Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
NCT ID: NCT01025635
Last Updated: 2020-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
401 participants
INTERVENTIONAL
2009-12-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Azelaic acid foam, 15% (BAY39-6251)
Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
Azelaic acid foam 15%
Applied topically twice daily for 12 weeks
Vehicle foam
Participants received vehicle foam topically twice daily for 12 weeks
Vehicle foam
Applied topically twice daily for 12 weeks
Interventions
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Azelaic acid foam 15%
Applied topically twice daily for 12 weeks
Vehicle foam
Applied topically twice daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Fremont, California, United States
Santa Monica, California, United States
Miami, Florida, United States
Miramar, Florida, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
High Point, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Portland, Oregon, United States
Johnston, Rhode Island, United States
Simpsonville, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Plano, Texas, United States
Salt Lake City, Utah, United States
Madison, Wisconsin, United States
Countries
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References
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Draelos ZD, Elewski B, Staedtler G, Havlickova B. Azelaic acid foam 15% in the treatment of papulopustular rosacea: a randomized, double-blind, vehicle-controlled study. Cutis. 2013 Dec;92(6):306-17.
Other Identifiers
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1403120
Identifier Type: OTHER
Identifier Source: secondary_id
14955
Identifier Type: -
Identifier Source: org_study_id
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