A Twelve Week Safety and Efficacy Study in Rosacea

May 1, 2015 updated by: Maruho Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Radiant Research Inc.
    • California
      • Santa Monica, California, United States, 90404
        • ATS Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • The Savin Center, PC
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research, Inc
      • Dunedin, Florida, United States, 34698
        • Dunedin Research Specialists
      • Jacksonville, Florida, United States, 32204
        • North Florida Dermatology Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group
    • Michigan
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • New York
      • Rochester, New York, United States, 14625
        • Rochester General Medical Group Center for Dermatology at Linden Oaks
      • Stoney Brook, New York, United States, 11790
        • Derm Research Center of NY Inc.
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Wake Resarch
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • Tennessee
      • Johnson City, Tennessee, United States, 37674
        • TriCities Skin and Cancer
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research, PA
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Dermatology Research Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: omiganan mid dose
omiganan mid dose once daily application for 12 weeks
Drug: omiganan
Active Comparator: omiganan high dose
omiganan high dose once daily application for 12 weeks
Drug: omiganan
Placebo Comparator: Vehicle group
Vehicle once daily application for 12 weeks
Drug: placebo
Active Comparator: omiganan low dose
omiganan low dose once daily application for 12 weeks
Drug: omiganan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in inflammatory lesion count
Time Frame: 0, 1, 3, 6, 9 and 12 weeks
0, 1, 3, 6, 9 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Success on IGA defined as clear or almost clear
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maruho Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 1, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (Estimate)

February 5, 2013

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS001-CO-PR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Papulopustular Rosacea

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe