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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    Hugel
Updated on 19 February 2024

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 Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax in Subjects with Benign Masseteric Hypertrophy

Details
Condition Benign Masseteric Hypertrophy
Age 19years - 100years
Treatment Normal saline, Botulinum Toxin Type A Injection (Botulax®) 24Units, Botulinum Toxin Type A Injection (Botulax®) 48Units, Botulinum Toxin Type A Injection (Botulax®) 72Units, Botulinum Toxin Type A Injection (Botulax®) 96Units
Clinical Study IdentifierNCT04443244
SponsorHugel
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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