Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

A Multicenter, Randomized Double-Blind, Vehicle-Controlled, Parallel Group Study to Demonstrate the Efficacy and Safety of CD07805/47 Gel Applied Topically Once Daily in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Placebo; Drug: CD07805/47 gel

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada, L3P 1A8
      • Lynderm Research Inc
    • Windsor, Ontario, Canada, N8W 5L7
      • Windsor Clinical Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research, Inc
• United States
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Skin Care Research
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Windsor Dermatology
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Dermatology Consulting Services
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Fort Washington, Pennsylvania, United States, 19034
      • Philadelphia Institute of Dermatology
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Dallas, Texas, United States, 72230
      • Dermatology Treatment & Research Center
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education & Research Foundation, Inc.

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

Key Inclusion Criteria:

1. Male or female who is at least 18 years of age or older.
2. A clinical diagnosis of facial rosacea.
3. A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
4. A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).

Key Exclusion Criteria:

1. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
2. Presence of three (3) or more facial inflammatory lesions of rosacea.
3. Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
4. Less than 3 months stable dose treatment with tricyclic antidepressants, cardiac glycosides, beta blockers or other antihypertensive agents.
5. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; applied topically once daily
Experimental: CD07805/47 gel	Drug: CD07805/47 gel; applied topically once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Success	Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).	Day 29

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Chair: Michael Graeber, MD, Galderma R&D; Principal Investigator: Robert Bissonette, MD, Innovaderm Research Inc.; Principal Investigator: Angela Moore, MD, Arlington Center for Dermatology; 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: Charles Lynde, MD, Lynderm Research Inc; Principal Investigator: Kappa Meadows, MD, The Education & Research Foundation, Inc.; Principal Investigator: David Nieves, MD, Windsor Dermatology; Principal Investigator: Andrew Pollack, MD, Philadelphia Institute of Dermatology; Principal Investigator: Howard Sofen, MD, Dermatology Research Associates; Principal Investigator: Martin Steinhoff, MD, University of California, San Francisco; Principal Investigator: Daniel Stewart, DO, Michigan Center for Skin Care Research; Principal Investigator: Jerry Tan, MD, Windsor Clinical Research Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 17, 2011
• First Posted (Estimate): May 18, 2011

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: rosacea
• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Rosacea; Erythema
• Other Study ID Numbers: RD.06.SPR.18140