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

NCT04443244 | Completed Phase 2

• 1 other identifier: HG-BOTBMH-PII-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Benign Masseteric Hypertrophy

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to week 12

Secondary Outcomes (7)

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

  Baseline to week 4, 8, 16

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

  Baseline to week 4, 8, 12, 16

• Amount of change from baseline in masseter muscle thickness during resting

  Baseline to week 4, 8, 12, 16

• Rate of change from baseline in masseter muscle thickness during resting

  Baseline to week 4, 8, 12, 16

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

  Baseline to week 4, 8, 12, 16

Study Arms (5)

Botulinum Toxin Type A(Botulax®) 24Units

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A Injection (Botulax®) 24Units

Botulinum Toxin Type A(Botulax®) 48Units

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units

Botulinum Toxin Type A(Botulax®) 72Units

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units

Botulinum Toxin Type A(Botulax®) 96Units

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units

Placebo(Normal Saline)

PLACEBO COMPARATOR

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

Other: Normal Saline

Interventions

Botulinum Toxin Type A Injection (Botulax®) 24Units DRUG

Experimental: Botulax® 24Units

Also known as: Botulax®

Botulinum Toxin Type A(Botulax®) 24Units

Botulinum Toxin Type A Injection (Botulax®) 48Units DRUG

Experimental: Botulax® 48Units

Also known as: Botulax®

Botulinum Toxin Type A(Botulax®) 48Units

Botulinum Toxin Type A Injection (Botulax®) 72Units DRUG

Experimental: Botulax® 72Units

Also known as: Botulax®

Botulinum Toxin Type A(Botulax®) 72Units

Botulinum Toxin Type A Injection (Botulax®) 96Units DRUG

Experimental: Botulax® 96Units

Also known as: Botulax®

Botulinum Toxin Type A(Botulax®) 96Units

Normal Saline OTHER

Placebo Comparator: Normal Saline

Placebo(Normal Saline)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hugel: lead

Study Sites (1)

Hugel

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Saline Solution

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 23, 2020
• Study Start: May 27, 2020
• Primary Completion: November 18, 2020
• Study Completion: July 16, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

KR (1)