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

Phase 2

Completed

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

• Registration Number: NCT04443244
• Lead Sponsor: Hugel

Brief Summary

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

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 Timeline

• Study Start: 2020-05-27
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-23
• Primary Completion: 2020-11-18
• Study Completion: 2021-07-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin Type A(Botulax®) 48Units	Botulinum Toxin Type A Injection (Botulax®) 48Units	Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.
Botulinum Toxin Type A(Botulax®) 72Units	Botulinum Toxin Type A Injection (Botulax®) 72Units	Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.
Botulinum Toxin Type A(Botulax®) 24Units	Botulinum Toxin Type A Injection (Botulax®) 24Units	Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.
Botulinum Toxin Type A(Botulax®) 96Units	Botulinum Toxin Type A Injection (Botulax®) 96Units	Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.
Placebo(Normal Saline)	Normal Saline	Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.

Primary Outcome Measures

Name	Time	Method
Amount of change from baseline in masseter muscle thickness during maximum clenching	Baseline to week 12	Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hugel; 🇰🇷 Seoul, Korea, Republic of