Phase 3 Papulopustular Rosacea Study

Completed · Phase 3

Conditions studied: Papulopustular Rosacea (PPR)

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

NCT01493687

Run by

Galderma R&D

People needed

683

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

• UAB Dermatology Clinical Research — Birmingham, Alabama, United States
• Northwest AR Clinical Trials Center — Rogers, Arkansas, United States
• Dermatology Research Associates — Los Angeles, California, United States
• University Clinical Trials — San Diego, California, United States
• Research Across America — Santa Ana, California, United States
• Cherry Creek Research, Inc. — Denver, Colorado, United States
• The Center for Clinical & Cosmetic Research — Aventura, Florida, United States
• The Dermatology and Aesthetic Center — Boca Raton, Florida, United States
• North Florida Dermatology Associates — Jacksonville, Florida, United States
• FXM Research Miramar — Miramar, Florida, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Laser & Skin Surgery Center of Indiana — Carmel, Indiana, United States
• The Indiana Clinical Trials Center — Plainfield, Indiana, United States
• The South Bend Clinic, LLP — South Bend, Indiana, United States
• Derm Research, PLLC — Louisville, Kentucky, United States
• Lawrence Green, MD, LLC — Rockville, Maryland, United States
• Henry Ford Health Systems Department of Dermatology — Detroit, Michigan, United States
• Grekin Skin Institute — Warren, Michigan, United States
• Central Dermatology PC — St Louis, Missouri, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Anderson & Collins Clinical Research, — Edison, New Jersey, United States
• PMG Research of Charlotte — Charlotte, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Department of Dermatology - Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Dermatology Research Center of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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