Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
Benign Masseteric Hypertrophy
About this trial
This is an interventional treatment trial for Benign Masseteric Hypertrophy
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.
Sites / Locations
- Hugel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
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)
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.