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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01025635
First received: November 26, 2009
Last updated: April 18, 2014
Last verified: April 2014
  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.


Condition Intervention Phase
Papulopustular Rosacea
Drug: Azelaic acid foam 15%
Drug: Vehicle foam
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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'.


Enrollment: 401
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025635

Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
Birmingham, Alabama, United States, 35209
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01025635     History of Changes
Other Study ID Numbers: 14955, 1403120
Study First Received: November 26, 2009
Results First Received: May 7, 2013
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
rosacea
papulopustular
azelaic acid
foam

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on September 14, 2014