Efficacy and Safety Study of MT10107 in the Treatment of Glabella Line

A Parallel, Active Drug Controlled, Double Blind, Randomized, Multi-center, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10107 Versus BOTOX® in Treatment of Glabella Line

This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: Botox (Botulinum toxin type A); Drug: MT10107 (Botulinum toxin type A)

Detailed Description

This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a total of 20U (4U/0.1ml each) in five sites of the glabella line. Thereafter, follow-up visits will be made at 4 weeks, 10 weeks, 16 weeks and the efficacy and safety assessments will be conducted for a total of 16 weeks.

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
• Men and women aged between 20 and 65
• Patients who him/herself or him/her legal representatives voluntarily signed the informed consent
• Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

• Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
• Patients who have bleeding tendency or taking anti-coagulant
• Patients suffering from acute diseases
• Patients who have been injected with botulinum toxin within past 3 months before the injection
• Patients with allergy or hypersensitivity to the investigational products or their components
• Patients who are pregnant or lactating or found to be pregnant through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
• Patients who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, benzodiazepine, aminoglycoside antibiotics, other antibiotics, and anticholinergic drugs.
• Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
• Patients with skin damage or infection at the injection site.
• Patients who scheduled a double eyelid operation during the clinical trial.
• Patients who have received or have a plan to receive other procedures, which may affect glabella and forehead lines within 6 months
• Patients whose glabella lines cannot be spread apart even with physical methods like using hands.
• Patients who are participating in other clinical trials or have participated in other clinical trials within 30 days of the screening date.
• Patients who are unable to communicate or follow the instructions
• Patients who are not eligible for this study at the discretion of the investigator

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botox (Botulinum toxin type A); 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.	Drug: Botox (Botulinum toxin type A); 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.; Drug: MT10107 (Botulinum toxin type A); 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
Experimental: MT10107 (Botulinum toxin type A); 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.	Drug: Botox (Botulinum toxin type A); 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.; Drug: MT10107 (Botulinum toxin type A); 20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's live assessment of glabella line improvement rate	Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown at 4 weeks after the injection.	4 weeks after the injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator's live assessment of glabella line improvement rate	Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown at 10, 16 weeks after the injection	10, 16 weeks after the injection
Investigator's live assessment of glabella line improvement rate	Glabella line improvement rate determined by investigator's live assessment of glabella line severity at rest.	4, 10, 16 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate at maximum frown	Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at maximum frown at 4 weeks after the injection.	4 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate at rest	Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at rest.	4 weeks after the injection
Subject's satisfaction questionnaire to assess treatment efficacy	Subject's satisfaction questionnaire from score 1 to 7, with 7 being the most satisfied, to assess the glabella line improvement at 4, 10, 16 weeks after the injection.	4, 10, 16 weeks after the injection
Glabella line improvement rate of subject's assessment	Subject's assessment of glabella line improvement rate at 4, 10, 16 weeks after the injection.	4, 10, 16 weeks after the injection
The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP	The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP from the study start date to the end of study.	Through study completion, approximately 8 months

Collaborators and Investigators

• Sponsor: Medy-Tox
• Investigators: Study Chair: Huh Changhun, M.D., Seoul National University Bundang Hospital; Principal Investigator: Yangwon Lee, M.D., Konkuk University Hospital; Principal Investigator: Jonghee Lee, M.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: April 7, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Botulinum Toxin; Glabella line; Glabella lines
• 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: MT_PRT_GL03

Drug and device information, study documents

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