Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Phase 3

Completed

• Conditions: Benign Masseteric Hypertrophy
• Interventions: Drug: DWP450; Drug: Placebo

• Registration Number: NCT04294251
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-03
• Study Start: 2020-03-04
• Study First Posted: 2020-03-04
• Status Verified: 2020-07
• Primary Completion: 2021-01-07
• Study Completion: 2021-08-10
• Last Update Submitted: 2022-11-28
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DWP450	DWP450	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in masseter muscle thickness	12 weeks	Change from baseline in masseter muscle thickness by Ultrasonography

Secondary Outcome Measures

Name	Time	Method
Change from baseline in lower face volume	24 weeks	Change from baseline in lower face volume by 3D digital imaging
Change from baseline in masseter muscle thickness	24 weeks	Change from baseline in masseter muscle thickness by Ultrasonography
Overall satisfaction of subject: questionnaire	24 weeks	Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire

Trial Locations

Locations (1)

Chung-ang University Hospital; 🇰🇷 Seoul, Korea, Republic of