Trial Condition(s):

Papulopustular Rosacea

Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea

Bayer Identifier:

16080

ClinicalTrials.gov Identifier:

NCT01555463

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

Inclusion Criteria
- Diagnosis of papulopustular rosacea
 - 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
- Subjects who are known to be non-responders to azelaic acid
 - 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

Trial Summary

Enrollment Goal
961
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Austin, United States, 78759

Status
Completed
 
Locations

Investigative Site

Plano, United States, 75093

Status
Completed
 
Locations

Investigative Site

Santa Ana, United States, 92705

Status
Completed
 
Locations

Investigative Site

Spokane, United States, 99204

Status
Completed
 
Locations

Investigative Site

Miami, United States, 33144

Status
Completed
 
Locations

Investigative Site

Boynton Beach, United States, 33437

Status
Completed
 
Locations

Investigative Site

Stony Brook, United States, 11790

Status
Completed
 
Locations

Investigative Site

Fremont, United States, 94538

Status
Completed
 
Locations

Investigative Site

High Point, United States, 27262

Status
Completed
 
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Investigative Site

Hickory, United States, 28602

Status
Completed
 
Locations

Investigative Site

Birmingham, United States, 35233

Status
Completed
 
Locations

Investigative Site

Miramar, United States, 33027

Status
Completed
 
Locations

Investigative Site

Johnston, United States, 02919

Status
Completed
 
Locations

Investigative Site

San Diego, United States, 92103

Status
Completed
 
Locations

Investigative Site

Buffalo Grove, United States, 60089

Status
Completed
 
Locations

Investigative Site

Knoxville, United States, 37922

Status
Completed
 
Locations

Investigative Site

Warren, United States, 48088

Status
Completed
 
Locations

Investigative Site

Birmingham, United States, 35243

Status
Completed
 
Locations

Investigative Site

Seattle, United States, 98101

Status
Completed
 
Locations

Investigative Site

Fridley, United States, 55432

Status
Completed
 
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Investigative Site

Winston-Salem, United States, 27103

Status
Completed
 
Locations

Investigative Site

St. Louis, United States, 63141

Status
Completed
 
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Investigative Site

Raleigh, United States, 27612

Status
Completed
 
Locations

Investigative Site

Birmingham, United States, 35209

Status
Completed
 
Locations

Investigative Site

Chapel Hill, United States, 27517

Status
Completed
 
Locations

Investigative Site

New York, United States, 10029

Status
Completed
 
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Investigative Site

Jacksonville, United States, 32258

Status
Completed
 
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Investigative Site

Omaha, United States, 68144

Status
Completed
 
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Investigative Site

Anderson, United States, 29621

Status
Completed
 
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Investigative Site

Los Angeles, United States, 90045

Status
Completed
 
Locations

Investigative Site

Ormond Beach, United States, 32174

Status
Completed
 
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Investigative Site

Las Vegas, United States, 89128

Status
Completed
 
Locations

Investigative Site

San Francisco, United States, 94143-0660

Status
Completed
 
Locations

Investigative Site

Las Vegas, United States, 89144

Status
Completed
 
Locations

Investigative Site

Salt Lake City, United States, 84117

Status
Completed
 
Locations

Investigative Site

Miami, United States, 33175

Status
Completed
 
Locations

Investigative Site

Santa Monica, United States, 90404

Status
Completed
 
Locations

Investigative Site

Louisville, United States, 40202

Status
Completed
 
Locations

Investigative Site

Plainfield, United States, 46168

Status
Completed
 
Locations

Investigative Site

Webster, United States, 77598

Status
Completed
 
Locations

Investigative Site

Colorado Springs, United States, 80915

Status
Completed
 
Locations

Investigative Site

West Bloomfield, United States, 48322

Status
Completed
 
Locations

Investigative Site

St. Augustine, United States, 32086

Status
Completed
 
Locations

Investigative Site

Boynton Beach, United States, 33472-2952

Status
Completed
 
Locations

Investigative Site

Chicago, United States, 60625

Status
Completed
 
Locations

Investigative Site

Richmond, United States, 40475

Status
Completed
 
Locations

Investigative Site

New Orleans, United States, 70124

Status
Completed
 
Locations

Investigative Site

East Windsor, United States, 08520

Status
Completed
 
Locations

Investigative Site

Sacramento, United States, 95816

Status
Terminated
 

Trial Design