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NCT Number: NCT05964257

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chung-Ang University Hospital

Dongjak, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subject over 19 years of age and written informed consent is obtained.
  • Subject who has bilaterally symmetrical of masseter at visual and palpable assessment.
  • Subject who average masseter muscle thickness of at least 14mm on each side in males and 12mm in females at maximum clenching by ultrasonography.
  • Subject who has a masseter muscle hypertrophy scale of 4(marked) or more as determined by investigator.
  • Subject who fully understands this clinical trial and voluntarily writes ICF in the clinical trial.

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 masseter muscle 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, Lambert-Eaton 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 who are hypersensitive to investigational drug components (botulinum toxin, serum albumin, etc.)
  • 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.

Treatment and study plan

Botulinum Toxin Type A

Drug

Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.

normal saline

Drug

Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.

Primary outcomes

  1. Average change from baseline in masseter muscle thickness on both sides at maximum clenching

    Time frame: 12weeks

    The thickness of the masseter muscle is measured using ultrasonography, and the average value is obtained from three measurements.

Secondary outcomes

  1. Average change from baseline in masseter muscle thickness on both sides at maximum clenching

    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.

  2. Average change from baseline in masseter muscle thickness on both sides at rest

    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.

  3. Average rate change from baseline in masseter muscle thickness on both sides at maximum clenching

    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.

  4. Average rate change from baseline in masseter muscle thickness on both sides at rest

    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.

  5. Change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging

    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.

  6. Rate of change from baseline in the lower facial volume at maximum clenching and at rest using Morpheus 3D imaging

    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.

  7. The proportion of subjects who reported an overall improvement of more than 50% at maximum clenching and at rest.

    Time frame: 4, 8, 12, 16, 20, 24weeks

    Overall improvement criteria: +4 (100% complete improvement) ~ -4 (100% very marked worsening)

  8. The proportion of subjects who rated overall satisfaction as 'satisfied' at maximum clenching and at rest

    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.

  9. The proportion of subjects with a masseter muscle hypertrophy scale (MMHS) ≤3

    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).

Sponsors and collaborators

Lead sponsor

Huons Biopharma

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 27, 2023
Registry last updated
Sep 26, 2024

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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