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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01355458
First received: May 16, 2011
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Rosacea
Drug: CD07805/47 gel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Galderma:

Primary Outcome Measures:
  • Composite Success [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
    Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).


Enrollment: 260
Study Start Date: May 2011
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD07805/47 gel Drug: CD07805/47 gel
applied topically once daily
Placebo Comparator: Placebo Drug: Placebo
applied topically once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355458

Locations
United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Michigan
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States, 48038
United States, New Jersey
Windsor Dermatology
East Windsor, New Jersey, United States, 08520
United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Pennsylvania
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States, 19034
United States, Tennessee
The Skin Wellness Center
Knoxville, Tennessee, United States, 37922
United States, Texas
Arlington Center for Dermatology
Arlington, Texas, United States, 76011
DermResearch, Inc.
Austin, Texas, United States, 78759
Dermatology Treatment & Research Center
Dallas, Texas, United States, 72230
United States, Virginia
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501
Canada, Ontario
Lynderm Research Inc
Markham, Ontario, Canada, L3P 1A8
Windsor Clinical Research Inc.
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Innovaderm Research, Inc
Montreal, Quebec, Canada, H2K 4L5
Sponsors and Collaborators
Galderma
Investigators
Study Chair: Michael Graeber, MD Galderma
Principal Investigator: William Abramovits, MD Dermatology Treatment & Research Center
Principal Investigator: Robert Bissonette, MD Innovaderm Research Inc.
Principal Investigator: Zoe Draelos, MD Dermatology Consulting Services
Principal Investigator: Kimberly Grande, MD The Skin Wellness Center
Principal Investigator: Michael Jarratt, MD DermResearch, Inc.
Principal Investigator: Charles Lynde, MD Lynderm Research Inc
Principal Investigator: Robert Matheson, MD Oregon Medical Research Center
Principal Investigator: Kappa Meadows, MD The Education & Research Foundation, Inc.
Principal Investigator: Angela Moore, MD Arlington Center for Dermatology
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.
  More Information

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01355458     History of Changes
Other Study ID Numbers: RD.06.SPR.18140
Study First Received: May 16, 2011
Results First Received: September 19, 2013
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
rosacea

Additional relevant MeSH terms:
Rosacea
Erythema
Skin Diseases

ClinicalTrials.gov processed this record on July 24, 2014