Botulinum Toxin Type A(Meditoxin®)
Drugsingle administration, Day 0, 20U
Other names: Neuronox®, Siax®
NCT Number: NCT01237977
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.
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Notify Me20 year–65 year
All sexes
Interventional
Phase 3
Seoul National University Bundang Hospital, Seongnam-si, Gyoung-gi Do, South Korea
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single administration, Day 0, 20U
Other names: Neuronox®, Siax®
single administration, Day 0, 20U
Time frame: 0 and 4 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity at baseline and 4 weeks after the injection
Time frame: 0, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection
Time frame: 0, 4, 8,12 and 16 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection
Time frame: 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection
Time frame: 4, 8, 12 and 16 weeks after the injection
Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection
Medy-Tox
Industry
Double-blind, Randomized, Active Drug Comparative, Parallel Designed, Multi-center,Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of "Meditoxin® Versus Botox® in the Treatment of Glabellar Lines
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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