A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.
18 Years
N/A
Both
Papulopustular Rosacea (PPR)
Trial Information
A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.
Inclusion Criteria:
1. The subject has papulopustular rosacea with an Investigator Global Assessment (IGA)
score rated 3 (moderate) or 4 (severe),
2. The subject has at least 15 but not more than 70 inflammatory lesions (papules and
pustules) on the face.
Exclusion Criteria:
1. The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans,
isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that
may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial
keratosis pilaris, seborrheic dermatitis, and acne,
2. The subject has rosacea with more than two nodules on the face.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Success Rate
Outcome Description:
The percentage of stubjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 based on the Investigator Global Assessment (IGA) Score. Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale. Clear= 0 No inflammatory lesions present, no erythema Almost Clear= 1 Very few small papules/pustules, very mild erythema present Mild 2= Few small papules/pustules, mild erythema Moderate 3= Several small or large papules/pustules, moderate erythema Severe 4= Numerous small and/or large papules/pustules, severe erythema
Outcome Time Frame:
Baseline to Week 12
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
RD.06.SPR.18170
NCT ID:
NCT01493687
Start Date:
December 2011
Completion Date:
August 2013
Related Keywords:
- Papulopustular Rosacea (PPR)
- Rosacea
Name | Location |
|---|---|
| The Polyclinic | Seattle, Washington 98122 |
| Cherry Creek Research, Inc. | Denver, Colorado 80246 |
| Center For Clinical Studies | Houston, Texas 77030 |
| The Dermatology and Aesthetic Center | Boca Raton, Florida 33486 |
| Derm Research, PLLC | Louisville, Kentucky 40217 |
| Dermatology Associates of Kingsport, PC | Kingsport, Tennessee 37660 |
| Wake Research Associates | Raleigh, North Carolina 27612 |
| DermResearch, Inc. | Austin, Texas 78759 |
| Dermatology Research Associates | Los Angeles, California 90045 |
| Grekin Skin Institute | Warren, Michigan 48093 |
| Progressive Clinical Research | San Antonio, Texas 78229 |
| North Florida Dermatology Associates | Jacksonville, Florida |
| Skin Specialists, PC | Omaha, Nebraska |
| Palmetto Clinical Trial Services, LLC | Simpsonville, South Carolina |
| MedaPhase, Inc. | Newman, Georgia 30263 |
| Dermatology Research Center, Inc. | Salt Lake City, Utah 84124 |
| The South Bend Clinic, LLP | South Bend, Indiana 46617 |
| Modern Research Associates | Dallas, Texas 75231 |
| PMG Research of Charlotte | Charlotte, North Carolina 28209 |
| Central Sooner Research | Norman, Oklahoma 73071 |
| Dermatology Research Center of Cincinnati | Cincinnati, Ohio 45220 |
| UAB Dermatology Clinical Research | Birmingham, Alabama 35233 |
| Northwest AR Clinical Trials Center | Rogers, Arkansas 72758 |
| University Clinical Trials | San Diego, California 92123 |
| Research Across America | Santa Ana, California 92705 |
| The Center for Clinical & Cosmetic Research | Aventura, Florida 33180 |
| FXM Research Miramar | Miramar, Florida 33027 |
| Laser & Skin Surgery Center of Indiana | Carmel, Indiana 46032 |
| The Indiana Clinical Trials Center | Plainfield, Indiana 46168 |
| Lawrence Green, MD, LLC | Rockville, Maryland 20850 |
| Henry Ford Health Systems Department of Dermatology | Detroit, Michigan 48202 |
| Central Dermatology PC | St. Louis, Missouri 63117 |
| Anderson & Collins Clinical Research, | Edison, New Jersey 08817 |
| Department of Dermatology - Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |
| Haber Dermatology Clinical Research Center | South Euclid, Ohio 44118 |
| Baker Allergy, Asthma and Dermatology Research Center | Lake Oswego, Oregon 97035 |
| PMG Research of Charleston | Mt. Pleasant, South Carolina 29464 |
| TriCities Skin and Cancer | Johnson City, Tennessee 37604 |
| The Education & Research Foundation, Inc. | Lynchburg, Virginia 24501 |
| PLLC dba Dermatology Associates | Seattle, Washington 98101 |
