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.
1 other identifier
interventional
683
2 countries
50
Brief Summary
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2011
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 14, 2011
CompletedFirst Posted
Study publicly available on registry
December 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
January 16, 2015
CompletedFebruary 18, 2021
January 1, 2015
1.6 years
December 14, 2011
January 8, 2015
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Success Rate
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
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
Secondary Outcomes (1)
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Baseline to Week 12
Study Arms (2)
CD5024
EXPERIMENTALCD5024 1% Cream
CD5024 Vehicle
PLACEBO COMPARATORCD5024 Vehicle Cream
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (50)
UAB Dermatology Clinical Research
Birmingham, Alabama, 35233, United States
Northwest AR Clinical Trials Center
Rogers, Arkansas, 72758, United States
Dermatology Research Associates
Los Angeles, California, 30127, United States
University Clinical Trials
San Diego, California, 92123, United States
Research Across America
Santa Ana, California, 92705, United States
Cherry Creek Research, Inc.
Denver, Colorado, 80209, United States
The Center for Clinical & Cosmetic Research
Aventura, Florida, 33180, United States
The Dermatology and Aesthetic Center
Boca Raton, Florida, 33486, United States
North Florida Dermatology Associates
Jacksonville, Florida, 32204, United States
FXM Research Miramar
Miramar, Florida, 33027, United States
MedaPhase, Inc.
Newnan, Georgia, 30263, United States
Laser & Skin Surgery Center of Indiana
Carmel, Indiana, 46032, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, 46168, United States
The South Bend Clinic, LLP
South Bend, Indiana, 46617, United States
Derm Research, PLLC
Louisville, Kentucky, 40217, United States
Lawrence Green, MD, LLC
Rockville, Maryland, 20850, United States
Henry Ford Health Systems Department of Dermatology
Detroit, Michigan, 48202, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
Central Dermatology PC
St Louis, Missouri, 63117, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Anderson & Collins Clinical Research,
Edison, New Jersey, 08817, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28277, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Department of Dermatology - Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Dermatology Research Center of Cincinnati
Cincinnati, Ohio, 45220, United States
Haber Dermatology Clinical Research Center
South Euclid, Ohio, 44118, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
Baker Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, 97035, United States
PMG Research of Charleston
Mt. Pleasant, South Carolina, 29464, United States
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, 29681, United States
TriCities Skin and Cancer
Johnson City, Tennessee, 37604, United States
Dermatology Associates of Kingsport, PC
Kingsport, Tennessee, 37660, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Modern Research Associates
Dallas, Texas, 75231, United States
Center for Clinical Studies
Houston, Texas, 77030, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501, United States
PLLC dba Dermatology Associates
Seattle, Washington, 98101, United States
The Polyclinic
Seattle, Washington, 98122, United States
Stratica Medical Inc
Edmonton, Alberta, T5K 1X3, Canada
Derm Research@888 Inc.
Vancouver, British Columbia, V5Z 3Y1, Canada
Dermadvances Research
Winnepeg, Manitoba, R3C 1R4, Canada
Nexus Clinical Research
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Eastern Canada Cutaneous Research Associates
Halifax, Nova Scotia, B3H 1Z4, Canada
Skin Centre for Dermatology
Peterborough, Ontario, K9J 1Z2, Canada
Toronto Research Centre, Inc.
Toronto, Ontario, M3H 5Y8, Canada
Windsor Clinical Research, Inc.
Windsor, Ontario, N8W 5L7, Canada
Innovaderm Research. Inc
Montreal, Quebec, H2K 4L5, Canada
Siena Medical
Montreal, Quebec, H3Z 2S6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Science Director
- Organization
- Galderma R&D, LLC
Study Officials
- STUDY DIRECTOR
Michael Graeber, M.D.
Galderma R&D, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2011
First Posted
December 16, 2011
Study Start
December 1, 2011
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
February 18, 2021
Results First Posted
January 16, 2015
Record last verified: 2015-01