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 19-100 years
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.