A Twelve Week Safety and Efficacy Study in Rosacea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier:
NCT01784133
First received: February 1, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Papulopustular Rosacea
Drug: omiganan
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Cutanea Life Sciences, Inc.:

Primary Outcome Measures:
  • Change in inflammatory lesion count [ Time Frame: 0, 1, 3, 6, 9 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Success on IGA defined as clear or almost clear [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: March 2013
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784133

Locations
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.
  More Information

No publications provided

Responsible Party: Cutanea Life Sciences, Inc.
ClinicalTrials.gov Identifier: NCT01784133     History of Changes
Other Study ID Numbers: CLS001-CO-PR-001
Study First Received: February 1, 2013
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cutanea Life Sciences, Inc.:
rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on August 18, 2014