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Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CLS001 Topical Gel
CLS001 Topical Gel Vehicle
Sponsored by
Maruho Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older.
  • Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules.
  • An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4)

Exclusion Criteria:

  • Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.)
  • Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose)
  • Subjects with more than 2 facial nodulocystic lesions

Sites / Locations

  • Encino Research Center
  • Skin Surgery Medical Group, Inc.
  • Clinical Science Institute
  • Skin Care Research, Inc.
  • Belleair Research Center
  • Moore Clinical Research, Inc.
  • Kenneth R. Beer, MD, PA
  • MedaPhase, Inc.
  • Hamzavi Dermatology
  • Minnesota Clinical Study Center
  • Academic Dermatology Associates
  • Manhattan Dermatology & Cosmetic Center
  • Derm Research Center of New York, Inc.
  • Dermatology Consulting Services
  • Wake Research Associates
  • Tennessee Clinical Research Center
  • Premier Research
  • J & S Studies, Inc.
  • Progressive Clinical Research, PA
  • Premier Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Vehicle Gel

CLS001 topical gel 1%

CLS001 topical gel 1.75%

CLS001 topical gel 2.5%

Arm Description

Topical application once daily

Topical application once daily

Topical application once daily

Outcomes

Primary Outcome Measures

Change in inflammatory lesion count from Baseline

Secondary Outcome Measures

Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions
Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions
Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit
Percentage of subjects with a 2 grade reduction in the IGA at each visit

Full Information

First Posted
February 18, 2014
Last Updated
September 1, 2015
Sponsor
Maruho Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02066545
Brief Title
Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris
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 Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 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

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of once-daily topical application of CLS001 1%, 1.75% and 2.5% topical gel compared to vehicle topical gel in subjects with 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
327 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Arm Title
CLS001 topical gel 1%
Arm Type
Experimental
Arm Description
Topical application once daily
Arm Title
CLS001 topical gel 1.75%
Arm Type
Experimental
Arm Description
Topical application once daily
Arm Title
CLS001 topical gel 2.5%
Arm Type
Experimental
Arm Description
Topical application once daily
Intervention Type
Drug
Intervention Name(s)
CLS001 Topical Gel
Intervention Type
Drug
Intervention Name(s)
CLS001 Topical Gel Vehicle
Primary Outcome Measure Information:
Title
Change in inflammatory lesion count from Baseline
Time Frame
6, 9 and 12 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline at each visit in inflammatory lesions, non-inflammatory lesions and total lesions
Time Frame
1, 3, 6, 9 and 12 weeks
Title
Absolute change from Baseline at each visit in inflammatory lesions, no-inflammatory lesions, and total lesions
Time Frame
1, 3, 6, 9 and 12 weeks
Title
Percentage of subjects with an Investigator's Global Assessment (IGA) of clear or almost clear (0 or 1) at each visit
Time Frame
1, 3, 6, 9, and 12 weeks
Title
Percentage of subjects with a 2 grade reduction in the IGA at each visit
Time Frame
1, 3, 6, 9, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant female subjects with facial acne vulgaris, 12 years of age or older. Subjects with ≥20 inflammatory facial lesions (papules, pustules) inclusive of the nose, with a maximum of 9 inflammatory pustules. An Investigator's Global Assessment (IGA) of Moderate (3) or Severe (4) Exclusion Criteria: Subjects with acne conglobate, acne fulminans, and secondary acne (chloracne, drug-induced acne, polycystic ovarian syndrome, etc.) Subjects with greater that 75 facial non-inflammatory lesions (open and/or closed comedones; excluding the nose) Subjects with more than 2 facial nodulocystic lesions
Facility Information:
Facility Name
Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Skin Surgery Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Skin Care Research, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Belleair Research Center
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Moore Clinical Research, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Kenneth R. Beer, MD, PA
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Hamzavi Dermatology
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Manhattan Dermatology & Cosmetic Center
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Derm Research Center of New York, Inc.
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
Premier Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
J & S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Premier Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris

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