Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

Benign Masseteric Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04294251
• Other study ID #: DW_DWP450301
• Status: Completed
• Phase: Phase 3
• Start date: March 4, 2020
• Est. completion date: August 10, 2021

Study information

• Verified date: July 2020
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 10, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Masseteric Hypertrophy
• Hypertrophy

Intervention

Drug:
• DWP450
Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
• Placebo
Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.

Locations

Country	Name	City	State
Korea, Republic of	Chung-ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in masseter muscle thickness	Change from baseline in masseter muscle thickness by Ultrasonography	12 weeks
Secondary	Change from baseline in masseter muscle thickness	Change from baseline in masseter muscle thickness by Ultrasonography	24 weeks
Secondary	Change from baseline in lower face volume	Change from baseline in lower face volume by 3D digital imaging	24 weeks
Secondary	Overall satisfaction of subject: questionnaire	Subject satisfaction assessment using a scale ranging from very dissatisfied to very satisfied by questionnaire	24 weeks