A Twelve Week Safety and Efficacy Study in Rosacea
A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea
1 other identifier
interventional
240
1 country
17
Brief Summary
The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedMay 20, 2015
May 1, 2015
1 year
February 1, 2013
May 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in inflammatory lesion count
0, 1, 3, 6, 9 and 12 weeks
Secondary Outcomes (1)
Success on IGA defined as clear or almost clear
Week 12
Study Arms (4)
omiganan mid dose
ACTIVE COMPARATORomiganan mid dose once daily application for 12 weeks
omiganan high dose
ACTIVE COMPARATORomiganan high dose once daily application for 12 weeks
Vehicle group
PLACEBO COMPARATORVehicle once daily application for 12 weeks
omiganan low dose
ACTIVE COMPARATORomiganan low dose once daily application for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of papulopustular rosacea (at least 15 lesions)
You may not qualify if:
- nodular rosacea or subtype 3
- clinically significant abnormal findings that would interfere with study objectives
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maruho Co., Ltd.lead
Study Sites (17)
Radiant Research Inc.
Birmingham, Alabama, 35209, United States
ATS Clinical Research
Santa Monica, California, 90404, United States
The Savin Center, PC
New Haven, Connecticut, 06511, United States
Skin Care Research, Inc
Boca Raton, Florida, 33486, United States
Dunedin Research Specialists
Dunedin, Florida, 34698, United States
North Florida Dermatology Associates
Jacksonville, Florida, 32204, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, 46256, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
Rochester General Medical Group Center for Dermatology at Linden Oaks
Rochester, New York, 14625, United States
Derm Research Center of NY Inc.
Stoney Brook, New York, 11790, United States
Wake Resarch
Raleigh, North Carolina, 27612, United States
Oregon Dermatology and Research Center
Portland, Oregon, 97210, United States
TriCities Skin and Cancer
Johnson City, Tennessee, 37674, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Progressive Clinical Research, PA
San Antonio, Texas, 78229, United States
Dermatology Research Center
Salt Lake City, Utah, 84117, United States
Virginia Clinical Research Inc.
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2013
First Posted
February 5, 2013
Study Start
March 1, 2013
Primary Completion
March 1, 2014
Last Updated
May 20, 2015
Record last verified: 2015-05