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

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

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.

Study Overview

• Status: Completed
• Conditions: Papulopustular Rosacea
• Intervention / Treatment: Drug: Azelaic acid foam 15%; Drug: Vehicle foam

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
    • Birmingham, Alabama, United States, 35233
  • California
    • Fremont, California, United States, 94538
    • Santa Monica, California, United States, 90404
  • Florida
    • Miami, Florida, United States, 33175
    • Miramar, Florida, United States, 33027
  • Nebraska
    • Omaha, Nebraska, United States, 68144
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • North Carolina
    • High Point, North Carolina, United States, 27262
    • Wilmington, North Carolina, United States, 28401
    • Winston-Salem, North Carolina, United States, 27103
  • Oregon
    • Portland, Oregon, United States, 97210
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
  • South Carolina
    • Simpsonville, South Carolina, United States, 29681
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
    • Nashville, Tennessee, United States, 37215
  • Texas
    • Austin, Texas, United States, 78759
    • Plano, Texas, United States, 75093
  • Utah
    • Salt Lake City, Utah, United States, 84124
  • Wisconsin
    • Madison, Wisconsin, United States, 53719

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)	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.	At End of treatment (up to 12 weeks) (LOCF)
Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)		Baseline and End of treatment (up to 12 weeks) (LOCF)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)		At End of treatment (up to 12 weeks) (LOCF)
Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (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'.	At End of treatment (up to 12 weeks) (LOCF)

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Bayer

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: November 26, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Actual): March 31, 2020
• Last Update Submitted That Met QC Criteria: March 30, 2020
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: rosacea; azelaic acid; foam; papulopustular
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: 14955; 1403120 (Other Identifier: Company internal)