
First Posted
January 22, 2008
Last Updated
March 30, 2020
Sponsor
LEO Pharma
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00617903
Brief Title
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
rosacea, papulopustular, azelaic acid, foam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azelaic acid foam, 15% (BAY39-6251)
Arm Type
Experimental
Arm Description
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Arm Title
Vehicle foam
Arm Type
Placebo Comparator
Arm Description
Participants received vehicle foam topically twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Azelaic acid
Intervention Description
15% foam to be applied topically twice daily
Intervention Type
Drug
Intervention Name(s)
Vehicle foam
Intervention Description
Active-ingredient-free vehicle to be applied topically twice daily
Primary Outcome Measure Information:
Title
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)
Time Frame
Baseline and End of Study (Week 12)
Title
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)
Description
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).
Time Frame
At End of Study (Week 12)
Title
Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
Description
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame
Baseline and End of Study (Week 12)
Secondary Outcome Measure Information:
Title
Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame
At Weeks 4, 8, 12 and End of Study (LOCF)
Title
Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
Time Frame
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Title
Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description
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).
Time Frame
At Weeks 4, 8, 12 and End of Study (LOCF)
Title
Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description
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).
Time Frame
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Title
Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame
At Weeks 4, 8, 12 and End of Study (LOCF)
Title
Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Title
Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
Description
Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame
Baseline and Weeks 4, 8 and 12
Title
Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame
At Weeks 4, 8, 12 and End of Study (LOCF)
Title
Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Title
Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
Description
Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe
Time Frame
Baseline and Weeks 4, 8, 12 and End of Study (LOCF)
Title
Investigator's Rating of Overall Improvement at End of Study
Description
Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration
Time Frame
At End of Study (Week 12)
Title
Patients' Rating of Overall Improvement at End of Study
Description
Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse
Time Frame
At End of Study (Week 12)
Title
Patients' Opinion on Cosmetic Acceptability at End of Study
Description
Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion
Time Frame
At End of Study (Week 12)
Title
Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
Description
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).").
Time Frame
At Weeks 4, 8 and 12
Title
Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
Description
IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2).
Time Frame
At Weeks 4, 8, 12 and End of Study (LOCF)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66062
Country
United States
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
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