Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel

A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety of Omiganan Topical Gel in Subjects With Rosacea

This study evaluates the long-term safety of once-daily application of Omiganan topical gel in subjects with severe papulopustular rosacea.

Study Overview

• Status: Completed
• Conditions: Rosacea
• Intervention / Treatment: Drug: Omiganan

• Study Type: Interventional
• Enrollment (Actual): 307
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
  • Queensland
    • Woolloongabba, Queensland, Australia
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
  • Quebec
    • Drummondville, Quebec, Canada
• France
  • Cannes, France
  • Nice, France
• Netherlands
  • Bergen Op Zoom, Netherlands
• New Zealand
  • Hamilton, New Zealand
  • Wellington, New Zealand
• Sweden
  • Gothenburg, Sweden
• United Kingdom
  • Lanarkshire, United Kingdom
  • Manchester, United Kingdom
• United States
  • California
    • Fremont, California, United States
  • Florida
    • Miami, Florida, United States
    • Miramar, Florida, United States
    • Tampa, Florida, United States
  • Illinois
    • Arlington Heights, Illinois, United States
  • Indiana
    • Carmel, Indiana, United States
    • Indianapolis, Indiana, United States
    • Plainfield, Indiana, United States
  • Massachusetts
    • Watertown, Massachusetts, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • New York, New York, United States
  • Tennessee
    • Nashville, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Pflugerville, Texas, United States
    • Webster, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy, male and nonpregnant female subjects, 18 years of age or older.
2. A diagnosis of severe papulopustular rosacea using the Investigator Global Assessment grading scale at baseline
3. Subjects with the presence of telangiectasia at Baseline
4. Subjects with the presence of facial erythema associated with their rosacea at Baseline

Exclusion Criteria:

1. Subjects with steroid rosacea or subtype 3 (phymatous rosacea).
2. Subjects with nodular rosacea
3. Standard exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Omiganan gel applied once daily	Drug: Omiganan; Topical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events	Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events	Up to 12 months

Collaborators and Investigators

• Sponsor: Maruho Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): July 14, 2017
• Study Completion (Actual): February 8, 2018

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: CLS001-CO-PR-006