Clinical trial NCT01494467: 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
Keywords: PPR
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2011-12-19
Enrollment: 688
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: Total Skin and Beauty
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc
state: California
city: Riverside
country: United States
facility: Integrated Research Group, Inc
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Santa Monica
country: United States
facility: ATS Clinical Research
state: California
city: Santa Rosa
country: United States
facility: Redwood Dermatology Research
state: California
city: Miami
country: United States
facility: FXM Research Corp Miami
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida dba Ameriderm Research
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Beverly
country: United States
facility: Northeast Dermatology Associates
state: Massachusetts
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Saint Louis
country: United States
facility: Dermatology Clinical Trials Unit
state: Missouri
city: West Windsor
country: United States
facility: Psoriasis Treatment Center of NJ
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Stony Brook
country: United States
facility: DermResearch Center of New York, Inc
state: New York
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Exton
country: United States
facility: Dermatology and Skin Surgery Center
state: Pennsylvania
city: Fort Washington
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Research
state: Pennsylvania
city: Yardley
country: United States
facility: Yardley Dermatology Associates
state: Pennsylvania
city: Knoxville
country: United States
facility: The Skin Wellness Center
state: Tennessee
city: Nashville
country: United States
facility: Dermatology Reserach Associates
state: Tennessee
city: Arlington
country: United States
facility: Arlington Research Center, Inc
state: Texas
city: San Antonio
country: United States
facility: Stephen Miller MD
state: Texas
city: San Antonio
country: United States
state: Texas
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Surrey
country: Canada
facility: Guildford Dermatology Specialists
state: British Columbia
city: Barrie
country: Canada
facility: Ultranova Skincare
state: Ontario
city: Hamilton
country: Canada
facility: Dermatrials Research
state: Ontario
city: London
country: Canada
facility: The Guenther Dermatology Research Center
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre, Inc
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology & Cosmetic Surgery
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research, Inc
state: Ontario
city: Montreal
country: Canada
facility: International Dermatology Research, Inc
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitan
Study officials:
affiliation: Galderma R&D, LLC
name: Michael Graeber, M.D.
role: STUDY_DIRECTOR
References: