Back to resultsA Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Omiganan (CLS001) Topical Gel
Vehicle Topical Gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
- Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
- Subjects with ≥ 30 facial inflammatory lesions
Exclusion Criteria:
- Subjects with < 10 or > 75 facial non-inflammatory lesions
- Subjects with > 3 facial nodular or cystic lesions at Baseline
- Standard exclusion criteria
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Vehicle Gel
Arm Description
Omiganan (CLS001) Topical Gel applied once daily
Vehicle Topical Gel applied once daily
Outcomes
Primary Outcome Measures
Absolute change from baseline in inflammatory lesion counts at week 12
Secondary Outcome Measures
Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions
Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02571998
Brief Title
A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
Official Title
A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Multicenter Study to Evaluate the Safety and Efficacy of CLS001 Topical Gel Versus Vehicle Applied Once Daily for 12 Weeks to Female Subjects With Moderate to Severe Acne Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
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 primary objective of this study is to evaluate the safety and efficacy of Omiganan (CLS001) topical gel compared to vehicle topical gel applied once daily for 12 weeks in female subjects with moderate to severe inflammatory acne vulgaris.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Omiganan (CLS001) Topical Gel applied once daily
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Description
Vehicle Topical Gel applied once daily
Intervention Type
Drug
Intervention Name(s)
Omiganan (CLS001) Topical Gel
Intervention Type
Drug
Intervention Name(s)
Vehicle Topical Gel
Primary Outcome Measure Information:
Title
Absolute change from baseline in inflammatory lesion counts at week 12
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions
Time Frame
12 weeks
Title
Percentage of subjects with at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit
Time Frame
12 weeks
Title
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) at each visit
Time Frame
12 weeks
Title
Percentage of subjects with an IGA of Inflammatory Lesions of Acne Vulgaris of clear or almost clear (0 or 1) and at least a two grade reduction in the IGA of Inflammatory Lesions of Acne Vulgaris at each visit.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-pregnant female subjects ≥ 12 years of age with facial acne vulgaris
Subjects with an Investigator's Global Assessment (IGA) of Inflammatory Lesions of Acne Vulgaris of Moderate (3) or Severe (4) at Baseline.
Subjects with ≥ 30 facial inflammatory lesions
Exclusion Criteria:
Subjects with < 10 or > 75 facial non-inflammatory lesions
Subjects with > 3 facial nodular or cystic lesions at Baseline
Standard exclusion criteria
Facility Information:
City
Mobile
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Boca Raton
State/Province
Florida
Country
United States
City
Boynton Beach
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Pinellas Park
State/Province
Florida
Country
United States
City
Sanford
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Beverly
State/Province
Massachusetts
Country
United States
City
Fort Gratiot
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Newington
State/Province
New Hampshire
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
New York
State/Province
New York
Country
United States
City
Stony Brook
State/Province
New York
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Pflugerville
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Webster
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Spokane
State/Province
Washington
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
We'll reach out to this number within 24 hrs