Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX®

A Single-arm Trial, Open-label, Repeated, Long-term, Multi-center, Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment of Glabellar Lines With CORETOX®

This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.

Study Overview

• Status: Unknown
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: CORETOX Inj

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: Coretox®; Botulinum toxin type A to be intramuscularly injected at 4 sites of corrugator muscle and at 1 site of procerus muscle with 0.1 mL (4U) at each site, for a total of 0.5 mL (20U). The administration of the investigational product was performed once at the start of each cycle	Biological: CORETOX Inj; Clostridium botulinum type A (Hall group); a lyophilized white power for injection with a colorless transparent vial. colorless transparent solution when dissolved with saline.; Other Names: Botulinum toxin type A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who experienced an adverse event		Baseline to Day 720
Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle	Improvement rate: improvement of Facial Wrinkle Scale score from 3 (moderate) or 4 (severe) to 0 (none) or 1 (mild)	At Week 4 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Subject-rated improvement rate of glabellar lines at maximum frown		Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Subject-rated satisfaction at each cycle after treatment		Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment on-set date		From baseline to Day 7 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment duration		From on-set date to next treatment (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Number of participants with binding and neutralizing antibodies		Screening and Day 720

Collaborators and Investigators

• Sponsor: Medy-Tox

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2019
• Primary Completion (ACTUAL): June 17, 2020
• Study Completion (ANTICIPATED): March 16, 2022

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (ACTUAL): February 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: MT03-KR19GBL404

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No