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

NCT01555463 | Completed Phase 3 Results

• 2 other identifiers: 160801401846
• Study Type: interventional
• Target: 961
• Locations: 1 country
• Sites: 49

Brief Summary

The purpose of this study is to assess the safety and efficacy of azelaic acid (AzA) foam, 15% topically applied twice daily for 12 weeks in subjects with papulopustular rosacea compared to its vehicle.

Conditions

Papulopustular Rosacea

Keywords

Rosacea

Outcome Measures

Primary Outcomes (2)

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

  Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous 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 (LOCF), up to 12 weeks

• Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)

  The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.

  Baseline and end of treatment (LOCF), up to 12 weeks

Secondary Outcomes (16)

• Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)

  Baseline and end of treatment (LOCF), up to 12 weeks

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

  At end of treatment (LOCF), up to 12 weeks

• Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)

  Baseline and end of treatment (LOCF), up to 12 weeks

• Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)

  At end of treatment (LOCF), up to 12 weeks

• Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)

  At end of treatment (LOCF), up to 12 weeks

Study Arms (2)

Azelaic acid foam, 15% (BAY39-6251)

EXPERIMENTAL

0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.

Drug: Azelaic acid foam, 15% (BAY39-6251)

Vehicle foam

PLACEBO COMPARATOR

0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.

Drug: Vehicle foam

Interventions

Azelaic acid foam, 15% (BAY39-6251) DRUG

Azelaic acid twice daily topical application

Azelaic acid foam, 15% (BAY39-6251)

Vehicle foam DRUG

twice daily topical application

Vehicle foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of papulopustular rosacea
• Free of any clinically significant disease, which could interfere with the study
• Male or female subject aged ≥ 18 years
• Willingness of subject to follow all study procedures
• Signed written informed consent before any study-related activities are carried out

You may not qualify if:

• Subjects who are known to be non-responders to azelaic acid
• Presence of dermatoses that might interfere with rosacea diagnosis
• Ocular rosacea; phymatous rosacea; subjects with plaque-type rosacea lesions, papulopustular rosacea that requires systemic treatment
• Topical use of any prescription or non-prescription medication to treat rosacea within 6 weeks prior to randomization and throughout the study
• Systemic use of any prescription or non-prescription medication to treat rosacea (Retinoids within 6 months, Tetracycline within 2 months, Corticosteroids, erythromycin, azithromycin, and/or metronidazole within 4 weeks) prior to randomization and throughout the study
• Facial laser surgery for telangiectasia (or other conditions) within 6 weeks prior to randomization
• Known hypersensitivity to any ingredients of the investigational product formulation
• Participation in another clinical research in parallel or within the last 4 weeks before randomization in this study
• Any condition or therapy that in the investigator's opinion may pose a risk to the subject or that could interfere with any evaluation in the study

Sponsors & Collaborators

• LEO Pharma: lead
• Bayer: collaborator

Study Sites (49)

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Birmingham, Alabama, 35209, United States

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Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35243, United States

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Fremont, California, 94538, United States

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Los Angeles, California, 90045, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92103, United States

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San Francisco, California, 94143-0660, United States

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Santa Ana, California, 92705, United States

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Santa Monica, California, 90404, United States

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Colorado Springs, Colorado, 80915, United States

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Boynton Beach, Florida, 33437, United States

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Boynton Beach, Florida, 33472-2952, United States

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Jacksonville, Florida, 32258, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33175, United States

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Miramar, Florida, 33027, United States

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Ormond Beach, Florida, 32174, United States

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Saint Augustine, Florida, 32086, United States

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Buffalo Grove, Illinois, 60089, United States

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Chicago, Illinois, 60625, United States

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Plainfield, Indiana, 46168, United States

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Louisville, Kentucky, 40202, United States

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Richmond, Kentucky, 40475, United States

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New Orleans, Louisiana, 70124, United States

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Warren, Michigan, 48088, United States

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West Bloomfield, Michigan, 48322, United States

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Fridley, Minnesota, 55432, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68144, United States

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Las Vegas, Nevada, 89128, United States

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Las Vegas, Nevada, 89144, United States

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East Windsor, New Jersey, 08520, United States

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New York, New York, 10029, United States

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Stony Brook, New York, 11790, United States

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Chapel Hill, North Carolina, 27517, United States

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Hickory, North Carolina, 28602, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27612, United States

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Winston-Salem, North Carolina, 27103, United States

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Johnston, Rhode Island, 02919, United States

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Anderson, South Carolina, 29621, United States

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Knoxville, Tennessee, 37922, United States

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Austin, Texas, 78759, United States

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Plano, Texas, 75093, United States

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Webster, Texas, 77598, United States

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Salt Lake City, Utah, 84117, United States

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Seattle, Washington, 98101, United States

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Spokane, Washington, 99204, United States

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Related Publications (1)

• Draelos ZD, Elewski BE, Harper JC, Sand M, Staedtler G, Nkulikiyinka R, Shakery K. A phase 3 randomized, double-blind, vehicle-controlled trial of azelaic acid foam 15% in the treatment of papulopustular rosacea. Cutis. 2015 Jul;96(1):54-61.

  PMID: 26244354 RESULT

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 9, 2023
• Results First Posted: January 27, 2015

Record last verified: 2015-12

Locations

US (49)