DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03369990

Enrollment

Registered

2017-12-12

Start date

2017-12-31

Completion date

2018-10-31

Last updated

2017-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Masseteric Hypertrophy

Brief summary

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

Interventions

DRUGBotulinum toxin type A

Botulinum toxin type A(DWP450)

DRUGPlacebos

Normal Saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 treatment, including double jaw surgery, laser, thread treatment etc. in 12 months. 3. Subject who had previously received botulinum toxin within 3 months 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

Design outcomes

Primary

Measure	Time frame	Description
Reduction amount of masseter muscle thickness	At 12 weeks	Reduction amount of masseter muscle thickness by Ultrasonography

Secondary

Measure	Time frame	Description
Reduction amount of masseter muscle thickness	At 4,8,16 weeks	Reduction amount of masseter muscle thickness by Ultrasonography
Reduction amount of lower face volume	At 4, 8, 12, 16 weeks	Reduction amount of lower face volume by 3D digital imaging
Overall satisfaction of subject	At 4, 8, 12, 16 weeks	Overall satisfaction of subject by questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026