Chung-Ang University Hospital
Dongjak, Seoul, South Korea
NCT Number: NCT05964257
A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign Masseteric hypertrophy
This study is active but is not currently recruiting participants.
Notify Me19 year and older
All sexes
Interventional
Phase 3
Dongjak, Seoul, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
Time frame: 12weeks
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Time frame: 4, 8, 16, 20, 24weeks
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Time frame: 4, 8, 12, 16, 20, 24weeks
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Time frame: 4, 8, 12, 16, 20, 24weeks
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Time frame: 4, 8, 12, 16, 20, 24weeks
The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Time frame: 4, 8, 12, 16, 20, 24weeks
When measuring, the volume of the lower face was measured twice and the average value was used.
Time frame: 4, 8, 12, 16, 20, 24weeks
When measuring, the volume of the lower face was measured twice and the average value was used.
Time frame: 4, 8, 12, 16, 20, 24weeks
Overall improvement criteria: +4 (100% complete improvement) ~ -4 (100% very marked worsening)
Time frame: 4, 8, 12, 16, 20, 24weeks
Overall satisfaction criteria: grade 1 (very dissatisfied) ~ grade 7 (very satisfied), Grade 6 or higher (satisfied, very satisfied) is evaluated as satisfied.
Time frame: 4, 8, 12, 16, 20, 24weeks
MMHS Evaluation criteria: The facial contour and the condition of the bilateral masseter muscles are assessed on a scale from grade 1 (minimal) to grade 5 (very marked).
Huons Biopharma
Industry
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of LIZTOX in Subjects with Benign Masseteric Hypertrophy.
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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