Phase 3 Papulopustular Rosacea Study

Completed · Phase 3

Conditions studied: Papulopustular Rosacea

In brief

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.

Key facts

Study ID

NCT01494467

Run by

Galderma R&D

People needed

688

Starts

2011-12-01

Expected to finish

2013-08-01

Last updated by the study team

2021-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Total Skin and Beauty — Birmingham, Alabama, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• Dermatology Specialists, Inc — Oceanside, California, United States
• Integrated Research Group, Inc — Riverside, California, United States
• Therapeutics Clinical Research — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• ATS Clinical Research — Santa Monica, California, United States
• Redwood Dermatology Research — Santa Rosa, California, United States
• FXM Research Corp Miami — Miami, Florida, United States
• Leavitt Medical Associates of Florida dba Ameriderm Research — Ormond Beach, Florida, United States
• Atlanta Dermatology, Vein & Research Center, LLC — Alpharetta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Northwestern University — Chicago, Illinois, United States
• Deaconess Clinic, Inc. — Evansville, Indiana, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Dermatology Specialists Research — Louisville, Kentucky, United States
• Northeast Dermatology Associates — Beverly, Massachusetts, United States
• David Fivenson, MD, PLC — Ann Arbor, Michigan, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Somerset Skin Centre — Troy, Michigan, United States
• Dermatology Clinical Trials Unit — St Louis, Missouri, United States
• Psoriasis Treatment Center of NJ — West Windsor, New Jersey, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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