Benign Masseteric Hypertrophy
Conditions
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
Interventions
DRUGBotulinum Toxin Type A Injection (Botulax®) 24Units
Experimental: Botulax® 24Units
DRUGBotulinum Toxin Type A Injection (Botulax®) 48Units
Experimental: Botulax® 48Units
DRUGBotulinum Toxin Type A Injection (Botulax®) 72Units
Experimental: Botulax® 72Units
DRUGBotulinum Toxin Type A Injection (Botulax®) 96Units
Experimental: Botulax® 96Units
OTHERNormal Saline
Placebo Comparator: Normal Saline
Sponsors
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of change from baseline in masseter muscle thickness during maximum clenching | Baseline to week 12 | Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of change from baseline in masseter muscle thickness during maximum clenching | Baseline to week 4, 8, 12, 16 | 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 | Baseline to week 4, 8, 12, 16 | Amount of change from baseline in masseter muscle thickness during resting by Ultrasonography |
| Rate 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 by Ultrasonography |
| Amount of change from baseline in masseter muscle thickness during maximum clenching | Baseline to week 4, 8, 16 | Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography |
| Overall improvement of Investigator | Baseline to week 4, 8, 12, 16 | Overall improvement of Investigator by assessment scale |
| Overall satisfaction of subject | Baseline to week 4, 8, 12, 16 | Subject satisfaction assessment using a scale ranging from Extremely dissatisfied to Extremely satisfied by questionnaire |
| Amount and rate of change from baseline in lower face volume during maximum clenching | Baseline to week 4, 8, 12, 16 | Amount and rate of change from baseline in lower face volume during maximum clenching by 3D imaging |
Countries
South Korea
Outcome results
None listed