Botulinum toxin type A(Botulax®)
DrugSingle administration, Day 0, 20 units
NCT Number: NCT01791920
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Chung-Ang University Hopspital, Seoul, Dongjak-gu, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single administration, Day 0, 20 units
Single administration, Day 0, 20units
Time frame: at 4 weeks post-injection
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.
Time frame: 4, 8, 12, 16 weeks post-injection
Time frame: 8, 12, 16 weeks post-injection
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection.
Time frame: 4, 8, 12, 16 weeks post-injection
Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injection
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post inejection
Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injections
Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injection
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
Hugel
Industry
Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe 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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