Papulopustular Rosacea (PPR) Clinical Trial
Official title:
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.
| Verified date | January 2015 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
| Status | Completed |
| Enrollment | 683 |
| Est. completion date | August 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Stratica Medical Inc | Edmonton | Alberta |
| Canada | Eastern Canada Cutaneous Research Associates | Halifax | Nova Scotia |
| Canada | Innovaderm Research. Inc | Montreal | Quebec |
| Canada | Siena Medical | Montreal | Quebec |
| Canada | Skin Centre for Dermatology | Peterborough | Ontario |
| Canada | Nexus Clinical Research | St John's | Newfoundland and Labrador |
| Canada | Toronto Research Centre, Inc. | Toronto | Ontario |
| Canada | Derm Research@888 Inc. | Vancouver | British Columbia |
| Canada | Windsor Clinical Research, Inc. | Windsor | Ontario |
| Canada | Dermadvances Research | Winnepeg | Manitoba |
| United States | DermResearch, Inc. | Austin | Texas |
| United States | The Center for Clinical & Cosmetic Research | Aventura | Florida |
| United States | UAB Dermatology Clinical Research | Birmingham | Alabama |
| United States | The Dermatology and Aesthetic Center | Boca Raton | Florida |
| United States | Laser & Skin Surgery Center of Indiana | Carmel | Indiana |
| United States | PMG Research of Charlotte | Charlotte | North Carolina |
| United States | Dermatology Research Center of Cincinnati | Cincinnati | Ohio |
| United States | Modern Research Associates | Dallas | Texas |
| United States | Cherry Creek Research, Inc. | Denver | Colorado |
| United States | Henry Ford Health Systems Department of Dermatology | Detroit | Michigan |
| United States | Anderson & Collins Clinical Research, | Edison | New Jersey |
| United States | Center for Clinical Studies | Houston | Texas |
| United States | North Florida Dermatology Associates | Jacksonville | Florida |
| United States | TriCities Skin and Cancer | Johnson City | Tennessee |
| United States | Dermatology Associates of Kingsport, PC | Kingsport | Tennessee |
| United States | Baker Allergy, Asthma and Dermatology Research Center | Lake Oswego | Oregon |
| United States | Dermatology Research Associates | Los Angeles | California |
| United States | Derm Research, PLLC | Louisville | Kentucky |
| United States | The Education & Research Foundation, Inc. | Lynchburg | Virginia |
| United States | FXM Research Miramar | Miramar | Florida |
| United States | PMG Research of Charleston | Mount Pleasant | South Carolina |
| United States | MedaPhase, Inc. | Newnan | Georgia |
| United States | Central Sooner Research | Norman | Oklahoma |
| United States | Skin Specialists, PC | Omaha | Nebraska |
| United States | The Indiana Clinical Trials Center | Plainfield | Indiana |
| United States | Wake Research Associates | Raleigh | North Carolina |
| United States | Lawrence Green, MD, LLC | Rockville | Maryland |
| United States | Northwest AR Clinical Trials Center | Rogers | Arkansas |
| United States | Central Dermatology PC | Saint Louis | Missouri |
| United States | Dermatology Research Center, Inc. | Salt Lake City | Utah |
| United States | Progressive Clinical Research | San Antonio | Texas |
| United States | University Clinical Trials | San Diego | California |
| United States | Research Across America | Santa Ana | California |
| United States | PLLC dba Dermatology Associates | Seattle | Washington |
| United States | The Polyclinic | Seattle | Washington |
| United States | Palmetto Clinical Trial Services, LLC | Simpsonville | South Carolina |
| United States | The South Bend Clinic, LLP | South Bend | Indiana |
| United States | Haber Dermatology Clinical Research Center | South Euclid | Ohio |
| United States | Grekin Skin Institute | Warren | Michigan |
| United States | Department of Dermatology - Wake Forest University Health Sciences | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success Rate | Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) 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) |
Week 12 | |
| Primary | Absolute Change in Inflammatory Lesion Count | Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). | Baseline to Week 12 | |
| Secondary | Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) | Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). | Baseline to Week 12 |