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

Completed · Phase 2

Conditions studied: Rosacea

In brief

The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.

Key facts

Study ID

NCT01174030

Run by

Galderma R&D

People needed

269

Starts

2010-08-01

Expected to finish

2011-01-01

Last updated by the study team

2021-02-26

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 rosacea.
• A Clinician Erythema Assessment (CEA) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
• A Patient Self Assessment-5 (PSA-5) score of 3 at Screening and at Pre-dose (T0) on Baseline/Day 1.
• A Patient Self Assessment-11 (PSA-11) score of 5 at Screening and at Pre-dose (T0) on Baseline/Day 1.

You may not qualify if…

• Three (3) or more facial inflammatory lesions.
• 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.
• Known allergies or sensitivities to any components of the study medications, including the active gel ingredient, brimonidine tartrate.
• Intraocular pressure (IOP) measurement less than 10 mm Hg.

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States
• University of California at San Francisco — San Francisco, California, United States
• Meda Phase, Inc — Newnan, Georgia, United States
• Dermatology Specialists PC — Louisville, Kentucky, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Central Dermatology, PC — St Louis, Missouri, United States
• Skin Specialty Group — New York, New York, United States
• Dermatology Laser & Vein Specialists — Charlotte, North Carolina, United States
• Dermatology Consulting Services — High Point, North Carolina, United States
• Oregon Dermatology & Research Center — Portland, Oregon, United States
• Oregon Medical Research — Portland, Oregon, United States
• Philadelphia Institute of Dermatology — Fort Washington, Pennsylvania, United States
• DermDox — Hazleton, Pennsylvania, United States
• Palmetto Clinical Trial Services, LLC — Greenville, South Carolina, United States
• The Skin Wellness Center — Knoxville, Tennessee, United States
• Arlington Center for Dermatology — Arlington, Texas, United States
• Dermatology Treatment & Research Center — Dallas, Texas, United States
• The Education & Research Foundation — Lynchburg, Virginia, United States
• Premier Clinical Research — Spokane, Washington, United States
• Madison Skin & Research — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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