A Twelve Week Safety and Efficacy Study in Rosacea

Phase 2

Completed

• Conditions: Papulopustular Rosacea
• Interventions: Drug: omiganan; Drug: placebo

• Registration Number: NCT01784133
• Lead Sponsor: Maruho Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-01
• Study First Submitted QC: 2013-02-04
• Study First Posted: 2013-02-05
• Study Start: 2013-03
• Primary Completion: 2014-03
• Status Verified: 2015-05
• Disposition First Submitted: 2015-05-01
• Disposition First Submitted QC: 2015-05-01
• Last Update Submitted: 2015-05-01
• Disposition First Posted: 2015-05-20
• Last Update Posted: 2015-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• diagnosis of papulopustular rosacea (at least 15 lesions)

Exclusion Criteria

• nodular rosacea or subtype 3
• clinically significant abnormal findings that would interfere with study objectives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
omiganan mid dose	omiganan	omiganan mid dose once daily application for 12 weeks
omiganan high dose	omiganan	omiganan high dose once daily application for 12 weeks
Vehicle group	placebo	Vehicle once daily application for 12 weeks
omiganan low dose	omiganan	omiganan low dose once daily application for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in inflammatory lesion count	0, 1, 3, 6, 9 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Success on IGA defined as clear or almost clear	Week 12

Trial Locations

Locations (17)

TriCities Skin and Cancer; 🇺🇸 Johnson City, Tennessee, United States

ATS Clinical Research; 🇺🇸 Santa Monica, California, United States

Wake Resarch; 🇺🇸 Raleigh, North Carolina, United States

Derm Research Center of NY Inc.; 🇺🇸 Stoney Brook, New York, United States

Virginia Clinical Research Inc.; 🇺🇸 Norfolk, Virginia, United States

Dunedin Research Specialists; 🇺🇸 Dunedin, Florida, United States

Skin Care Research, Inc; 🇺🇸 Boca Raton, Florida, United States

Grekin Skin Institute; 🇺🇸 Warren, Michigan, United States

North Florida Dermatology Associates; 🇺🇸 Jacksonville, Florida, United States

Rochester General Medical Group Center for Dermatology at Linden Oaks; 🇺🇸 Rochester, New York, United States

Dawes Fretzin Clinical Research Group; 🇺🇸 Indianapolis, Indiana, United States

Radiant Research Inc.; 🇺🇸 Birmingham, Alabama, United States

The Savin Center, PC; 🇺🇸 New Haven, Connecticut, United States

Oregon Dermatology and Research Center; 🇺🇸 Portland, Oregon, United States

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States

Progressive Clinical Research, PA; 🇺🇸 San Antonio, Texas, United States

Dermatology Research Center; 🇺🇸 Salt Lake City, Utah, United States