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

Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Papulopustular Rosacea

Intervention: Azelaic acid foam 15% (Drug); Vehicle foam (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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.

Clinical Details

Official title: Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Study to Investigate Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily in Subjects With Papulopustular Rosacea

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)

Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)

Secondary outcome:

Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)

Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Birmingham, Alabama 35209, United States

Birmingham, Alabama 35233, United States

Fremont, California 94538, United States

Santa Monica, California 90404, United States

Miami, Florida 33175, United States

Miramar, Florida 33027, United States

Omaha, Nebraska 68144, United States

Albuquerque, New Mexico 87106, United States

High Point, North Carolina 27262, United States

Wilmington, North Carolina 28401, United States

Winston Salem, North Carolina 27103, United States

Portland, Oregon 97210, United States

Johnston, Rhode Island 02919, United States

Simpsonville, South Carolina 29681, United States

Knoxville, Tennessee 37922, United States

Nashville, Tennessee 37215, United States

Austin, Texas 78759, United States

Plano, Texas 75093, United States

Salt Lake City, Utah 84124, United States

Madison, Wisconsin 53719, United States

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Related publications:

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.

Starting date: December 2009
Last updated: April 18, 2014

Page last updated: August 20, 2015

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