Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy

This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

Study Overview

• Status: Completed
• Conditions: Benign Masseteric Hypertrophy
• Intervention / Treatment: Drug: Botulinum Toxin Type A Injection (Botulax®) 24Units; Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units; Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units; Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units; Other: Normal Saline

Detailed Description

A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Hugel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and Female adults aged 19 or older.
2. Sighting, facilitation measurement are judged by the investigator to be the ratio of Benign Masseteric Hypertrophy.
3. Subject who understand and willing to perform with the procedures and visiting schedules of clinical trial.
4. Subject who voluntarily agree to participate in this clinical trial.

Exclusion Criteria:

1. Subject who is clinically significant facial asymmetry in visual measurement by the investigator.
2. Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
3. Subject who is deemed unable to participate in a clinical trial under the judgement of a Investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Botulinum Toxin Type A(Botulax®) 24Units; Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.	Drug: Botulinum Toxin Type A Injection (Botulax®) 24Units; Experimental: Botulax® 24Units; Other Names: Botulax®
EXPERIMENTAL: Botulinum Toxin Type A(Botulax®) 48Units; Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.	Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units; Experimental: Botulax® 48Units; Other Names: Botulax®
EXPERIMENTAL: Botulinum Toxin Type A(Botulax®) 72Units; Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.	Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units; Experimental: Botulax® 72Units; Other Names: Botulax®
EXPERIMENTAL: Botulinum Toxin Type A(Botulax®) 96Units; Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.	Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units; Experimental: Botulax® 96Units; Other Names: Botulax®
PLACEBO_COMPARATOR: Placebo(Normal Saline); Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.	Other: Normal Saline; Placebo Comparator: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of change from baseline in masseter muscle thickness during maximum clenching	Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography	Baseline to week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of change from baseline in masseter muscle thickness during maximum clenching	Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography	Baseline to week 4, 8, 16
Rate of change from baseline in masseter muscle thickness during maximum clenching	Rate of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography	Baseline to week 4, 8, 12, 16
Amount of change from baseline in masseter muscle thickness during resting	Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography	Baseline to week 4, 8, 12, 16
Rate of change from baseline in masseter muscle thickness during resting	Rate of change from baseline in masseter muscle thickness during resting by Ultrasonography	Baseline to week 4, 8, 12, 16
Amount and rate of change from baseline in lower face volume during maximum clenching	Amount and rate of change from baseline in lower face volume during maximum clenching by 3D imaging	Baseline to week 4, 8, 12, 16
Overall improvement of Investigator	Overall improvement of Investigator by assessment scale	Baseline to week 4, 8, 12, 16
Overall satisfaction of subject	Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire	Baseline to week 4, 8, 12, 16

Collaborators and Investigators

• Sponsor: Hugel

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 27, 2020
• Primary Completion (ACTUAL): November 18, 2020
• Study Completion (ACTUAL): July 16, 2021

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (ACTUAL): June 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: HG-BOTBMH-PII-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No