Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
NCT ID: NCT01555463
Last Updated: 2023-06-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
961 participants
INTERVENTIONAL
2012-09-30
2014-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
NCT01025635
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea
NCT00617903
Safety and Pharmacokinetics of Azelaic Acid Foam, 15% in Papulopustular Rosacea
NCT01257919
Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea
NCT03418610
A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily
NCT00417937
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Evaluation of all adverse events will be covered in Adverse Events section.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Azelaic acid foam, 15% (BAY39-6251)
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
Azelaic acid foam, 15% (BAY39-6251)
Azelaic acid twice daily topical application
Vehicle foam
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
Vehicle foam
twice daily topical application
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Azelaic acid foam, 15% (BAY39-6251)
Azelaic acid twice daily topical application
Vehicle foam
twice daily topical application
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Free of any clinically significant disease, which could interfere with the study
* Male or female subject aged ≥ 18 years
* Willingness of subject to follow all study procedures
* Signed written informed consent before any study-related activities are carried out
Exclusion Criteria
* Presence of dermatoses that might interfere with rosacea diagnosis
* Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
* Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
* Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
* Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
* Known hypersensitivity to any ingredients of the investigational product formulation
* Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
* Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
LEO Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Fremont, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Santa Monica, California, United States
Colorado Springs, Colorado, United States
Boynton Beach, Florida, United States
Boynton Beach, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miramar, Florida, United States
Ormond Beach, Florida, United States
Saint Augustine, Florida, United States
Buffalo Grove, Illinois, United States
Chicago, Illinois, United States
Plainfield, Indiana, United States
Louisville, Kentucky, United States
Richmond, Kentucky, United States
New Orleans, Louisiana, United States
Warren, Michigan, United States
West Bloomfield, Michigan, United States
Fridley, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
East Windsor, New Jersey, United States
New York, New York, United States
Stony Brook, New York, United States
Chapel Hill, North Carolina, United States
Hickory, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Johnston, Rhode Island, United States
Anderson, South Carolina, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Plano, Texas, United States
Webster, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Draelos ZD, Elewski BE, Harper JC, Sand M, Staedtler G, Nkulikiyinka R, Shakery K. A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. Cutis. 2015 Jul;96(1):54-61.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1401846
Identifier Type: OTHER
Identifier Source: secondary_id
16080
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.