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:
Galderma
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01355458
First received: May 16, 2011
Last updated: July 23, 2012
Last verified: July 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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).
Secondary Outcome Measures:
- 30 Minutes Effect [ Time Frame: Day 1 ] [ Designated as safety issue: No ]30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.
| 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:
- 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 greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
- 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:
- 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.
- Presence of three (3) or more facial inflammatory lesions of rosacea.
- Current treatment with monoamine oxidase (MAO) inhibitors, 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.
- 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
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 |
| Last Updated: | July 23, 2012 |
| 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 June 17, 2013