NCT03894748

Efficacy and Safety Study of MT10109L in the Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)

A Parallel, Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10109L Versus BOTOX® in Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study design is multi-center, randomized, double-blind, parallel group, active controlled, phase 3 clinical trial(Including randomized, double-blind, parallel group, active controlled, preliminary study). 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 4 weeks, 10weeks, 16weeks and efficacy and safety assessments will be conducted for total 16 weeks.

Conditions

• Glabella Line Severity

Interventions

Type	Name	Description
DRUG	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: 2011-12-01
• Primary completion: 2012-08-01
• Completion: 2012-10-01
• First posted: 2019-03-28
• Last updated: 2019-03-28

Locations

3 sites across 1 country: South Korea