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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Glabellar Frown Lines

Intervention / Treatment
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* Drug: Botox (Botulinum toxin type A)
* Drug: MT10107 (Botulinum toxin type A)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botox (Botulinum toxin type A)<br>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)<br>* 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.<br>Drug: MT10107 (Botulinum toxin type A)<br>* 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.<br>|
| Experimental: MT10107 (Botulinum toxin type A)<br>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)<br>* 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.<br>Drug: MT10107 (Botulinum toxin type A)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glabella line, Glabella lines, Botulinum Toxin