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

NCT05964257 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-09-26

No results posted yet for this study

Summary

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

Conditions

  • Benign Masseteric Hypertrophy

Interventions

DRUG

Botulinum toxin type A

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

DRUG

normal Saline

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

Sponsors & Collaborators

  • Huons Biopharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-25
Primary Completion
2024-03-07
Completion
2025-05-30

Countries

  • South Korea

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05964257 on ClinicalTrials.gov