Clinical trial NCT01174030: Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-08-03
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.


Eligibility 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.

Primary outcomes:
measure: Composite Success
timeFrame: Day 29
Secondary outcomes:
measure: CEA Success
timeFrame: Day 29
measure: PSA-5 Success
timeFrame: day 29
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Newnan
country: United States
facility: Meda Phase, Inc
state: Georgia
city: Louisville
country: United States
facility: Dermatology Specialists PC
state: Kentucky
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology, PC
state: Missouri
city: New York
country: United States
facility: Skin Specialty Group
state: New York
city: Charlotte
country: United States
facility: Dermatology Laser & Vein Specialists
state: North Carolina
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research
state: Oregon
city: Fort Washington
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Hazleton
country: United States
facility: DermDox
state: Pennsylvania
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center for Dermatology
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Madison
country: United States
facility: Madison Skin & Research
state: Wisconsin
Study officials:
affiliation: Galderma R&D, Inc
name: Michael Graeber, MD
role: STUDY_DIRECTOR
affiliation: Dermatology Treatment & Research Center
name: William Abramovits, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Specialty Group
name: Fran Cook-Bolden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Consulting Services, High Point NC
name: Zoe Draelos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists, PSC
name: Joseph Fowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Skin Wellness Center
name: Kimberly Grande, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Dermatology PC
name: Michael Heffernan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Clinical Study Center
name: Steven Kempers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meda Phase, Inc.
name: Mark Ling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Medical Research
name: Robert Matheson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Education & Research Foundation
name: Kappa Meadows, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arlington Center for Dermatology
name: Angela Moore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology, Laser & Vein Specialists of the Carolinas
name: Girish Munavalli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Philadelphia Institute of Dermatology
name: Andrew Pollack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Dermatology & Research Center
name: Phoebe Rich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Madison Skin & Research
name: Harry Sharta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California at San Francisco
name: Martin Steinhoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Burke Pharmaceutical Research
name: Dow Stough, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Clinical Research
name: William Werschler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Palmetto Clinical Trial Services, LLC
name: Patricia Westmoreland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DermDox
name: Stephen Schleicher, MD
role: PRINCIPAL_INVESTIGATOR
References: