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

• ClinicalTrials.gov Identifier: NCT01025635
• Recruitment Status: Completed
• First Posted: December 3, 2009
• Results First Posted: July 1, 2013
• Last Update Posted: March 31, 2020
• Sponsor: LEO Pharma
• Collaborator: Bayer
• Information provided by (Responsible Party): LEO Pharma

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Papulopustular Rosacea	Drug: Azelaic acid foam 15%; Drug: Vehicle foam	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 401 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: December 2009
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: August 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Azelaic acid foam, 15% (BAY39-6251); Participants received azelaic acid foam, 15% topically twice daily for 12 weeks	Drug: Azelaic acid foam 15%; Applied topically twice daily for 12 weeks
Placebo Comparator: Vehicle foam; Participants received vehicle foam topically twice daily for 12 weeks	Drug: Vehicle foam; Applied topically twice daily for 12 weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward) [ Time Frame: At End of treatment (up to 12 weeks) (LOCF) ]
   The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.
2. Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) [ Time Frame: Baseline and End of treatment (up to 12 weeks) (LOCF) ]

Secondary Outcome Measures :

1. Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF) [ Time Frame: At End of treatment (up to 12 weeks) (LOCF) ]
2. Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF) [ Time Frame: At End of treatment (up to 12 weeks) (LOCF) ]
   The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Subjects with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35209

Birmingham, Alabama, United States, 35233

United States, California

Fremont, California, United States, 94538

Santa Monica, California, United States, 90404

United States, Florida

Miami, Florida, United States, 33175

Miramar, Florida, United States, 33027

United States, Nebraska

Omaha, Nebraska, United States, 68144

United States, New Mexico

Albuquerque, New Mexico, United States, 87106

United States, North Carolina

High Point, North Carolina, United States, 27262

Wilmington, North Carolina, United States, 28401

Winston-Salem, North Carolina, United States, 27103

United States, Oregon

Portland, Oregon, United States, 97210

United States, Rhode Island

Johnston, Rhode Island, United States, 02919

United States, South Carolina

Simpsonville, South Carolina, United States, 29681

United States, Tennessee

Knoxville, Tennessee, United States, 37922

Nashville, Tennessee, United States, 37215

United States, Texas

Austin, Texas, United States, 78759

Plano, Texas, United States, 75093

United States, Utah

Salt Lake City, Utah, United States, 84124

United States, Wisconsin

Madison, Wisconsin, United States, 53719

Sponsors and Collaborators

LEO Pharma

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

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.

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT01025635
• Other Study ID Numbers: 14955; 1403120 ( Other Identifier: Company internal )
• First Posted: December 3, 2009
• Results First Posted: July 1, 2013
• Last Update Posted: March 31, 2020
• Last Verified: April 2014

Keywords provided by LEO Pharma:

rosacea; papulopustular; azelaic acid; foam

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Azelaic acid; Antineoplastic Agents; Dermatologic Agents