This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Clostridium botulinum type A (Hall group); a lyophilized white power for injection with a colorless transparent vial. colorless transparent solution when dissolved with saline.
Severance Hospital
Seoul, South Korea
Investigator-rated improvement rate of glabellar lines at maximum frown at Week 4 of each treatment cycle
Improvement rate: improvement of Facial Wrinkle Scale score from 3 (moderate) or 4 (severe) to 0 (none) or 1 (mild)
Time frame: At Week 4 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Subject-rated improvement rate of glabellar lines at maximum frown
Time frame: Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Subject-rated satisfaction at each cycle after treatment
Time frame: Every 4 weeks in each treatment cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment on-set date
Time frame: From baseline to Day 7 of each cycle (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Treatment duration
Time frame: From on-set date to next treatment (each cycle lasts until re-treatment, where re-treatment is possible after 90 Days from the last treatment).
Number of participants who experienced an adverse event
Time frame: Baseline to Day 720
Number of participants with binding and neutralizing antibodies
Time frame: Screening and Day 720
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