- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493687
Phase 3 Papulopustular Rosacea Study
A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T5K 1X3
- Stratica Medical Inc
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 3Y1
- Derm Research@888 Inc.
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Manitoba
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Winnepeg, Manitoba, Canada, R3C 1R4
- Dermadvances Research
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Newfoundland and Labrador
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St John's, Newfoundland and Labrador, Canada, A1A 5E8
- Nexus Clinical Research
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1Z4
- Eastern Canada Cutaneous Research Associates
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Ontario
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Peterborough, Ontario, Canada, K9J 1Z2
- SKiN Centre for Dermatology
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Toronto, Ontario, Canada, M3H 5Y8
- Toronto Research Centre, Inc.
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Windsor, Ontario, Canada, N8W 5L7
- Windsor Clinical Research, Inc.
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Quebec
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Montreal, Quebec, Canada, H2K 4L5
- Innovaderm Research. Inc
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Montreal, Quebec, Canada, H3Z 2S6
- Siena Medical
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Alabama
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Birmingham, Alabama, United States, 35233
- UAB Dermatology Clinical Research
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Arkansas
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Rogers, Arkansas, United States, 72758
- Northwest AR Clinical Trials Center
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California
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Los Angeles, California, United States, 30127
- Dermatology Research Associates
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San Diego, California, United States, 92123
- University Clinical Trials
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Santa Ana, California, United States, 92705
- Research Across America
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Colorado
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Denver, Colorado, United States, 80209
- Cherry Creek Research, Inc.
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Florida
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Aventura, Florida, United States, 33180
- The Center for Clinical & Cosmetic Research
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Boca Raton, Florida, United States, 33486
- The Dermatology and Aesthetic Center
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Jacksonville, Florida, United States, 32204
- North Florida Dermatology Associates
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Miramar, Florida, United States, 33027
- FXM Research Miramar
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Georgia
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Newnan, Georgia, United States, 30263
- MedaPhase, Inc.
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Indiana
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Carmel, Indiana, United States, 46032
- Laser & Skin Surgery Center of Indiana
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Plainfield, Indiana, United States, 46168
- The Indiana Clinical Trials Center
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South Bend, Indiana, United States, 46617
- The South Bend Clinic, LLP
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Kentucky
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Louisville, Kentucky, United States, 40217
- Derm Research, PLLC
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Maryland
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Rockville, Maryland, United States, 20850
- Lawrence Green, MD, LLC
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health Systems Department of Dermatology
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Warren, Michigan, United States, 48088
- Grekin Skin Institute
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Missouri
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Saint Louis, Missouri, United States, 63117
- Central Dermatology PC
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Nebraska
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Omaha, Nebraska, United States, 68144
- Skin Specialists, PC
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New Jersey
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Edison, New Jersey, United States, 08817
- Anderson & Collins Clinical Research,
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North Carolina
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Charlotte, North Carolina, United States, 28277
- PMG Research of Charlotte
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Raleigh, North Carolina, United States, 27612
- Wake Research Associates
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Winston-Salem, North Carolina, United States, 27157
- Department of Dermatology - Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, United States, 45220
- Dermatology Research Center of Cincinnati
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South Euclid, Ohio, United States, 44118
- Haber Dermatology Clinical Research Center
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Oklahoma
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Norman, Oklahoma, United States, 73071
- Central Sooner Research
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Oregon
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Lake Oswego, Oregon, United States, 97035
- Baker Allergy, Asthma and Dermatology Research Center
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South Carolina
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Mount Pleasant, South Carolina, United States, 29464
- PMG Research of Charleston
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Simpsonville, South Carolina, United States, 29681
- Palmetto Clinical Trial Services, LLC
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Tennessee
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Johnson City, Tennessee, United States, 37604
- TriCities Skin and Cancer
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Kingsport, Tennessee, United States, 37660
- Dermatology Associates of Kingsport, PC
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Texas
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Austin, Texas, United States, 78759
- Dermresearch, Inc.
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Dallas, Texas, United States, 75231
- Modern Research Associates
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Houston, Texas, United States, 77030
- Center for Clinical Studies
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San Antonio, Texas, United States, 78229
- Progressive Clinical Research
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Utah
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Salt Lake City, Utah, United States, 84117
- Dermatology Research Center, Inc.
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Virginia
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Lynchburg, Virginia, United States, 24501
- The Education & Research Foundation, Inc.
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Washington
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Seattle, Washington, United States, 98122
- The Polyclinic
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Seattle, Washington, United States, 98101
- PLLC dba Dermatology Associates
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
- The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Exclusion Criteria:
- The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
- The subject has rosacea with more than two nodules on the face.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CD5024
CD5024 1% Cream
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CD5024 1% Cream, once daily
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Placebo Comparator: CD5024 Vehicle
CD5024 Vehicle Cream
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Topical Gel applied twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success Rate
Time Frame: Week 12
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Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale: Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema) |
Week 12
|
Absolute Change in Inflammatory Lesion Count
Time Frame: Baseline to Week 12
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Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator.
Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
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Baseline to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Time Frame: Baseline to Week 12
|
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator.
Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
|
Baseline to Week 12
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD.06.SPR.18170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on CD5024
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-
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-
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-
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