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OpenTrials
Completed

NCT Number: NCT03289169

Long-term Safety and Efficacy of MEDITOXIN® in Treatment Glabellar Lines

This study evaluates the long-term safety of repeated administrations of Meditoxin® in the treatment of moderate to severe glabellar lines.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Paul Hospital

Seoul, 130-709, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged between 20 and 65
  • Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
  • Patients who can comply with the study procedures and visit schedule
  • Patients who voluntarily sign the informed consent

Exclusion criteria

  • Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
  • Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
  • Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
  • Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
  • Patients who were injected with botulinum toxin within the past 3 months
  • Patients with allergy or hypersensitivity to the investigational drugs or their components
  • Patients who have bleeding tendency or taking anti-coagulant
  • Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
  • Patients with skin disorders or infection at the injection site
  • Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
  • Patients who are unable to communicate or follow the instructions
  • Patients who are not eligible for this study based on the judgment of an investigator

Treatment and study plan

MEDITOXIN®

Drug

20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.

Other names: Neuronox®

Primary outcomes

  1. Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment

    Time frame: 4 weeks after final injection

    improvement are defined as subjects with glabellar line severity of none (0) or mild (1).

Secondary outcomes

  1. Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment

    Time frame: 4 weeks after each injection

    Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment at 4 weeks after each injection

  2. Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment

    Time frame: 4 weeks after each injection

    Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment at 4 weeks after each injection

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

A Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2017
Registry last updated
Aug 27, 2020

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.

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