A Twelve Week Safety and Efficacy Study in Rosacea

NCT ID: NCT01784133

Last Updated: 2015-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Brief Summary

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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

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Conditions

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Papulopustular Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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omiganan mid dose

omiganan mid dose once daily application for 12 weeks

Group Type ACTIVE_COMPARATOR

omiganan

Intervention Type DRUG

omiganan high dose

omiganan high dose once daily application for 12 weeks

Group Type ACTIVE_COMPARATOR

omiganan

Intervention Type DRUG

Vehicle group

Vehicle once daily application for 12 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

omiganan low dose

omiganan low dose once daily application for 12 weeks

Group Type ACTIVE_COMPARATOR

omiganan

Intervention Type DRUG

Interventions

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omiganan

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maruho Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Radiant Research Inc.

Birmingham, Alabama, United States

Site Status

ATS Clinical Research

Santa Monica, California, United States

Site Status

The Savin Center, PC

New Haven, Connecticut, United States

Site Status

Skin Care Research, Inc

Boca Raton, Florida, United States

Site Status

Dunedin Research Specialists

Dunedin, Florida, United States

Site Status

North Florida Dermatology Associates

Jacksonville, Florida, United States

Site Status

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Site Status

Grekin Skin Institute

Warren, Michigan, United States

Site Status

Rochester General Medical Group Center for Dermatology at Linden Oaks

Rochester, New York, United States

Site Status

Derm Research Center of NY Inc.

Stoney Brook, New York, United States

Site Status

Wake Resarch

Raleigh, North Carolina, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

TriCities Skin and Cancer

Johnson City, Tennessee, United States

Site Status

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Site Status

Progressive Clinical Research, PA

San Antonio, Texas, United States

Site Status

Dermatology Research Center

Salt Lake City, Utah, United States

Site Status

Virginia Clinical Research Inc.

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CLS001-CO-PR-001

Identifier Type: -

Identifier Source: org_study_id

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