A Twelve Week Safety and Efficacy Study in Rosacea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01784133
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : May 20, 2015
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Papulopustular Rosacea Drug: omiganan Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2013
Actual Primary Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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

Primary Outcome Measures :
  1. Change in inflammatory lesion count [ Time Frame: 0, 1, 3, 6, 9 and 12 weeks ]

Secondary Outcome Measures :
  1. Success on IGA defined as clear or almost clear [ Time Frame: Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784133

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

Responsible Party: Cutanea Life Sciences, Inc. Identifier: NCT01784133     History of Changes
Other Study ID Numbers: CLS001-CO-PR-001
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015

Keywords provided by Cutanea Life Sciences, Inc.:

Additional relevant MeSH terms:
Skin Diseases