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

NCT03894748 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2019-03-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medy-Tox

    lead INDUSTRY

Principal Investigators

  • Hoon Kang, M.D. · Catholic University of Korea Saint Paul's Hospital

  • Gwang Seong Choi, M.D., Ph.D. · Inha University Hospital

  • Woo Young Sim, M.D. · Kyung Hee University Hospital at Gangdong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-08-31
Completion
2012-10-31

Countries

  • South Korea

Study Locations

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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 NCT03894748 on ClinicalTrials.gov