Phase 3 Papulopustular Rosacea Study

Papulopustular Rosacea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494467
• Other study ID #: RD.06.SPR.18171
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: January 2015
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 688
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• CD5024
CD5024 1% Cream, once daily
• Azelaic acid 15% Gel
Topical Gel applied twice daily

Locations

Country	Name	City	State
Canada	Ultranova Skincare	Barrie	Ontario
Canada	Dermatrials Research	Hamilton	Ontario
Canada	The Guenther Dermatology Research Center	London	Ontario
Canada	Lynderm Research Inc	Markham	Ontario
Canada	International Dermatology Research, Inc	Montreal	Quebec
Canada	North Bay Dermatology Centre, Inc	North Bay	Ontario
Canada	Centre de Recherche Dermatologique du Quebec Metropolitan	Quebec
Canada	The Centre for Dermatology & Cosmetic Surgery	Richmond Hill	Ontario
Canada	Guildford Dermatology Specialists	Surrey	British Columbia
Canada	XLR8 Medical Research, Inc	Windsor	Ontario
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	Atlanta Dermatology, Vein & Research Center, LLC	Alpharetta	Georgia
United States	David Fivenson, MD, PLC	Ann Arbor	Michigan
United States	Arlington Research Center, Inc	Arlington	Texas
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	Emory University	Atlanta	Georgia
United States	Northeast Dermatology Associates	Beverly	Massachusetts
United States	Total Skin and Beauty	Birmingham	Alabama
United States	Northwestern University	Chicago	Illinois
United States	Deaconess Clinic, Inc.	Evansville	Indiana
United States	Dermatology and Skin Surgery Center	Exton	Pennsylvania
United States	Hamzavi Dermatology	Fort Gratiot	Michigan
United States	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	Dermatology Specialists Research	Louisville	Kentucky
United States	FXM Research Corp Miami	Miami	Florida
United States	Coastal Clinical Research, Inc.	Mobile	Alabama
United States	Dermatology Reserach Associates	Nashville	Tennessee
United States	Dermatology Specialists, Inc	Oceanside	California
United States	Leavitt Medical Associates of Florida dba Ameriderm Research	Ormond Beach	Florida
United States	Paddington Research	Philadelphia	Pennsylvania
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	Integrated Research Group, Inc	Riverside	California
United States	Dermatology Clinical Trials Unit	Saint Louis	Missouri
United States	Stephen Miller MD	San Antonio	Texas
United States	Therapeutics Clinical Research	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	ATS Clinical Research	Santa Monica	California
United States	Redwood Dermatology Research	Santa Rosa	California
United States	DermResearch Center of New York, Inc	Stony Brook	New York
United States	Somerset Skin Centre	Troy	Michigan
United States	Center for Clinical Studies	Webster	Texas
United States	Psoriasis Treatment Center of NJ	West Windsor	New Jersey
United States	Yardley Dermatology Associates	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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