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

This is a 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: CD07805/47 Gel; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 293
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T25 3B3
      • Kirk Barber Research Inc.
  • Newfoundland and Labrador
    • St John's, Newfoundland and Labrador, Canada, A1A 5E8
      • Nexus Clinical Research
    • St. John's, Newfoundland and Labrador, Canada, A1C2H5
      • NewLab Clinical Research Inc.
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Baumann Cosmetic and Research Institute
  • Georgia
    • Newnan, Georgia, United States, 30263
      • MedaPhase, Inc.
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research
  • Michigan
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Central Dermatology PC
  • New York
    • New York, New York, United States, 10155
      • Skin Specialty Dermatology
  • Ohio
    • South Euclid, Ohio, United States, 44118
      • Haber Dermatology & Cosmetic Surgery
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • Palmetto Clinical Trial Services, LLC
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies Inc.
  • Washington
    • Spokane, Washington, United States, 99201
      • Premier Clinical 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

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: Kirk Barber, MD, Kirk Barber Research Inc.; Principal Investigator: Leslie Baumann, MD, Baumann Cosmetic and Research Institute; Principal Investigator: Fran Cook-Bolden, MD, Skin Specialty Dermatology; Principal Investigator: Steven Grekin, DO, Grekin Skin Institute; Principal Investigator: Wayne Gulliver, MD, NewLab Clinical Research Inc.; Principal Investigator: Robert Haber, MD, Haber Dermatology & Cosmetic Surgery; Principal Investigator: Michael Heffernan, MD, Central Dermatology; Principal Investigator: Ian Landells, MD, Nexus Clinical Research; Principal Investigator: Mark Ling, MD, MedaPhase, Inc.; Principal Investigator: Phoebe Rich, MD, Oregon Dermatology and Research Center; Principal Investigator: Dow Stough, MD, Burke Pharmaceutical Research; Principal Investigator: William Werschler, MD, Premier Clinical Research; Principal Investigator: Patricia Westmoreland, MD, Palmetto Clinical Trials Services, LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): January 1, 2012

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.18141

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No