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

Benign Masseteric Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443244
• Other study ID #: HG-BOTBMH-PII-01
• Status: Completed
• Phase: Phase 2
• Start date: May 27, 2020
• Est. completion date: July 16, 2021

Study information

• Verified date: November 2021
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 16, 2021
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Masseteric Hypertrophy
• Hypertrophy

Intervention

Drug:
• Botulinum Toxin Type A Injection (Botulax®) 24Units
Experimental: Botulax® 24Units
• Botulinum Toxin Type A Injection (Botulax®) 48Units
Experimental: Botulax® 48Units
• Botulinum Toxin Type A Injection (Botulax®) 72Units
Experimental: Botulax® 72Units
• Botulinum Toxin Type A Injection (Botulax®) 96Units
Experimental: Botulax® 96Units

Other:
• Normal Saline
Placebo Comparator: Normal Saline

Locations

Country	Name	City	State
Korea, Republic of	Hugel	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall improvement of Investigator	Overall improvement of Investigator by assessment scale	Baseline to week 4, 8, 12, 16
Secondary	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