Phase 3 Papulopustular Rosacea Study

NCT ID: NCT01493687

Last Updated: 2021-02-18

Study Results

Results available

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

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

683 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-08-31

Brief Summary

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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

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Conditions

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Papulopustular Rosacea (PPR)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

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CD5024

CD5024 1% Cream, once daily

Intervention Type DRUG

Azelaic acid 15% Gel

Topical Gel applied twice daily

Intervention Type DRUG

Eligibility Criteria

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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

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Graeber, M.D.

Role: STUDY_DIRECTOR

Galderma R&D, LLC

Locations

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UAB Dermatology Clinical Research

Birmingham, Alabama, United States

Site Status

Northwest AR Clinical Trials Center

Rogers, Arkansas, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

University Clinical Trials

San Diego, California, United States

Site Status

Research Across America

Santa Ana, California, United States

Site Status

Cherry Creek Research, Inc.

Denver, Colorado, United States

Site Status

The Center for Clinical & Cosmetic Research

Aventura, Florida, United States

Site Status

The Dermatology and Aesthetic Center

Boca Raton, Florida, United States

Site Status

North Florida Dermatology Associates

Jacksonville, Florida, United States

Site Status

FXM Research Miramar

Miramar, Florida, United States

Site Status

MedaPhase, Inc.

Newnan, Georgia, United States

Site Status

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, United States

Site Status

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Site Status

The South Bend Clinic, LLP

South Bend, Indiana, United States

Site Status

Derm Research, PLLC

Louisville, Kentucky, United States

Site Status

Lawrence Green, MD, LLC

Rockville, Maryland, United States

Site Status

Henry Ford Health Systems Department of Dermatology

Detroit, Michigan, United States

Site Status

Grekin Skin Institute

Warren, Michigan, United States

Site Status

Central Dermatology PC

St Louis, Missouri, United States

Site Status

Skin Specialists, PC

Omaha, Nebraska, United States

Site Status

Anderson & Collins Clinical Research,

Edison, New Jersey, United States

Site Status

PMG Research of Charlotte

Charlotte, North Carolina, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

Department of Dermatology - Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Dermatology Research Center of Cincinnati

Cincinnati, Ohio, United States

Site Status

Haber Dermatology Clinical Research Center

South Euclid, Ohio, United States

Site Status

Central Sooner Research

Norman, Oklahoma, United States

Site Status

Baker Allergy, Asthma and Dermatology Research Center

Lake Oswego, Oregon, United States

Site Status

PMG Research of Charleston

Mt. Pleasant, South Carolina, United States

Site Status

Palmetto Clinical Trial Services, LLC

Simpsonville, South Carolina, United States

Site Status

TriCities Skin and Cancer

Johnson City, Tennessee, United States

Site Status

Dermatology Associates of Kingsport, PC

Kingsport, Tennessee, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

Modern Research Associates

Dallas, Texas, United States

Site Status

Center for Clinical Studies

Houston, Texas, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

Dermatology Research Center, Inc.

Salt Lake City, Utah, United States

Site Status

The Education & Research Foundation, Inc.

Lynchburg, Virginia, United States

Site Status

PLLC dba Dermatology Associates

Seattle, Washington, United States

Site Status

The Polyclinic

Seattle, Washington, United States

Site Status

Stratica Medical Inc

Edmonton, Alberta, Canada

Site Status

Derm Research@888 Inc.

Vancouver, British Columbia, Canada

Site Status

Dermadvances Research

Winnepeg, Manitoba, Canada

Site Status

Nexus Clinical Research

St. John's, Newfoundland and Labrador, Canada

Site Status

Eastern Canada Cutaneous Research Associates

Halifax, Nova Scotia, Canada

Site Status

Skin Centre for Dermatology

Peterborough, Ontario, Canada

Site Status

Toronto Research Centre, Inc.

Toronto, Ontario, Canada

Site Status

Windsor Clinical Research, Inc.

Windsor, Ontario, Canada

Site Status

Innovaderm Research. Inc

Montreal, Quebec, Canada

Site Status

Siena Medical

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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RD.06.SPR.18170

Identifier Type: -

Identifier Source: org_study_id

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