Trial Condition(s):

Papulopustular Rosacea

Safety and efficacy of Azelaic Acid Foam, 15% in papulopustular rosacea

Bayer Identifier:

14955

ClinicalTrials.gov Identifier:

NCT01025635

EudraCT Number:

Not Available

Study Completed

Trial Purpose

This study will investigate the safety and efficacy of a new formulation of an existing medication for the treatment of papulopustular rosacea. The study will test the active ingredient plus foam against foam alone.

Inclusion Criteria
- Signed written informed consent
 - 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
- Subjects known to be non-responders to azelaic acid
 - 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

Trial Summary

Enrollment Goal
401
Trial Dates
black-arrow
Phase
2
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

Research Across America

Plano, United States, 75093

Status
Completed
 
Locations

Center for Dermatology Clinical Research

Fremont, United States, 94538

Status
Completed
 
Locations

New Hanover Medical Research

Wilmington, United States, 28401

Status
Completed
 
Locations

Dermatology Consulting Services

High Point, United States, 27262

Status
Completed
 
Locations

University of Alabama- Birmingham

Birmingham, United States, 35233

Status
Completed
 
Locations

FXM Research Miramar

Miramar, United States, 33027

Status
Completed
 
Locations

Clinical Partners, LLC

Johnston, United States, 02919

Status
Completed
 
Locations

Tennessee Clinical Research

Nashville, United States, 37215

Status
Completed
 
Locations

The Skin Wellness Center

Knoxville, United States, 37922

Status
Completed
 
Locations

Radiant Research

Birmingham, United States, 35209

Status
Completed
 
Locations

Derm Research

Austin, United States, 78759

Status
Completed
 
Locations

Piedmont Research Association Inc.

Winston Salem, United States, 27103

Status
Completed
 
Locations

Oregon Dermatology & Research Center

Portland, United States, 97210

Status
Completed
 
Locations

Investigative Site

Omaha, United States, 68144

Status
Completed
 
Locations

Madison Skin & Research Center

Madison, United States, 53719

Status
Completed
 
Locations

Dermatology Research Center

Salt Lake City, United States, 84124

Status
Completed
 
Locations

Academic Dermatology Associates

Albuquerque, United States, 87106

Status
Completed
 
Locations

Palmetto Clinical Trial Services, LLC

Simpsonville, United States, 29681

Status
Completed
 
Locations

FXM Research Corporation

Miami, United States, 33175

Status
Completed
 
Locations

Clinical Science Institute

Santa Monica, United States, 90404

Status
Completed
 

Trial Design