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Phase 3 Papulopustular Rosacea Study

Information source: Galderma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Papulopustular Rosacea

Intervention: CD5024 (Drug); Azelaic acid 15% Gel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Michael Graeber, M.D., Study Director, Affiliation: Galderma R&D, LLC

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Success Rate

Absolute Change in Inflammatory Lesion Count

Secondary outcome: Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Centre de Recherche Dermatologique du Quebec Metropolitan, Quebec G1V 4X7, Canada

Total Skin and Beauty, Birmingham, Alabama 35205, United States

Coastal Clinical Research, Inc., Mobil, Alabama 36608, United States

Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States

Guildford Dermatology Specialists, Surrey, British Columbia V3R 6A7, Canada

Dermatology Specialists, Inc, Oceanside, California 92056, United States

Integrated Research Group, Inc, Riverside, California 92506, United States

Therapeutics Clinical Research, San Diego, California 92123, United States

University of California, San Francisco, San Francisco, California 94143, United States

ATS Clinical Research, Santa Monica, California 90404, United States

Redwood Dermatology Research, Santa Rosa, California 95403, United States

FXM Research Corp Miami, Miami, Florida 33175, United States

Leavitt Medical Associates of Florida dba Ameriderm Research, Ormond Beach, Florida, United States

Atlanta Dermatology, Vein & Research Center, LLC, Alpharetta, Georgia 30022, United States

Emory University, Atlanta, Georgia 30322, United States

Altman Dermatology Associates, Arlington Heights, Illinois 60005, United States

Northwestern University, Chicago, Illinois 60611, United States

Deaconess Clinic, Inc., Evansville, Indiana 47713, United States

Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana 46256, United States

Dermatology Specialists Research, Louisville, Kentucky 40202, United States

Northeast Dermatology Associates, Beverly, Massachusetts 01915, United States

David Fivenson, MD, PLC, Ann Arbor, Michigan 48103, United States

Hamzavi Dermatology, Fort Gratiot, Michigan 48059, United States

Somerset Skin Centre, Troy, Michigan 48084, United States

Dermatology Clinical Trials Unit, St. Louis, Missouri 63141, United States

Psoriasis Treatment Center of NJ, West Windsor, New Jersey, United States

Academic Dermatology Associates, Albuquerque, New Mexico 87106, United States

DermResearch Center of New York, Inc, Stony Brook, New York 11790, United States

High Point, North Carolina 27262, United States

PMG Research of Raleigh, LLC, Raleigh, North Carolina 27609, United States

Ultranova Skincare, Barrie, Ontario L4M 6L2, Canada

Dermatrials Research, Hamilton, Ontario L8N 1V6, Canada

The Guenther Dermatology Research Center, London, Ontario N6A 3H7, Canada

Lynderm Research Inc, Markham, Ontario L3P 1A8, Canada

North Bay Dermatology Centre, Inc, North Bay, Ontario P1B 3Z7, Canada

The Centre for Dermatology & Cosmetic Surgery, Richmond Hill, Ontario L4B 1A5, Canada

XLR8 Medical Research, Inc, Windsor, Ontario N8W 1E6, Canada

Oregon Dermatology and Research Center, Portland, Oregon 97210, United States

Dermatology and Skin Surgery Center, Exton, Pennsylvania 19341, United States

Philadelphia Institute of Dermatology, Fort Washington, Pennsylvania 19034, United States

Penn State Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Paddington Research, Philadelphia, Pennsylvania 19103, United States

Yardley Dermatology Associates, Yardley, Pennsylvania 19067, United States

International Dermatology Research, Inc, Montreal, Quebec H3H 1V4, Canada

The Skin Wellness Center, Knoxville, Tennessee 37922, United States

Dermatology Reserach Associates, Nashville, Tennessee 17203, United States

Arlington Research Center, Inc, Arlington, Texas 76011, United States

San Antonio, Texas 78229, United States

Stephen Miller MD, San Antonio, Texas 78229, United States

Center for Clinical Studies, Webster, Texas 77598, United States

Additional Information

Starting date: December 2011
Last updated: January 15, 2015

Page last updated: August 20, 2015

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