A Twelve Week Safety and Efficacy Study in Rosacea
This study is currently recruiting participants.
Verified April 2013 by Cutanea Life Sciences, Inc.
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 5, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | November 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784133
Locations
| United States, Alabama | |
| Radiant Research Inc. | Recruiting |
| Birmingham, Alabama, United States, 35209 | |
| Contact: Elizabeth Burke elizabethburke@radiantresearch.com | |
| United States, Florida | |
| Dunedin Research Specialists | Recruiting |
| Dunedin, Florida, United States, 34698 | |
| Contact: Sue Fisher sfisher@dunedinresearch.com | |
| Norht Florida Dermatology Associates | Recruiting |
| Jacksonville, Florida, United States, 32204 | |
| Contact: Furqan Haq fhaq@nfderm.com | |
| United States, Indiana | |
| Dawes Fretzin Clinical Research Group | Recruiting |
| Indianapolis, Indiana, United States, 46256 | |
| Contact: Patti Day pday@ecommunity.com | |
| United States, Michigan | |
| Grekin Skin Institute | Recruiting |
| Warren, Michigan, United States, 48088 | |
| Contact: Claudia Attala cattalia@comcast.net | |
| United States, New York | |
| Derm Research Center of NY Inc. | Recruiting |
| Stoney Brook, New York, United States, 11790 | |
| Contact: Ruth Verspoor rverspoor@drcny.com | |
| United States, North Carolina | |
| Wake Resarch | Recruiting |
| Raleigh, North Carolina, United States, 27612 | |
| Contact: Dhara Vaghari warnews@wakeresearch.com | |
| United States, Oregon | |
| Oregaon Dermatology and Research Center | Recruiting |
| Portland, Oregon, United States, 97210 | |
| Contact: Carly Gibbons 503-226-3376 ext 40 | |
| United States, Tennessee | |
| TriCities Skin and Cancer | Recruiting |
| Johnson City, Tennessee, United States, 37674 | |
| Contact: Tonya Ward-Kiser TWard-Kiser@pmg-research.com | |
| Tennessee Clinical Research Center | Recruiting |
| Nashville, Tennessee, United States, 37215 | |
| Contact: Whitney Sensing wsensing@tnclinicalresearch.com | |
| United States, Texas | |
| Progressive Clinical Research, PA | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Contact: Cindy Garza drlee@progclin.com | |
| United States, Utah | |
| Dermatology Research Center | Recruiting |
| Salt Lake City, Utah, United States, 84117 | |
| Contact: Kim Davenport kim@dermatologyresearch.net | |
| United States, Virginia | |
| Virginia Clinical Research Inc. | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Erin Riveria eriveria@vcrinc.org | |
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 5, 2013 |
| 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 May 23, 2013