Phase 3 Papulopustular Rosacea Study

February 16, 2021 updated by: Galderma R&D

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.

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

683

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alberta
      • Edmonton, Alberta, Canada, T5K 1X3
        • Stratica Medical Inc
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3Y1
        • Derm Research@888 Inc.
    • Manitoba
      • Winnepeg, Manitoba, Canada, R3C 1R4
        • Dermadvances Research
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Nexus Clinical Research
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1Z4
        • Eastern Canada Cutaneous Research Associates
    • Ontario
      • Peterborough, Ontario, Canada, K9J 1Z2
        • SKiN Centre for Dermatology
      • Toronto, Ontario, Canada, M3H 5Y8
        • Toronto Research Centre, Inc.
      • Windsor, Ontario, Canada, N8W 5L7
        • Windsor Clinical Research, Inc.
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research. Inc
      • Montreal, Quebec, Canada, H3Z 2S6
        • Siena Medical
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Dermatology Clinical Research
    • Arkansas
      • Rogers, Arkansas, United States, 72758
        • Northwest AR Clinical Trials Center
    • California
      • Los Angeles, California, United States, 30127
        • Dermatology Research Associates
      • San Diego, California, United States, 92123
        • University Clinical Trials
      • Santa Ana, California, United States, 92705
        • Research Across America
    • Colorado
      • Denver, Colorado, United States, 80209
        • Cherry Creek Research, Inc.
    • Florida
      • Aventura, Florida, United States, 33180
        • The Center for Clinical & Cosmetic Research
      • Boca Raton, Florida, United States, 33486
        • The Dermatology and Aesthetic Center
      • Jacksonville, Florida, United States, 32204
        • North Florida Dermatology Associates
      • Miramar, Florida, United States, 33027
        • FXM Research Miramar
    • Georgia
      • Newnan, Georgia, United States, 30263
        • MedaPhase, Inc.
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Laser & Skin Surgery Center of Indiana
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
      • South Bend, Indiana, United States, 46617
        • The South Bend Clinic, LLP
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Derm Research, PLLC
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence Green, MD, LLC
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems Department of Dermatology
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Central Dermatology PC
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC
    • New Jersey
      • Edison, New Jersey, United States, 08817
        • Anderson & Collins Clinical Research,
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • PMG Research of Charlotte
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Department of Dermatology - Wake Forest University Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Dermatology Research Center of Cincinnati
      • South Euclid, Ohio, United States, 44118
        • Haber Dermatology Clinical Research Center
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
    • Oregon
      • Lake Oswego, Oregon, United States, 97035
        • Baker Allergy, Asthma and Dermatology Research Center
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • PMG Research of Charleston
      • Simpsonville, South Carolina, United States, 29681
        • Palmetto Clinical Trial Services, LLC
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • TriCities Skin and Cancer
      • Kingsport, Tennessee, United States, 37660
        • Dermatology Associates of Kingsport, PC
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • Dallas, Texas, United States, 75231
        • Modern Research Associates
      • Houston, Texas, United States, 77030
        • Center for Clinical Studies
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Dermatology Research Center, Inc.
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Education & Research Foundation, Inc.
    • Washington
      • Seattle, Washington, United States, 98122
        • The Polyclinic
      • Seattle, Washington, United States, 98101
        • PLLC dba Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CD5024
CD5024 1% Cream
CD5024 1% Cream, once daily
Placebo Comparator: CD5024 Vehicle
CD5024 Vehicle Cream
Topical Gel applied twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate
Time Frame: Week 12

Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.

Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:

Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)

Week 12
Absolute Change in Inflammatory Lesion Count
Time Frame: Baseline to Week 12
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Time Frame: Baseline to Week 12
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 15, 2011

First Posted (Estimate)

December 16, 2011

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

January 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • RD.06.SPR.18170

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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