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:
NCT01355471
First received: May 16, 2011
Last updated: July 23, 2012
Last verified: July 2012
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Purpose
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.
| 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: | 293 |
| Study Start Date: | May 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | November 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: NCT01355471
Locations
| United States, Arkansas | |
| Burke Pharmaceutical Research | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, Florida | |
| Baumann Cosmetic and Research Institute | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Georgia | |
| MedaPhase, Inc. | |
| Newnan, Georgia, United States, 30263 | |
| United States, Kentucky | |
| Dermatology Specialists Research | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Michigan | |
| Grekin Skin Institute | |
| Warren, Michigan, United States, 48088 | |
| United States, Missouri | |
| Central Dermatology PC | |
| St. Louis, Missouri, United States, 63117 | |
| United States, New York | |
| Skin Specialty Dermatology | |
| New York, New York, United States, 10155 | |
| United States, Ohio | |
| Haber Dermatology & Cosmetic Surgery | |
| South Euclid, Ohio, United States, 44118 | |
| United States, Oregon | |
| Oregon Dermatology and Research Center | |
| Portland, Oregon, United States, 97210 | |
| United States, South Carolina | |
| Palmetto Clinical Trial Services, LLC | |
| Greenville, South Carolina, United States, 29607 | |
| United States, Texas | |
| J&S Studies Inc. | |
| College Station, Texas, United States, 77845 | |
| United States, Washington | |
| Premier Clinical Research | |
| Spokane, Washington, United States, 99201 | |
| Canada, Alberta | |
| Kirk Barber Research Inc. | |
| Calgary, Alberta, Canada, T25 3B3 | |
| Canada, Newfoundland and Labrador | |
| Nexus Clinical Research | |
| St John's, Newfoundland and Labrador, Canada, A1A 5E8 | |
| Newlab Clinical Research Inc. | |
| St. John's, Newfoundland and Labrador, Canada, A1C2H5 | |
Sponsors and Collaborators
Galderma
Investigators
| Study Chair: | Michael Graeber, MD | Galderma |
| 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: | Joseph Fowler, MD | Dermatology Specialists PSC |
| 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: | Terry Jones, MD | J&S Studies Inc. |
| 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 |
More Information
No publications provided
| Responsible Party: | Galderma |
| ClinicalTrials.gov Identifier: | NCT01355471 History of Changes |
| Other Study ID Numbers: | RD.06.SPR.18141 |
| 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 May 19, 2013