Back to resultsEfficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CD07805/47 Gel
Vehicle Gel
CD07805/47 Gel
CD07805/47 Gel
Vehicle Gel
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Burke Pharmaceutical Research
- University of California at San Francisco
- Meda Phase, Inc
- Dermatology Specialists PC
- Minnesota Clinical Study Center
- Central Dermatology, PC
- Skin Specialty Group
- Dermatology Laser & Vein Specialists
- Dermatology Consulting Services
- Oregon Dermatology & Research Center
- Oregon Medical Research
- Philadelphia Institute of Dermatology
- DermDox
- Palmetto Clinical Trial Services, LLC
- The Skin Wellness Center
- Arlington Center for Dermatology
- Dermatology Treatment & Research Center
- The Education & Research Foundation
- Premier Clinical Research
- Madison Skin & Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
CD07805/47 Gel 0.5% QD
CD07805/47 Gel 0.18% QD
CD07805/47 Gel 0.18% BID
Vehicle Gel QD
Vehicle Gel BID
Arm Description
Outcomes
Primary Outcome Measures
Composite Success
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Secondary Outcome Measures
CEA Success
CEA success defined as 2-grade improvement on CEA.
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
/ Amost clear; slight redness
/ Mild erythema; definite redness
/ Moderate erythema; marked redness
/ Severe erythema; fiery redness
PSA-5 Success
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
PSA-5 success defined as 2-grade improvement on PSA-5.
Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness
/ Very mild redness
/ Mild redness
/ Moderate redness
/ Severe redness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01174030
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CD07805/47 Gel 0.5% QD
Arm Type
Experimental
Arm Title
CD07805/47 Gel 0.18% QD
Arm Type
Experimental
Arm Title
CD07805/47 Gel 0.18% BID
Arm Type
Experimental
Arm Title
Vehicle Gel QD
Arm Type
Placebo Comparator
Arm Title
Vehicle Gel BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CD07805/47 Gel
Intervention Description
CD07805/47 Gel 0.5% QD
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Intervention Description
Vehicle Gel QD
Intervention Type
Drug
Intervention Name(s)
CD07805/47 Gel
Intervention Description
CD07805/47 Gel 0.18% QD
Intervention Type
Drug
Intervention Name(s)
CD07805/47 Gel
Intervention Description
CD07805/47 Gel 0.18% BID
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Intervention Description
Vehicle Gel BID
Primary Outcome Measure Information:
Title
Composite Success
Description
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5).
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
CEA Success
Description
CEA success defined as 2-grade improvement on CEA.
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema
/ Amost clear; slight redness
/ Mild erythema; definite redness
/ Moderate erythema; marked redness
/ Severe erythema; fiery redness
Time Frame
Day 29
Title
PSA-5 Success
Description
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
PSA-5 success defined as 2-grade improvement on PSA-5.
Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness
/ Very mild redness
/ Mild redness
/ Moderate redness
/ Severe redness
Time Frame
day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, MD
Organizational Affiliation
Galderma R&D, Inc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
William Abramovits, MD
Organizational Affiliation
Dermatology Treatment & Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fran Cook-Bolden, MD
Organizational Affiliation
Skin Specialty Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zoe Draelos, MD
Organizational Affiliation
Dermatology Consulting Services, High Point NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Fowler, MD
Organizational Affiliation
Dermatology Specialists, PSC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly Grande, MD
Organizational Affiliation
The Skin Wellness Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Heffernan, MD
Organizational Affiliation
Central Dermatology PC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steven Kempers, MD
Organizational Affiliation
Minnesota Clinical Study Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Ling, MD
Organizational Affiliation
Meda Phase, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Matheson, MD
Organizational Affiliation
Oregon Medical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kappa Meadows, MD
Organizational Affiliation
The Education & Research Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela Moore, MD
Organizational Affiliation
Arlington Center for Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Girish Munavalli, MD
Organizational Affiliation
Dermatology, Laser & Vein Specialists of the Carolinas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Pollack, MD
Organizational Affiliation
Philadelphia Institute of Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phoebe Rich, MD
Organizational Affiliation
Oregon Dermatology & Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry Sharta, MD
Organizational Affiliation
Madison Skin & Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Steinhoff, MD
Organizational Affiliation
University of California at San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dow Stough, MD
Organizational Affiliation
Burke Pharmaceutical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Werschler, MD
Organizational Affiliation
Premier Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Westmoreland, MD
Organizational Affiliation
Palmetto Clinical Trial Services, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Schleicher, MD
Organizational Affiliation
DermDox
Official's Role
Principal Investigator
Facility Information:
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0660
Country
United States
Facility Name
Meda Phase, Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Dermatology Specialists PC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Central Dermatology, PC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Skin Specialty Group
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Dermatology Laser & Vein Specialists
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Oregon Dermatology & Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Medical Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Philadelphia Institute of Dermatology
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
DermDox
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
Palmetto Clinical Trial Services, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29007
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37902
Country
United States
Facility Name
Arlington Center for Dermatology
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Dermatology Treatment & Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
The Education & Research Foundation
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Madison Skin & Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea
We'll reach out to this number within 24 hrs