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
688
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
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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 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 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
1.7 years
December 14, 2011
January 8, 2015
February 16, 2021
Conditions
Keywords
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)
Total Skin and Beauty
Birmingham, Alabama, 35205, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Dermatology Specialists, Inc
Oceanside, California, 92056, United States
Integrated Research Group, Inc
Riverside, California, 92506, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
University of California, San Francisco
San Francisco, California, 94143, United States
ATS Clinical Research
Santa Monica, California, 90404, United States
Redwood Dermatology Research
Santa Rosa, California, 95403, United States
FXM Research Corp Miami
Miami, Florida, 33175, United States
Leavitt Medical Associates of Florida dba Ameriderm Research
Ormond Beach, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022, United States
Emory University
Atlanta, Georgia, 30322, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Northwestern University
Chicago, Illinois, 60611, United States
Deaconess Clinic, Inc.
Evansville, Indiana, 47713, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
Dermatology Specialists Research
Louisville, Kentucky, 40202, United States
Northeast Dermatology Associates
Beverly, Massachusetts, 01915, United States
David Fivenson, MD, PLC
Ann Arbor, Michigan, 48103, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Somerset Skin Centre
Troy, Michigan, 48084, United States
Dermatology Clinical Trials Unit
St Louis, Missouri, 63141, United States
Psoriasis Treatment Center of NJ
West Windsor, New Jersey, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
DermResearch Center of New York, Inc
Stony Brook, New York, 11790, United States
Unknown Facility
High Point, North Carolina, 27262, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, 19341, United States
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, 19034, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Paddington Research
Philadelphia, Pennsylvania, 19103, United States
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067, United States
The Skin Wellness Center
Knoxville, Tennessee, 37922, United States
Dermatology Reserach Associates
Nashville, Tennessee, 17203, United States
Arlington Research Center, Inc
Arlington, Texas, 76011, United States
Stephen Miller MD
San Antonio, Texas, 78229, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7, Canada
Ultranova Skincare
Barrie, Ontario, L4M 6L2, Canada
Dermatrials Research
Hamilton, Ontario, L8N 1V6, Canada
The Guenther Dermatology Research Center
London, Ontario, N6A 3H7, Canada
Lynderm Research Inc
Markham, Ontario, L3P 1A8, Canada
North Bay Dermatology Centre, Inc
North Bay, Ontario, P1B 3Z7, Canada
The Centre for Dermatology & Cosmetic Surgery
Richmond Hill, Ontario, L4B 1A5, Canada
XLR8 Medical Research, Inc
Windsor, Ontario, N8W 1E6, Canada
International Dermatology Research, Inc
Montreal, Quebec, H3H 1V4, Canada
Centre de Recherche Dermatologique du Quebec Metropolitan
Québec, Quebec, G1V 4X7, 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 19, 2011
Study Start
December 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
February 18, 2021
Results First Posted
January 16, 2015
Record last verified: 2015-01