NCT03908008

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-05-01
• Completion: 2014-09-01
• First posted: 2019-04-09
• Last updated: 2019-04-10