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Phase 3 Papulopustular Rosacea Study

Primary Purpose

Papulopustular Rosacea

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
CD5024
Azelaic acid 15% Gel
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papulopustular Rosacea focused on measuring PPR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Total Skin and Beauty
  • Coastal Clinical Research, Inc.
  • Burke Pharmaceutical Research
  • Dermatology Specialists, Inc
  • Integrated Research Group, Inc
  • Therapeutics Clinical Research
  • University of California, San Francisco
  • ATS Clinical Research
  • Redwood Dermatology Research
  • FXM Research Corp Miami
  • Leavitt Medical Associates of Florida dba Ameriderm Research
  • Atlanta Dermatology, Vein & Research Center, LLC
  • Emory University
  • Altman Dermatology Associates
  • Northwestern University
  • Deaconess Clinic, Inc.
  • Dawes Fretzin Clinical Research Group, LLC
  • Dermatology Specialists Research
  • Northeast Dermatology Associates
  • David Fivenson, MD, PLC
  • Hamzavi Dermatology
  • Somerset Skin Centre
  • Dermatology Clinical Trials Unit
  • Psoriasis Treatment Center of NJ
  • Academic Dermatology Associates
  • DermResearch Center of New York, Inc
  • PMG Research of Raleigh, LLC
  • Oregon Dermatology and Research Center
  • Dermatology and Skin Surgery Center
  • Philadelphia Institute of Dermatology
  • Penn State Hershey Medical Center
  • Paddington Research
  • Yardley Dermatology Associates
  • The Skin Wellness Center
  • Dermatology Reserach Associates
  • Arlington Research Center, Inc
  • Stephen Miller MD
  • Center for Clinical Studies
  • Guildford Dermatology Specialists
  • Ultranova Skincare
  • Dermatrials Research
  • The Guenther Dermatology Research Center
  • Lynderm Research Inc
  • North Bay Dermatology Centre, Inc
  • The Centre for Dermatology & Cosmetic Surgery
  • XLR8 Medical Research, Inc
  • International Dermatology Research, Inc
  • Centre de Recherche Dermatologique du Quebec Metropolitan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CD5024

CD5024 Vehicle

Arm Description

CD5024 1% Cream

CD5024 Vehicle Cream

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

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).

Full Information

First Posted
December 14, 2011
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01494467
Brief Title
Phase 3 Papulopustular Rosacea Study
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 Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
PPR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
688 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD5024
Arm Type
Experimental
Arm Description
CD5024 1% Cream
Arm Title
CD5024 Vehicle
Arm Type
Placebo Comparator
Arm Description
CD5024 Vehicle Cream
Intervention Type
Drug
Intervention Name(s)
CD5024
Intervention Description
CD5024 1% Cream, once daily
Intervention Type
Drug
Intervention Name(s)
Azelaic acid 15% Gel
Intervention Description
Topical Gel applied twice daily
Primary Outcome Measure Information:
Title
Success Rate
Description
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)
Time Frame
Week 12
Title
Absolute Change in Inflammatory Lesion Count
Description
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).
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Description
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).
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe), The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face. Exclusion Criteria: 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, The subject has rosacea with more than two nodules on the face.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, M.D.
Organizational Affiliation
Galderma R&D, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Total Skin and Beauty
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Burke Pharmaceutical Research
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Dermatology Specialists, Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Integrated Research Group, Inc
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
ATS Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Redwood Dermatology Research
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
FXM Research Corp Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Leavitt Medical Associates of Florida dba Ameriderm Research
City
Ormond Beach
State/Province
Florida
Country
United States
Facility Name
Atlanta Dermatology, Vein & Research Center, LLC
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Altman Dermatology Associates
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Deaconess Clinic, Inc.
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Dermatology Specialists Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Northeast Dermatology Associates
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
David Fivenson, MD, PLC
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Somerset Skin Centre
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Dermatology Clinical Trials Unit
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Psoriasis Treatment Center of NJ
City
West Windsor
State/Province
New Jersey
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
DermResearch Center of New York, Inc
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Dermatology and Skin Surgery Center
City
Exton
State/Province
Pennsylvania
ZIP/Postal Code
19341
Country
United States
Facility Name
Philadelphia Institute of Dermatology
City
Fort Washington
State/Province
Pennsylvania
ZIP/Postal Code
19034
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Paddington Research
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Yardley Dermatology Associates
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
The Skin Wellness Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Dermatology Reserach Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
17203
Country
United States
Facility Name
Arlington Research Center, Inc
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
Stephen Miller MD
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Guildford Dermatology Specialists
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Ultranova Skincare
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6L2
Country
Canada
Facility Name
Dermatrials Research
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1V6
Country
Canada
Facility Name
The Guenther Dermatology Research Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 3H7
Country
Canada
Facility Name
Lynderm Research Inc
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1A8
Country
Canada
Facility Name
North Bay Dermatology Centre, Inc
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 3Z7
Country
Canada
Facility Name
The Centre for Dermatology & Cosmetic Surgery
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4B 1A5
Country
Canada
Facility Name
XLR8 Medical Research, Inc
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
International Dermatology Research, Inc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Centre de Recherche Dermatologique du Quebec Metropolitan
City
Quebec
ZIP/Postal Code
G1V 4X7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Phase 3 Papulopustular Rosacea Study

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