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)

Medy-Tox3 sites in 1 country168 target enrollmentDecember 2011

ConditionsGlabella Line Severity

InterventionsBotulinum Toxin Type A

DrugsBotulinum Toxin Type A

Overview

Phase: Phase 2
Intervention: Botulinum Toxin Type A
Conditions: Glabella Line Severity
Sponsor: Medy-Tox
Enrollment: 168
Locations: 3
Primary Endpoint: Investigator's live assessment of glabella line improvement rate
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

October 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medy-Tox

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Main inclusion criteria
•Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
•Other inclusion criteria
•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 pregnancy through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
•\* All childbearing female subjects, excepting who had amenorrhea over 12 months or sterilization operation(bilateral tubal ligation, bilateral oophorrectomy or hysterectomy), shouldn't be enrolled the study until they tested negative on pregnancy test(urine or serum). The contraceptions which are medically allowable are spermicides, oral contraceptives, barrier method, intrauterine contrace, complete sexual abstinence
•Patients who have been given any of the following drugs within previous 4 weeks at screening
•① Muscle relaxants: Tubocurarine Chloride, Dantrolene Sodium, baclofen etc.
•② Spectinomycin HCl

Arms & Interventions

MT10109L(Botulinum toxin type A)

Intervention: Botulinum Toxin Type A

BOTOX® 50U(Botulinum toxin type A)

Intervention: Botulinum Toxin Type A

Outcomes

Primary Outcomes

Investigator's live assessment of glabella line improvement rate

Time Frame: 4 weeks after the injection

Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown

Secondary Outcomes

Investigator's live assessment of glabella line improvement rate(4, 16 weeks after the injection)
Investigator's photographic assessment of glabella line improvement rate(4 weeks after the injection)
Subject's assessment of glabella line improvement rate(4, 10, 16 weeks after the injection)
Subject's satisfaction questionnaire(4, 10, 16 weeks after the injection)
Number of adverse events in subjects(Up to 16 weeks)