Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

Completed · Phase 3

Conditions studied: Rosacea

In brief

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Key facts

Study ID

NCT01318733

Run by

Galderma R&D

People needed

449

Starts

2011-03-01

Expected to finish

2012-07-01

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…

• Male or female who is at least 18 years of age or older.
• A clinical diagnosis of facial rosacea.
• A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
• A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

You may not qualify if…

• Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
• Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
• Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
• Current treatment with monoamine oxidase (MAO) inhibitors.
• Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
• Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

Where it is running

• The Laser Institute for Dermatology — Santa Monica, California, United States
• Cherry Creek Research, Inc — Denver, Colorado, United States
• Longmont Clinical PC — Longmont, Colorado, United States
• Gwinnett Clinical Research Center, Inc — Snellville, Georgia, United States
• Deaconess Clinic — Evansville, Indiana, United States
• Compliant Clinical Research — Olathe, Kansas, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Dermcenter PC- Somerset Skin Centre — Troy, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• DermResearch Center of New York, Inc — Stony Brook, New York, United States
• Metrolina Medical Research — Charlotte, North Carolina, United States
• Dermatology, Laser & Vein Specialists of the Carolinas — Charlotte, North Carolina, United States
• Wilmington Medical Research — Wilmington, North Carolina, United States
• Piedmont Medical Research — Winston-Salem, North Carolina, United States
• DermDox — Hazleton, Pennsylvania, United States
• Palmetto Medical Research — Mt. Pleasant, South Carolina, United States
• Rivergate Dermatology Clinical Research Center, PLLC — Goodlettsville, Tennessee, United States
• East Tennessee Medical Research — Johnson City, Tennessee, United States
• TriCities Medical Research — Kingsport, Tennessee, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Arlington Center for Dermatology — Arlington, Texas, United States
• Dermatology Clinical Research Center of San Antonio — San Antonio, Texas, United States
• Progressive Clinical Research, PA — San Antonio, Texas, United States
• Dermatology Research Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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