MEDITOXIN® Treatment in Subject With Benign Masseteric Hypertrophy

Medytox

Status and phase: Completed; Phase 3

Conditions: Masseter Muscle Hypertrophy

Treatments: Drug: Meditoxin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03452345

MT01-KR17BMH305

Details and patient eligibility

About

To evaluate the efficacy and safety of MEDITOXIN in subjects with benign masseteric hypertrophy compared with placebo

Enrollment: 180 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subject who aged 20 to less than 65 years
• subject with benign masseteric hypertrophy

Exclusion criteria

• subject not appropriate for participating in this study according to the investigator's opinion
• subject with known an anaphylactic response to BoNT/A and other involved ingredients of Investigational product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

MEDITOXIN

Experimental group

Treatment:

Drug: Meditoxin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo