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

NCT01025635 | Completed Phase 2 Results

• 2 other identifiers: 149551403120
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 20

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.

Conditions

Papulopustular Rosacea

Keywords

rosacea; papulopustular; azelaic acid; foam

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)

  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 Outcomes (2)

• 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)

  At End of treatment (up to 12 weeks) (LOCF)

Study Arms (2)

Azelaic acid foam, 15% (BAY39-6251)

EXPERIMENTAL

Participants received azelaic acid foam, 15% topically twice daily for 12 weeks

Drug: Azelaic acid foam 15%

Vehicle foam

PLACEBO COMPARATOR

Participants received vehicle foam topically twice daily for 12 weeks

Drug: Vehicle foam

Interventions

Azelaic acid foam 15% DRUG

Applied topically twice daily for 12 weeks

Azelaic acid foam, 15% (BAY39-6251)

Vehicle foam DRUG

Applied topically twice daily for 12 weeks

Vehicle foam

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead
• Bayer: collaborator

Study Sites (20)

Unknown Facility

Birmingham, Alabama, 35209, United States

Location

Unknown Facility

Birmingham, Alabama, 35233, United States

Location

Unknown Facility

Fremont, California, 94538, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Miami, Florida, 33175, United States

Location

Unknown Facility

Miramar, Florida, 33027, United States

Location

Unknown Facility

Omaha, Nebraska, 68144, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

High Point, North Carolina, 27262, United States

Location

Unknown Facility

Wilmington, North Carolina, 28401, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Portland, Oregon, 97210, United States

Location

Unknown Facility

Johnston, Rhode Island, 02919, United States

Location

Unknown Facility

Simpsonville, South Carolina, 29681, United States

Location

Unknown Facility

Knoxville, Tennessee, 37922, United States

Location

Unknown Facility

Nashville, Tennessee, 37215, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

Plano, Texas, 75093, United States

Location

Unknown Facility

Salt Lake City, Utah, 84124, United States

Location

Unknown Facility

Madison, Wisconsin, 53719, United States

Location

Related Publications (1)

• 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.

  PMID: 24416747 BACKGROUND

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer HealthCare Pharmaceuticals, Inc. (formerly Intendis GmbH)

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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 3, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 31, 2020
• Results First Posted: July 1, 2013

Record last verified: 2014-04

Locations

US (20)