Trial Condition(s):
Papulopustular Rosacea
Safety and efficacy of Azelaic Acid Foam, 15% in papulopustular rosacea
Bayer Identifier:
14955
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Research Across America Plano, United States, 75093 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center for Dermatology Clinical Research Fremont, United States, 94538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Hanover Medical Research Wilmington, United States, 28401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatology Consulting Services High Point, United States, 27262 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Alabama- Birmingham Birmingham, United States, 35233 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations FXM Research Miramar Miramar, United States, 33027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Partners, LLC Johnston, United States, 02919 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tennessee Clinical Research Nashville, United States, 37215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Skin Wellness Center Knoxville, United States, 37922 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Radiant Research Birmingham, United States, 35209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Derm Research Austin, United States, 78759 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Piedmont Research Association Inc. Winston Salem, United States, 27103 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oregon Dermatology & Research Center Portland, United States, 97210 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Omaha, United States, 68144 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Madison Skin & Research Center Madison, United States, 53719 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dermatology Research Center Salt Lake City, United States, 84124 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academic Dermatology Associates Albuquerque, United States, 87106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Palmetto Clinical Trial Services, LLC Simpsonville, United States, 29681 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations FXM Research Corporation Miami, United States, 33175 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Science Institute Santa Monica, United States, 90404 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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.Timeframe: 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)Timeframe: Baseline and End of treatment (up to 12 weeks) (LOCF)
Secondary Outcome
- Percent change from baseline in IL count (sum of papules and pustules) per participant at End of treatment (LOCF)Timeframe: 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)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’.Timeframe: At End of treatment (up to 12 weeks) (LOCF)
Additional Information
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