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A Twelve Week Safety and Efficacy Study in Rosacea

Primary Purpose

Papulopustular Rosacea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
omiganan
placebo
Sponsored by
Maruho Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Papulopustular Rosacea focused on measuring rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radiant Research Inc.
  • ATS Clinical Research
  • The Savin Center, PC
  • Skin Care Research, Inc
  • Dunedin Research Specialists
  • North Florida Dermatology Associates
  • Dawes Fretzin Clinical Research Group
  • Grekin Skin Institute
  • Rochester General Medical Group Center for Dermatology at Linden Oaks
  • Derm Research Center of NY Inc.
  • Wake Resarch
  • Oregon Dermatology and Research Center
  • TriCities Skin and Cancer
  • Tennessee Clinical Research Center
  • Progressive Clinical Research, PA
  • Dermatology Research Center
  • Virginia Clinical Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

omiganan mid dose

omiganan high dose

Vehicle group

omiganan low dose

Arm Description

omiganan mid dose once daily application for 12 weeks

omiganan high dose once daily application for 12 weeks

Vehicle once daily application for 12 weeks

omiganan low dose once daily application for 12 weeks

Outcomes

Primary Outcome Measures

Change in inflammatory lesion count

Secondary Outcome Measures

Success on IGA defined as clear or almost clear

Full Information

First Posted
February 1, 2013
Last Updated
May 1, 2015
Sponsor
Maruho Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01784133
Brief Title
A Twelve Week Safety and Efficacy Study in Rosacea
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omiganan mid dose
Arm Type
Active Comparator
Arm Description
omiganan mid dose once daily application for 12 weeks
Arm Title
omiganan high dose
Arm Type
Active Comparator
Arm Description
omiganan high dose once daily application for 12 weeks
Arm Title
Vehicle group
Arm Type
Placebo Comparator
Arm Description
Vehicle once daily application for 12 weeks
Arm Title
omiganan low dose
Arm Type
Active Comparator
Arm Description
omiganan low dose once daily application for 12 weeks
Intervention Type
Drug
Intervention Name(s)
omiganan
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Change in inflammatory lesion count
Time Frame
0, 1, 3, 6, 9 and 12 weeks
Secondary Outcome Measure Information:
Title
Success on IGA defined as clear or almost clear
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Radiant Research Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
ATS Clinical Research
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
The Savin Center, PC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Skin Care Research, Inc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Dunedin Research Specialists
City
Dunedin
State/Province
Florida
ZIP/Postal Code
34698
Country
United States
Facility Name
North Florida Dermatology Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Dawes Fretzin Clinical Research Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
Rochester General Medical Group Center for Dermatology at Linden Oaks
City
Rochester
State/Province
New York
ZIP/Postal Code
14625
Country
United States
Facility Name
Derm Research Center of NY Inc.
City
Stoney Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Wake Resarch
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Oregon Dermatology and Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
TriCities Skin and Cancer
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37674
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Virginia Clinical Research Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Twelve Week Safety and Efficacy Study in Rosacea

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