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

Sponsor:	Galderma
Information provided by (Responsible Party):	Galderma
ClinicalTrials.gov Identifier:	NCT01174030

Purpose

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.

Condition	Intervention	Phase
Rosacea	Drug: CD07805/47 Gel Drug: Vehicle Gel	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

Composite success [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).

Secondary Outcome Measures:

CEA Success [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
CEA success defined as 2-grade improvement on CEA.
PSA-5 success [ Time Frame: day 29 ] [ Designated as safety issue: No ]

Enrollment:	269
Study Start Date:	August 2010
Study Completion Date:	January 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CD07805/47 Gel 0.5% QD	Drug: CD07805/47 Gel CD07805/47 Gel 0.5% QD;
Experimental: CD07805/47 Gel 0.18% QD	Drug: CD07805/47 Gel CD07805/47 Gel 0.18% QD
Experimental: CD07805/47 Gel 0.18% BID	Drug: CD07805/47 Gel CD07805/47 Gel 0.18% BID
Placebo Comparator: Vehicle Gel QD	Drug: Vehicle Gel Vehicle Gel QD
Placebo Comparator: Vehicle Gel BID	Drug: Vehicle Gel Vehicle Gel BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01174030

Show 20 Study Locations

Sponsors and Collaborators

Galderma

Investigators

Study Director:	Michael Graeber, MD	Galderma R&D, Inc
Principal Investigator:	William Abramovits, MD	Dermatology Treatment & Research Center
Principal Investigator:	Fran Cook-Bolden, MD	Skin Specialty Group
Principal Investigator:	Zoe Draelos, MD	Dermatology Consulting Services
Principal Investigator:	Joseph Fowler, MD	Dermatology Specialists, PSC
Principal Investigator:	Kimberly Grande, MD	The Skin Wellness Center
Principal Investigator:	Michael Heffernan, MD	Central Dermatology PC
Principal Investigator:	Steven Kempers, MD	Minnesota Clinical Study Center
Principal Investigator:	Mark Ling, MD	Meda Phase, Inc.
Principal Investigator:	Robert Matheson, MD	Oregon Medical Research
Principal Investigator:	Kappa Meadows, MD	The Education & Research Foundation
Principal Investigator:	Angela Moore, MD	Arlington Center for Dermatology
Principal Investigator:	Girish Munavalli, MD	Dermatology Laser & Vein Specialists of the Carolinas
Principal Investigator:	Andrew Pollack, MD	Philadelphia Institute of Dermatology
Principal Investigator:	Phoebe Rich, MD	Oregon Dermatology & Research Center
Principal Investigator:	Harry Sharta, MD	Madison Skin & Research
Principal Investigator:	Martin Steinhoff, MD	University of California at San Francisco
Principal Investigator:	Dow Stough, MD	Burke Pharmaceutical Research
Principal Investigator:	William Werschler, MD	Premier Clinical Research
Principal Investigator:	Patricia Westmoreland, MD	Palmetto Clinical Trial Services, LLC
Principal Investigator:	Stephen Schleicher, MD	DermDox

More Information

No publications provided

Responsible Party:	Galderma
ClinicalTrials.gov Identifier:	NCT01174030 History of Changes
Other Study ID Numbers:	RD.06.SPR.18161
Study First Received:	July 30, 2010
Last Updated:	January 10, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rosacea
Erythema
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012