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

A Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of CD07805/47 Gel 0.5% Applied Topically Once Daily for up to 52 Weeks in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: CD07805/47 gel 0.5%

• Study Type: Interventional
• Enrollment (Actual): 449
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • The Laser Institute for Dermatology
  • Colorado
    • Denver, Colorado, United States, 80209
      • Cherry Creek Research, Inc
    • Longmont, Colorado, United States, 80501
      • Longmont Clinical PC
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research Center, Inc
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Compliant Clinical Research
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Troy, Michigan, United States, 48084
      • Dermcenter PC- Somerset Skin Centre
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New York
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York, Inc
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser & Vein Specialists of the Carolinas
    • Charlotte, North Carolina, United States, 27277
      • Metrolina Medical Research
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Medical Research
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Medical Research
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • DermDox
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Palmetto Medical Research
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Rivergate Dermatology Clinical Research Center, PLLC
    • Johnson City, Tennessee, United States, 37604
      • East Tennessee Medical Research
    • Kingsport, Tennessee, United States, 37660
      • Tricities Medical Research
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Center for Dermatology
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research, PA
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Dermatology Research Center
  • Washington
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Medical Center - Clinical Research Department
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin & Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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 facial rosacea.
• A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
• A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

Exclusion Criteria:

• 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.
• 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.
• Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
• Current treatment with monoamine oxidase (MAO) inhibitors.
• Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
• Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD07805/47 Gel 0.5%	Drug: CD07805/47 gel 0.5%; In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea.	Static evaluation of erythema severity using the Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema; / Almost clear; slight redness; / Mild erythema; definite redness; / Moderate erythema; marked redness; / Severe erythema; fiery redness Change in CEA from Baseline CEA (T0 at Baseline visit Day 1) at T3 of each post-baseline visit, including Day 1.	Over 1 year

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Steven Kempers, MD, Minnesota Clinical Study Center; Principal Investigator: Fasahat Hamzavi, MD, Hamzavi Dermatology; Principal Investigator: Scott Clark, MD, Longmont Clinical PC; Principal Investigator: Lesly Davidson, MD, Palmetto Medical Research; Principal Investigator: Steven Davis, MD, Dermatology Clinical Research Center of San Antonio; Principal Investigator: Michael Donahue, MD, Wilmington Medical Research; Principal Investigator: Timothy Gardner, MD, East Tennessee Medical Research; Principal Investigator: Mark Lee, MD, Progressive Clinicial Research, PA; Principal Investigator: Debra Liu, MD, Piedmont Medical Research; Principal Investigator: Keith Loven, MD, Rivergate Dermatology Clinical Research Center, PLLC; Principal Investigator: Michael Maloney, MD, Cherry Creek Research, Inc.; Principal Investigator: Angela Moore, MD, Arlington Center for Dermatology; Principal Investigator: George Murakawa, MD, Dermcenter PC - Somerset Skin Centre; Principal Investigator: Catherine Pointon, MD, Metrolina Medical Research; Principal Investigator: Elyse Rafal, MD, DermResearch Center of NewYork, Inc.; Principal Investigator: Stephen Schleicher, MD, DermDox; Principal Investigator: Joel Schlessinger, MD, Skin Specialists, PC; Principal Investigator: Amanda Tauscher, MD, Compliant Clinical Research; Principal Investigator: Gary Waterman, MD, Deaconess Clinic; Principal Investigator: Jonathan Weiss, MD, Gwinnett Clinical Research Center, Inc.; Principal Investigator: Morrissa Baskin, MD, Wenatchee Valley Medical Center, Clinical Research Department; Principal Investigator: Ava Shamban, MD, The Laser Institute for Dermatology; Principal Investigator: Harry Sharata, MD, Madison Skin & Research, Inc.; Principal Investigator: Russell Mader, MD, Tricities Medical Research

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (Estimate): March 18, 2011

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: March 1, 2014

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.18142