Phase 3 Papulopustular Rosacea Study

NCT ID: NCT01494467

Last Updated: 2021-02-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

688 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Papulopustular Rosacea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CD5024

CD5024 1% Cream

Group Type EXPERIMENTAL

CD5024

Intervention Type DRUG

CD5024 1% Cream, once daily

CD5024 Vehicle

CD5024 Vehicle Cream

Group Type PLACEBO_COMPARATOR

Azelaic acid 15% Gel

Intervention Type DRUG

Topical Gel applied twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CD5024

CD5024 1% Cream, once daily

Intervention Type DRUG

Azelaic acid 15% Gel

Topical Gel applied twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Graeber, M.D.

Role: STUDY_DIRECTOR

Galderma R&D, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Total Skin and Beauty

Birmingham, Alabama, United States

Site Status

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Site Status

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Site Status

Dermatology Specialists, Inc

Oceanside, California, United States

Site Status

Integrated Research Group, Inc

Riverside, California, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

ATS Clinical Research

Santa Monica, California, United States

Site Status

Redwood Dermatology Research

Santa Rosa, California, United States

Site Status

FXM Research Corp Miami

Miami, Florida, United States

Site Status

Leavitt Medical Associates of Florida dba Ameriderm Research

Ormond Beach, Florida, United States

Site Status

Atlanta Dermatology, Vein & Research Center, LLC

Alpharetta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Altman Dermatology Associates

Arlington Heights, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Deaconess Clinic, Inc.

Evansville, Indiana, United States

Site Status

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

Site Status

Dermatology Specialists Research

Louisville, Kentucky, United States

Site Status

Northeast Dermatology Associates

Beverly, Massachusetts, United States

Site Status

David Fivenson, MD, PLC

Ann Arbor, Michigan, United States

Site Status

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Site Status

Somerset Skin Centre

Troy, Michigan, United States

Site Status

Dermatology Clinical Trials Unit

St Louis, Missouri, United States

Site Status

Psoriasis Treatment Center of NJ

West Windsor, New Jersey, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

DermResearch Center of New York, Inc

Stony Brook, New York, United States

Site Status

High Point, North Carolina, United States

Site Status

PMG Research of Raleigh, LLC

Raleigh, North Carolina, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

Dermatology and Skin Surgery Center

Exton, Pennsylvania, United States

Site Status

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, United States

Site Status

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Paddington Research

Philadelphia, Pennsylvania, United States

Site Status

Yardley Dermatology Associates

Yardley, Pennsylvania, United States

Site Status

The Skin Wellness Center

Knoxville, Tennessee, United States

Site Status

Dermatology Reserach Associates

Nashville, Tennessee, United States

Site Status

Arlington Research Center, Inc

Arlington, Texas, United States

Site Status

Stephen Miller MD

San Antonio, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Center for Clinical Studies

Webster, Texas, United States

Site Status

Guildford Dermatology Specialists

Surrey, British Columbia, Canada

Site Status

Ultranova Skincare

Barrie, Ontario, Canada

Site Status

Dermatrials Research

Hamilton, Ontario, Canada

Site Status

The Guenther Dermatology Research Center

London, Ontario, Canada

Site Status

Lynderm Research Inc

Markham, Ontario, Canada

Site Status

North Bay Dermatology Centre, Inc

North Bay, Ontario, Canada

Site Status

The Centre for Dermatology & Cosmetic Surgery

Richmond Hill, Ontario, Canada

Site Status

XLR8 Medical Research, Inc

Windsor, Ontario, Canada

Site Status

International Dermatology Research, Inc

Montreal, Quebec, Canada

Site Status

Centre de Recherche Dermatologique du Quebec Metropolitan

Québec, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RD.06.SPR.18171

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.