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

Primary Purpose

Benign Masseteric Hypertrophy

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
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
Normal Saline
Sponsored by
Hugel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Masseteric Hypertrophy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hugel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Botulinum Toxin Type A(Botulax®) 24Units

Botulinum Toxin Type A(Botulax®) 48Units

Botulinum Toxin Type A(Botulax®) 72Units

Botulinum Toxin Type A(Botulax®) 96Units

Placebo(Normal Saline)

Arm Description

Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.

Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.

Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.

Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.

Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Amount of change from baseline in masseter muscle thickness during resting
Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography
Rate of change from baseline in masseter muscle thickness during resting
Rate of change from baseline in masseter muscle thickness during resting by Ultrasonography
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
Overall improvement of Investigator
Overall improvement of Investigator by assessment scale
Overall satisfaction of subject
Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire

Full Information

First Posted
June 12, 2020
Last Updated
November 15, 2021
Sponsor
Hugel
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1. Study Identification

Unique Protocol Identification Number
NCT04443244
Brief Title
Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hugel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Masseteric Hypertrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin Type A(Botulax®) 24Units
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.
Arm Title
Botulinum Toxin Type A(Botulax®) 48Units
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.
Arm Title
Botulinum Toxin Type A(Botulax®) 72Units
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.
Arm Title
Botulinum Toxin Type A(Botulax®) 96Units
Arm Type
Experimental
Arm Description
Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.
Arm Title
Placebo(Normal Saline)
Arm Type
Placebo Comparator
Arm Description
Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A Injection (Botulax®) 24Units
Other Intervention Name(s)
Botulax®
Intervention Description
Experimental: Botulax® 24Units
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A Injection (Botulax®) 48Units
Other Intervention Name(s)
Botulax®
Intervention Description
Experimental: Botulax® 48Units
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A Injection (Botulax®) 72Units
Other Intervention Name(s)
Botulax®
Intervention Description
Experimental: Botulax® 72Units
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A Injection (Botulax®) 96Units
Other Intervention Name(s)
Botulax®
Intervention Description
Experimental: Botulax® 96Units
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Placebo Comparator: Normal Saline
Primary Outcome Measure Information:
Title
Amount of change from baseline in masseter muscle thickness during maximum clenching
Description
Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Amount of change from baseline in masseter muscle thickness during maximum clenching
Description
Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
Time Frame
Baseline to week 4, 8, 16
Title
Rate of change from baseline in masseter muscle thickness during maximum clenching
Description
Rate of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
Time Frame
Baseline to week 4, 8, 12, 16
Title
Amount of change from baseline in masseter muscle thickness during resting
Description
Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography
Time Frame
Baseline to week 4, 8, 12, 16
Title
Rate of change from baseline in masseter muscle thickness during resting
Description
Rate of change from baseline in masseter muscle thickness during resting by Ultrasonography
Time Frame
Baseline to week 4, 8, 12, 16
Title
Amount and rate of change from baseline in lower face volume during maximum clenching
Description
Amount and rate of change from baseline in lower face volume during maximum clenching by 3D imaging
Time Frame
Baseline to week 4, 8, 12, 16
Title
Overall improvement of Investigator
Description
Overall improvement of Investigator by assessment scale
Time Frame
Baseline to week 4, 8, 12, 16
Title
Overall satisfaction of subject
Description
Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire
Time Frame
Baseline to week 4, 8, 12, 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hugel
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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