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
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
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