Phase 3 Papulopustular Rosacea Study

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
• Conditions: Papulopustular Rosacea
• Intervention / Treatment: Drug: CD5024; Drug: Azelaic acid 15% Gel

• Study Type: Interventional
• Enrollment (Actual): 688
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 4X7
    • Centre De Recherche Dermatologique Du Quebec Metropolitan
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Guildford Dermatology Specialists
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Ultranova Skincare
    • Hamilton, Ontario, Canada, L8N 1V6
      • Dermatrials Research
    • London, Ontario, Canada, N6A 3H7
      • The Guenther Dermatology Research center
    • Markham, Ontario, Canada, L3P 1A8
      • Lynderm Research Inc
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre, Inc
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology & Cosmetic Surgery
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research, Inc
  • Quebec
    • Montreal, Quebec, Canada, H3H 1V4
      • International Dermatology Research, INC
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty
    • Mobile, Alabama, United States, 36608
      • Coastal Clinical Research, Inc.
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc
    • Riverside, California, United States, 92506
      • Integrated Research Group, Inc
    • San Diego, California, United States, 92123
      • Therapeutics Clinical Research
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
    • Santa Monica, California, United States, 90404
      • ATS Clinical Research
    • Santa Rosa, California, United States, 95403
      • Redwood Dermatology Research
  • Florida
    • Miami, Florida, United States, 33175
      • FXM Research Corp Miami
    • Ormond Beach, Florida, United States
      • Leavitt Medical Associates of Florida dba Ameriderm Research
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein & Research Center, LLC
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Altman Dermatology Associates
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group, LLC
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists Research
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915
      • Northeast Dermatology Associates
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD, PLC
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Dermatology Clinical Trials Unit
  • New Jersey
    • West Windsor, New Jersey, United States
      • Psoriasis Treatment Center of NJ
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • Stony Brook, New York, United States, 11790
      • DermResearch Center of New York, Inc
  • North Carolina
    • High Point, North Carolina, United States, 27262
    • Raleigh, North Carolina, United States, 27609
      • PMG Research of Raleigh, LLC
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Pennsylvania
    • Exton, Pennsylvania, United States, 19341
      • Dermatology and Skin Surgery Center
    • Fort Washington, Pennsylvania, United States, 19034
      • Philadelphia Institute of Dermatology
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Research
    • Yardley, Pennsylvania, United States, 19067
      • Yardley Dermatology Associates
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • The Skin Wellness Center
    • Nashville, Tennessee, United States, 17203
      • Dermatology Reserach Associates
  • Texas
    • Arlington, Texas, United States, 76011
      • Arlington Research Center, Inc
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78229
      • Stephen Miller MD
    • Webster, Texas, United States, 77598
      • Center For Clinical Studies

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CD5024; CD5024 1% Cream	Drug: CD5024; CD5024 1% Cream, once daily
PLACEBO_COMPARATOR: CD5024 Vehicle; CD5024 Vehicle Cream	Drug: Azelaic acid 15% Gel; Topical Gel applied twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate	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	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)	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

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): August 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 19, 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

• Keywords: PPR
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: RD.06.SPR.18171