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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01355458
Recruitment Status : Completed
First Posted : May 18, 2011
Results First Posted : November 21, 2013
Last Update Posted : November 21, 2013
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Rosacea Drug: CD07805/47 gel Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CD07805/47 gel Drug: CD07805/47 gel
applied topically once daily
Placebo Comparator: Placebo Drug: Placebo
applied topically once daily

Primary Outcome Measures :
  1. Composite Success [ Time Frame: Day 29 ]
    Composite Success is defined as 2-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01355458

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
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, High Point NC
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.

Responsible Party: Galderma Identifier: NCT01355458     History of Changes
Other Study ID Numbers: RD.06.SPR.18140
First Posted: May 18, 2011    Key Record Dates
Results First Posted: November 21, 2013
Last Update Posted: November 21, 2013
Last Verified: September 2013

Keywords provided by Galderma:

Additional relevant MeSH terms:
Skin Diseases