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

November 15, 2021 updated by: Hugel

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Botulinum Toxin Type A(Botulax®) 24Units
Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.
Drug: Botulinum Toxin Type A Injection (Botulax®) 24Units
Experimental: Botulax® 24Units
Other Names:
  • Botulax®
EXPERIMENTAL: Botulinum Toxin Type A(Botulax®) 48Units
Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.
Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units
Experimental: Botulax® 48Units
Other Names:
  • Botulax®
EXPERIMENTAL: Botulinum Toxin Type A(Botulax®) 72Units
Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.
Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units
Experimental: Botulax® 72Units
Other Names:
  • Botulax®
EXPERIMENTAL: Botulinum Toxin Type A(Botulax®) 96Units
Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.
Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units
Experimental: Botulax® 96Units
Other Names:
  • Botulax®
PLACEBO_COMPARATOR: Placebo(Normal Saline)
Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.
Other: Normal Saline
Placebo Comparator: Normal Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline to week 4, 8, 16
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
Baseline to week 4, 8, 12, 16
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
Baseline to week 4, 8, 12, 16
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
Baseline to week 4, 8, 12, 16
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
Baseline to week 4, 8, 12, 16
Overall improvement of Investigator
Time Frame: Baseline to week 4, 8, 12, 16
Overall improvement of Investigator by assessment scale
Baseline to week 4, 8, 12, 16
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
Baseline to week 4, 8, 12, 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hugel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HG-BOTBMH-PII-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Masseteric Hypertrophy

Clinical Trials on Botulinum Toxin Type A Injection (Botulax®) 24Units

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings