A Twelve Week Safety and Efficacy Study in Rosacea
This study has been completed.
Sponsor:
Cutanea Life Sciences, Inc.
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
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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
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 March 02, 2015