Skip to main content
OpenTrials
Completed

NCT Number: NCT02576847

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Omiganan

Drug

Topical gel

Primary outcomes

  1. Number of Subjects With 1 or More Treatment-related Treatment-Emergent Adverse Events

    Time frame: Up to 12 months

    Number of subjects with 1 or more treatment-related Treatment-Emergent Adverse Events

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 15, 2015
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.