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

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

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.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: CD07805/47 Gel; Drug: CD07805/47 Gel; Drug: CD07805/47 Gel; Drug: Vehicle Gel; Drug: Vehicle Gel

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • San Francisco, California, United States, 94143-0660
      • University of California at San Francisco
  • Georgia
    • Newnan, Georgia, United States, 30263
      • Meda Phase, Inc
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists PC
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology, PC
  • New York
    • New York, New York, United States, 10021
      • Skin Specialty Group
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology Laser & Vein Specialists
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology & Research Center
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • Philadelphia Institute of Dermatology
    • Hazleton, Pennsylvania, United States, 18201
      • DermDox
  • South Carolina
    • Greenville, South Carolina, United States, 29007
      • Palmetto Clinical Trial Services, LLC
  • Tennessee
    • Knoxville, Tennessee, United States, 37902
      • The Skin Wellness Center
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment & Research Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education & Research Foundation
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD07805/47 Gel 0.5% QD	Drug: CD07805/47 Gel; CD07805/47 Gel 0.5% QD; Drug: CD07805/47 Gel; CD07805/47 Gel 0.18% QD; Drug: CD07805/47 Gel; CD07805/47 Gel 0.18% BID
Experimental: CD07805/47 Gel 0.18% QD	Drug: CD07805/47 Gel; CD07805/47 Gel 0.5% QD; Drug: CD07805/47 Gel; CD07805/47 Gel 0.18% QD; Drug: CD07805/47 Gel; CD07805/47 Gel 0.18% BID
Experimental: CD07805/47 Gel 0.18% BID	Drug: CD07805/47 Gel; CD07805/47 Gel 0.5% QD; Drug: CD07805/47 Gel; CD07805/47 Gel 0.18% QD; Drug: CD07805/47 Gel; CD07805/47 Gel 0.18% BID
Placebo Comparator: Vehicle Gel QD	Drug: Vehicle Gel; Vehicle Gel QD; Drug: Vehicle Gel; Vehicle Gel BID
Placebo Comparator: Vehicle Gel BID	Drug: Vehicle Gel; Vehicle Gel QD; Drug: Vehicle Gel; Vehicle Gel BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 29
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	day 29

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Dow Stough, MD, Burke Pharmaceutical Research; Principal Investigator: William Werschler, MD, Premier Clinical Research; Principal Investigator: Steven Kempers, MD, Minnesota Clinical Study Center; Principal Investigator: Angela Moore, MD, Arlington Center for Dermatology; Principal Investigator: Stephen Schleicher, MD, DermDox; Principal Investigator: Patricia Westmoreland, MD, Palmetto Clinical Trial Services, LLC; Principal Investigator: William Abramovits, MD, Dermatology Treatment & Research Center; Principal Investigator: Zoe Draelos, MD, Dermatology Consulting Services, High Point NC; Principal Investigator: Kimberly Grande, MD, The Skin Wellness Center; Principal Investigator: Andrew Pollack, MD, Philadelphia Institute of Dermatology; Study Director: Michael Graeber, MD, Galderma R&D, Inc; Principal Investigator: Fran Cook-Bolden, MD, Skin Specialty Group; Principal Investigator: Joseph Fowler, MD, Dermatology Specialists, PSC; Principal Investigator: Michael Heffernan, MD, Central Dermatology PC; 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: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: August 2, 2010
• First Posted (Estimate): August 3, 2010

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Rosacea; Erythema
• Other Study ID Numbers: RD.06.SPR.18161