Papulopustular Rosacea Clinical Trial
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
| NCT number | NCT01784133 |
| Other study ID # | CLS001-CO-PR-001 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | February 1, 2013 |
| Last updated | May 1, 2015 |
| Start date | March 2013 |
| Verified date | May 2015 |
| Source | Cutanea Life Sciences, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 240 |
| Est. completion date | |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Radiant Research Inc. | Birmingham | Alabama |
| United States | Skin Care Research, Inc | Boca Raton | Florida |
| United States | Dunedin Research Specialists | Dunedin | Florida |
| United States | Dawes Fretzin Clinical Research Group | Indianapolis | Indiana |
| United States | North Florida Dermatology Associates | Jacksonville | Florida |
| United States | TriCities Skin and Cancer | Johnson City | Tennessee |
| United States | Tennessee Clinical Research Center | Nashville | Tennessee |
| United States | The Savin Center, PC | New Haven | Connecticut |
| United States | Virginia Clinical Research Inc. | Norfolk | Virginia |
| United States | Oregon Dermatology and Research Center | Portland | Oregon |
| United States | Wake Resarch | Raleigh | North Carolina |
| United States | Rochester General Medical Group Center for Dermatology at Linden Oaks | Rochester | New York |
| United States | Dermatology Research Center | Salt Lake City | Utah |
| United States | Progressive Clinical Research, PA | San Antonio | Texas |
| United States | ATS Clinical Research | Santa Monica | California |
| United States | Derm Research Center of NY Inc. | Stoney Brook | New York |
| United States | Grekin Skin Institute | Warren | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Cutanea Life Sciences, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in inflammatory lesion count | 0, 1, 3, 6, 9 and 12 weeks | No | |
| Secondary | Success on IGA defined as clear or almost clear | Week 12 | No |
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