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

NCT ID: NCT03908008

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-09-30

Brief Summary

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

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.

Conditions

Glabellar Frown Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Botox (Botulinum toxin type A)

Intervention Type: DRUG

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.

MT10107 (Botulinum toxin type A)

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Botox (Botulinum toxin type A)

Intervention Type: DRUG

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.

MT10107 (Botulinum toxin type A)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huh Changhun, M.D.

Role: STUDY_CHAIR

Seoul National University Bundang Hospital

Yangwon Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Hospital

Jonghee Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Other Identifiers

MT_PRT_GL03

Identifier Type: -

Identifier Source: org_study_id