Skip to main content
OpenTrials
Completed

NCT Number: NCT04443244

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Benign Masseteric Hypertrophy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hugel

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Botulinum Toxin Type A Injection (Botulax®) 24Units

Drug

Experimental: Botulax® 24Units

Other names: Botulax®

Botulinum Toxin Type A Injection (Botulax®) 48Units

Drug

Experimental: Botulax® 48Units

Other names: Botulax®

Botulinum Toxin Type A Injection (Botulax®) 72Units

Drug

Experimental: Botulax® 72Units

Other names: Botulax®

Botulinum Toxin Type A Injection (Botulax®) 96Units

Drug

Experimental: Botulax® 96Units

Other names: Botulax®

Normal Saline

Other

Placebo Comparator: Normal Saline

Primary outcomes

  1. Amount of change from baseline in masseter muscle thickness during maximum clenching

    Time frame: Baseline to week 12

    Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography

Secondary outcomes

  1. Amount of change from baseline in masseter muscle thickness during maximum clenching

    Time frame: Baseline to week 4, 8, 16

    Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography

  2. Rate of change from baseline in masseter muscle thickness during maximum clenching

    Time frame: Baseline to week 4, 8, 12, 16

    Rate of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography

  3. Amount of change from baseline in masseter muscle thickness during resting

    Time frame: Baseline to week 4, 8, 12, 16

    Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography

  4. Rate of change from baseline in masseter muscle thickness during resting

    Time frame: Baseline to week 4, 8, 12, 16

    Rate of change from baseline in masseter muscle thickness during resting by Ultrasonography

  5. Amount and rate of change from baseline in lower face volume during maximum clenching

    Time frame: Baseline to week 4, 8, 12, 16

    Amount and rate of change from baseline in lower face volume during maximum clenching by 3D imaging

  6. Overall improvement of Investigator

    Time frame: Baseline to week 4, 8, 12, 16

    Overall improvement of Investigator by assessment scale

  7. Overall satisfaction of subject

    Time frame: Baseline to week 4, 8, 12, 16

    Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.