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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 Center Nashville, Tennessee  37221
Grekin Skin Institute Warren, Michigan  48093
Dermatology Research Center Salt Lake City, Utah  84117
TriCities Skin and Cancer Johnson City, Tennessee  37604
Progressive Clinical Research, PA San Antonio, Texas  78229
Radiant Research Inc. Birmingham, Alabama  35209
The Savin Center, PC New Haven, Connecticut  06511
Dunedin Research Specialists Dunedin, Florida  34698
Norht Florida Dermatology Associates Jacksonville, Florida  32204
Dawes Fretzin Clinical Research Group Indianapolis, Indiana  46256
Derm Research Center of NY Inc. Stoney Brook, New York  11790
Wake Resarch Raleigh, North Carolina  27612
Oregaon Dermatology and Research Center Portland, Oregon  97210
Virginia Clinical Research Inc. Norfolk, Virginia  23507