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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
136
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.
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.
Investigator's live assessment of glabella line improvement rate
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown at 4 weeks after the injection.
Time frame: 4 weeks after the injection
Investigator's live assessment of glabella line improvement rate
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown at 10, 16 weeks after the injection
Time frame: 10, 16 weeks after the injection
Investigator's live assessment of glabella line improvement rate
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at rest.
Time frame: 4, 10, 16 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate at maximum frown
Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at maximum frown at 4 weeks after the injection.
Time frame: 4 weeks after the injection
Investigator's photographic assessment of glabella line improvement rate at rest
Glabella line improvement rate determined by investigator's photographic assessment of glabella line severity at rest.
Time frame: 4 weeks after the injection
Subject's satisfaction questionnaire to assess treatment efficacy
Subject's satisfaction questionnaire from score 1 to 7, with 7 being the most satisfied, to assess the glabella line improvement at 4, 10, 16 weeks after the injection.
Time frame: 4, 10, 16 weeks after the injection
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Glabella line improvement rate of subject's assessment
Subject's assessment of glabella line improvement rate at 4, 10, 16 weeks after the injection.
Time frame: 4, 10, 16 weeks after the injection
The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP
The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP from the study start date to the end of study.
Time frame: Through study completion, approximately 8 months