Status:
COMPLETED
Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Lead Sponsor:
Galderma R&D
Conditions:
Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 onc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT01174030
Start Date
August 1 2010
End Date
January 1 2011
Last Update
February 26 2021
Active Locations (20)
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1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
2
University of California at San Francisco
San Francisco, California, United States, 94143-0660
3
Meda Phase, Inc
Newnan, Georgia, United States, 30263
4
Dermatology Specialists PC
Louisville, Kentucky, United States, 40202