To Evaluate the Efficacy and Safety of LIZTOX in Subjects With Benign Masseteric Hypertrophy

Phase 3

Recruiting

• Conditions: Benign Masseteric Hypertrophy
• Interventions: Drug: normal Saline; Drug: Botulinum toxin type A

• Registration Number: NCT05964257
• Lead Sponsor: Huons Biopharma

Brief Summary

A double-blind, randomized, placebo-controlled, multi-center, phase III study to evaluate the efficacy and safety of LIZTOX in subjects with benign massesric hypertrophy

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-18
• Study Start: 2023-07-25
• Study First Submitted QC: 2023-07-26
• Last Update Submitted: 2023-07-26
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Primary Completion: 2024-11-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Male or female subject over 19 years of age and written informed consent is obtained.
• Subject who has bisymmetry of masseter at visual and palpable assessment.
• Subject who meets thickness of masseter muscle by ultrasonography.
• Subject who has a scale of benign masseter hypertrophy of 4 or more as determined by investigator.
• Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.

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Exclusion Criteria

• Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
• Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 48 weeks prior to the study entry.
• Subject who has a disease(e.g. Temporo mandibular joint disorder, etc.)
• Subject who were diagnosed Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might influence with neuromuscular function.
• Subject who had taken medication(e.g. muscle relaxant, polypeptide antibiotics, aminoglycoside antibiotics, etc.) within 4 weeks prior to the study entry.
• Subject with known hypersensitivity to botulinum toxin.
• Subject who are pregnant or lactating or planing pregnancy or disagreed to avoid pregnancy during study period.
• Subject who participate other clinical trials within 4 weeks prior to the study entry.
• Subject who are not eligible for this study at the discretion of the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	normal Saline	-
HU-014	Botulinum toxin type A	-

Primary Outcome Measures

Name	Time	Method
Average change from baseline in masseter muscle thickness on both sides at maximum clenching	12weeks	The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.

Secondary Outcome Measures

Name	Time	Method
Average change from baseline in masseter muscle thickness on both sides at maximum clenching	4, 8, 16, 20, 24weeks	The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.
Average change from baseline in masseter muscle thickness on both sides at rest	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.
Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching	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.
Average rate change from baseline in masseter muscle thickness on both sides at rest	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.
Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging	4, 8, 12, 16, 20, 24weeks	When measuring, the volume of the lower face was measured twice and the average value was used.
Rate of change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging	4, 8, 12, 16, 20, 24weeks	When measuring, the volume of the lower face was measured twice and the average value was used.
The proportion of subjects who reported an overall improvement of more than 50% at maximum clenching and at rest.	4, 8, 12, 16, 20, 24weeks	Overall improvement criteria: +4 (100% complete improvement) \~ -4 (100% very marked worsening)
The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest	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.
The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3	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).

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Dongjak, Seoul, Korea, Republic of