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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Papulopustular Rosacea

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in inflammatory lesion count

Outcome Time Frame:

0, 1, 3, 6, 9 and 12 weeks

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CLS001-CO-PR-001

NCT ID:

NCT01784133

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Papulopustular Rosacea
  • rosacea
  • Rosacea

Name

Location

Tennessee Clinical Research CenterNashville, Tennessee  37221
Grekin Skin InstituteWarren, Michigan  48093
Dermatology Research CenterSalt Lake City, Utah  84117
TriCities Skin and CancerJohnson City, Tennessee  37604
Progressive Clinical Research, PASan Antonio, Texas  78229
Radiant Research Inc.Birmingham, Alabama  35209
The Savin Center, PCNew Haven, Connecticut  06511
Dunedin Research SpecialistsDunedin, Florida  34698
Norht Florida Dermatology AssociatesJacksonville, Florida  32204
Dawes Fretzin Clinical Research GroupIndianapolis, Indiana  46256
Derm Research Center of NY Inc.Stoney Brook, New York  11790
Wake ResarchRaleigh, North Carolina  27612
Oregaon Dermatology and Research CenterPortland, Oregon  97210
Virginia Clinical Research Inc.Norfolk, Virginia  23507