Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Benign Masseteric Hypertrophy

Treatments: Drug: DWP450; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04294251

DW_DWP450301

Details and patient eligibility

About

This Study is A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
2. Subject who got any facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
3. Subject who had previously received botulinum toxin within 12 weeks prior to the study entry.
4. Subject with known hypersensitivity to botulinum toxin.
5. Subject who are pregnant or lactating or found pregnancy though the urine or sebum test or disagreed to avoid pregnancy during study period.
6. Subjects who are not eligible for this study at the discretion of the investigator.

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

DWP450

Experimental group

Treatment:

Drug: DWP450

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo