A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris

March 24, 2017 updated by: Maruho Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
    • California
      • Santa Ana, California, United States
      • Santa Monica, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Boca Raton, Florida, United States
      • Boynton Beach, Florida, United States
      • Miami, Florida, United States
      • Pinellas Park, Florida, United States
      • Sanford, Florida, United States
      • Tampa, Florida, United States
    • Massachusetts
      • Beverly, Massachusetts, United States
    • Michigan
      • Fort Gratiot, Michigan, United States
    • Missouri
      • St. Louis, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Newington, New Hampshire, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • New York, New York, United States
      • Stony Brook, New York, United States
    • North Carolina
      • High Point, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Tennessee
      • Knoxville, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Pflugerville, Texas, United States
      • San Antonio, Texas, United States
      • Webster, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Omiganan (CLS001) Topical Gel applied once daily
Drug: Omiganan (CLS001) Topical Gel
Placebo Comparator: Vehicle Gel
Vehicle Topical Gel applied once daily
Drug: Vehicle Topical Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in inflammatory lesion counts at week 12
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute change from Baseline at each visit in inflammatory lesions, non-inflammatory lesions, and total lesions
Time Frame: 12 weeks
12 weeks
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
12 weeks
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
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maruho Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 7, 2015

First Posted (Estimate)

October 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS001-CO-PR-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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