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

Completed · Phase 2

Conditions studied: Papulopustular Rosacea

In brief

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.

Key facts

Study ID

NCT01025635

Run by

LEO Pharma

People needed

401

Starts

2009-12-01

Expected to finish

2010-08-01

Last updated by the study team

2020-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Birmingham, Alabama, United States
• Study site — Fremont, California, United States
• Study site — Santa Monica, California, United States
• Study site — Miami, Florida, United States
• Study site — Miramar, Florida, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — High Point, North Carolina, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Johnston, Rhode Island, United States
• Study site — Simpsonville, South Carolina, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Plano, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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