Study 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

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

Trial summary

Enrollment Goal

401

Trial Dates

December 2009 - August 2010

Phase

Phase 2

Could I Receive a placebo

Products

Finacea® (azelaic acid) Foam, 15% (Azelaic Acid, BAY39-6251)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Research Across America	Plano, 75093, United States
Completed	Center for Dermatology Clinical Research	Fremont, 94538, United States
Completed	New Hanover Medical Research	Wilmington, 28401, United States
Completed	Dermatology Consulting Services	High Point, 27262, United States
Completed	University of Alabama- Birmingham	Birmingham, 35233, United States
Completed	FXM Research Miramar	Miramar, 33027, United States
Completed	Clinical Partners, LLC	Johnston, 02919, United States
Completed	Tennessee Clinical Research	Nashville, 37215, United States
Completed	The Skin Wellness Center	Knoxville, 37922, United States
Completed	Radiant Research	Birmingham, 35209, United States
Completed	Derm Research	Austin, 78759, United States
Completed	Piedmont Research Association Inc.	Winston Salem, 27103, United States
Completed	Oregon Dermatology & Research Center	Portland, 97210, United States
Completed		Omaha, 68144, United States
Completed	Madison Skin & Research Center	Madison, 53719, United States
Completed	Dermatology Research Center	Salt Lake City, 84124, United States
Completed	Academic Dermatology Associates	Albuquerque, 87106, United States
Completed	Palmetto Clinical Trial Services, LLC	Simpsonville, 29681, United States
Completed	FXM Research Corporation	Miami, 33175, United States
Completed	Clinical Science Institute	Santa 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.
Time Frame:
At End of treatment (up to 12 weeks) (LOCF)
Safety Issue:
No
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)
Safety Issue:
No

Secondary Outcome

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)
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’.
Time Frame:
At End of treatment (up to 12 weeks) (LOCF)
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

Additional Information

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