Clinical trial NCT01493687: Phase 3 Papulopustular Rosacea Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Papulopustular Rosacea (PPR)
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-12-16
Enrollment: 683
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Success Rate
timeFrame: Week 12
measure: Absolute Change in Inflammatory Lesion Count
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Dermatology Clinical Research
state: Alabama
city: Rogers
country: United States
facility: Northwest AR Clinical Trials Center
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: San Diego
country: United States
facility: University Clinical Trials
state: California
city: Santa Ana
country: United States
facility: Research Across America
state: California
city: Denver
country: United States
facility: Cherry Creek Research, Inc.
state: Colorado
city: Aventura
country: United States
facility: The Center for Clinical & Cosmetic Research
state: Florida
city: Boca Raton
country: United States
facility: The Dermatology and Aesthetic Center
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates
state: Florida
city: Miramar
country: United States
facility: FXM Research Miramar
state: Florida
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic, LLP
state: Indiana
city: Louisville
country: United States
facility: Derm Research, PLLC
state: Kentucky
city: Rockville
country: United States
facility: Lawrence Green, MD, LLC
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health Systems Department of Dermatology
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Saint Louis
country: United States
facility: Central Dermatology PC
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Edison
country: United States
facility: Anderson & Collins Clinical Research,
state: New Jersey
city: Charlotte
country: United States
facility: PMG Research of Charlotte
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Department of Dermatology - Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: Dermatology Research Center of Cincinnati
state: Ohio
city: South Euclid
country: United States
facility: Haber Dermatology Clinical Research Center
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Lake Oswego
country: United States
facility: Baker Allergy, Asthma and Dermatology Research Center
state: Oregon
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston
state: South Carolina
city: Simpsonville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Johnson City
country: United States
facility: TriCities Skin and Cancer
state: Tennessee
city: Kingsport
country: United States
facility: Dermatology Associates of Kingsport, PC
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Seattle
country: United States
facility: PLLC dba Dermatology Associates
state: Washington
city: Seattle
country: United States
facility: The Polyclinic
state: Washington
city: Edmonton
country: Canada
facility: Stratica Medical Inc
state: Alberta
city: Vancouver
country: Canada
facility: Derm Research@888 Inc.
state: British Columbia
city: Winnepeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: St John's
country: Canada
facility: Nexus Clinical Research
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Eastern Canada Cutaneous Research Associates
state: Nova Scotia
city: Peterborough
country: Canada
facility: Skin Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre, Inc.
state: Ontario
city: Windsor
country: Canada
facility: Windsor Clinical Research, Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research. Inc
state: Quebec
city: Montreal
country: Canada
facility: Siena Medical
state: Quebec
Study officials:
affiliation: Galderma R&D, LLC
name: Michael Graeber, M.D.
role: STUDY_DIRECTOR
References: