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

NCT03908008 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2019-04-10

No results posted yet for this study

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.

Conditions

  • Glabellar Frown Lines

Interventions

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.

Sponsors & Collaborators

  • Medy-Tox

    lead INDUSTRY

Principal Investigators

  • Huh Changhun, M.D. · Seoul National University Bundang Hospital

  • Yangwon Lee, M.D. · Konkuk University Hospital

  • Jonghee Lee, M.D. · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-05-31
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03908008 on ClinicalTrials.gov