DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

Daewoong Pharmaceutical

Status and phase

Unknown

Phase 2

Conditions

Benign Masseteric Hypertrophy

Treatments

Drug: Placebos

Drug: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT03369990

DW_DWP450008

Details and patient eligibility

About

This study is A Randomized, Double-blind, Placebo-controlled, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of DWP450 in Subjects with Benign Masseteric Hypertrophy

Enrollment

98 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subject over 18 years of age and written informed consent is obtained.
Subject with Benign Masseter Hypertrophy
Subject who has Bisymmetry of masseter at visual assessment.
Subjects who meets thickness of Masseter muscle by ultrasonography.
Subjects who can and will comply with the requirements of the protocol.

Exclusion criteria

Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
Subject who got any treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
Subject who had previously received botulinum toxin within 3 months prior to the study entry
Subject with known hypersensitivity to botulinum toxin
Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
Subjects who are not eligible for this study at the discretion of the investigator