Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
NCT ID: NCT01174030
Last Updated: 2021-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
269 participants
INTERVENTIONAL
2010-08-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CD07805/47 Gel 0.5% QD
CD07805/47 Gel
CD07805/47 Gel 0.5% QD
CD07805/47 Gel 0.18% QD
CD07805/47 Gel
CD07805/47 Gel 0.18% QD
CD07805/47 Gel 0.18% BID
CD07805/47 Gel
CD07805/47 Gel 0.18% BID
Vehicle Gel QD
Vehicle Gel
Vehicle Gel QD
Vehicle Gel BID
Vehicle Gel
Vehicle Gel BID
Interventions
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CD07805/47 Gel
CD07805/47 Gel 0.5% QD
Vehicle Gel
Vehicle Gel QD
CD07805/47 Gel
CD07805/47 Gel 0.18% QD
CD07805/47 Gel
CD07805/47 Gel 0.18% BID
Vehicle Gel
Vehicle Gel BID
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Graeber, MD
Role: STUDY_DIRECTOR
Galderma R&D, Inc
William Abramovits, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Treatment & Research Center
Fran Cook-Bolden, MD
Role: PRINCIPAL_INVESTIGATOR
Skin Specialty Group
Zoe Draelos, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Consulting Services, High Point NC
Joseph Fowler, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Specialists, PSC
Kimberly Grande, MD
Role: PRINCIPAL_INVESTIGATOR
The Skin Wellness Center
Michael Heffernan, MD
Role: PRINCIPAL_INVESTIGATOR
Central Dermatology PC
Steven Kempers, MD
Role: PRINCIPAL_INVESTIGATOR
Minnesota Clinical Study Center
Mark Ling, MD
Role: PRINCIPAL_INVESTIGATOR
Meda Phase, Inc.
Robert Matheson, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Medical Research
Kappa Meadows, MD
Role: PRINCIPAL_INVESTIGATOR
The Education & Research Foundation
Angela Moore, MD
Role: PRINCIPAL_INVESTIGATOR
Arlington Center for Dermatology
Girish Munavalli, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology, Laser & Vein Specialists of the Carolinas
Andrew Pollack, MD
Role: PRINCIPAL_INVESTIGATOR
Philadelphia Institute of Dermatology
Phoebe Rich, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Dermatology & Research Center
Harry Sharta, MD
Role: PRINCIPAL_INVESTIGATOR
Madison Skin & Research
Martin Steinhoff, MD
Role: PRINCIPAL_INVESTIGATOR
University of California at San Francisco
Dow Stough, MD
Role: PRINCIPAL_INVESTIGATOR
Burke Pharmaceutical Research
William Werschler, MD
Role: PRINCIPAL_INVESTIGATOR
Premier Clinical Research
Patricia Westmoreland, MD
Role: PRINCIPAL_INVESTIGATOR
Palmetto Clinical Trial Services, LLC
Stephen Schleicher, MD
Role: PRINCIPAL_INVESTIGATOR
DermDox
Locations
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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
Countries
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Other Identifiers
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RD.06.SPR.18161
Identifier Type: -
Identifier Source: org_study_id
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