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

Benign Masseteric Hypertrophy Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964257
• Other study ID #: HU-014_P3_BMH
• Status: Recruiting
• Phase: Phase 3
• Start date: July 25, 2023
• Est. completion date: May 30, 2025

Study information

• Verified date: July 2023
• Source: Huons Biopharma
• Contact: Ham kiltae
• Phone: +82-02-854-4700
• Email: kiltae.ham[@]HUONS.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: May 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Benign Masseteric Hypertrophy
• Hypertrophy

Intervention

Drug:
• Botulinum toxin type A
Botulinum toxin type A(HU-014) will be administered intramuscularly to the bilateral masseter muscles on Visit 2.
• normal Saline
Normal Saline will be administered intramuscularly to the bilateral masseter muscles on Visit 2.

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Dongjak	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Huons Biopharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in masseter muscle thickness	Change from baseline in masseter muscle thickness by Ultrasonography	12week