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

Medytox

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Drug: MT10107 (Botulinum toxin type A); Drug: Botox (Botulinum toxin type A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03908008

MT_PRT_GL03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups

Botox (Botulinum toxin type A)

Active Comparator group

Description:

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.

Treatment:

Drug: Botox (Botulinum toxin type A)

Drug: MT10107 (Botulinum toxin type A)

MT10107 (Botulinum toxin type A)

Experimental group

Description:

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.

Treatment:

Drug: Botox (Botulinum toxin type A)

Drug: MT10107 (Botulinum toxin type A)