check_circleStudy Completed

Papulopustular Rosacea

Bayer Identifier:

14955

ClinicalTrials.gov Identifier:

NCT01025635

EudraCT Number:

Not Available

EU CT Number:

Not Available
Safety and efficacy of Azelaic Acid Foam, 15% in papulopustular rosacea

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
401
Trial Dates
December 2009 - August 2010
Phase
Phase 2
Could I Receive a placebo
No
Products
Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Research Across AmericaPlano, 75093, United States
Completed
Center for Dermatology Clinical ResearchFremont, 94538, United States
Completed
New Hanover Medical ResearchWilmington, 28401, United States
Completed
Dermatology Consulting ServicesHigh Point, 27262, United States
Completed
University of Alabama- BirminghamBirmingham, 35233, United States
Completed
FXM Research MiramarMiramar, 33027, United States
Completed
Clinical Partners, LLCJohnston, 02919, United States
Completed
Tennessee Clinical ResearchNashville, 37215, United States
Completed
The Skin Wellness CenterKnoxville, 37922, United States
Completed
Radiant ResearchBirmingham, 35209, United States
Completed
Derm ResearchAustin, 78759, United States
Completed
Piedmont Research Association Inc.Winston Salem, 27103, United States
Completed
Oregon Dermatology & Research CenterPortland, 97210, United States
Completed
Omaha, 68144, United States
Completed
Madison Skin & Research CenterMadison, 53719, United States
Completed
Dermatology Research CenterSalt Lake City, 84124, United States
Completed
Academic Dermatology AssociatesAlbuquerque, 87106, United States
Completed
Palmetto Clinical Trial Services, LLCSimpsonville, 29681, United States
Completed
FXM Research CorporationMiami, 33175, United States
Completed
Clinical Science InstituteSanta Monica, 90404, United States

Primary Outcome

  • 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.
    date_rangeTime Frame:
    At End of treatment (up to 12 weeks) (LOCF)
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    Safety Issue:
    No
  • Nominal change from baseline in inflammatory lesion (IL) count (sum of papules and pustules) per participant at End of treatment (LOCF)
    date_rangeTime Frame:
    Baseline and End of treatment (up to 12 weeks) (LOCF)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percent change from baseline in IL count (sum of papules and pustules) per participant at End of treatment (LOCF)
    date_rangeTime Frame:
    At End of treatment (up to 12 weeks) (LOCF)
    enhanced_encryption
    Safety Issue:
    No
  • 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’.
    date_rangeTime Frame:
    At End of treatment (up to 12 weeks) (LOCF)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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