Efficacy and Safety of DWP450 in Subjects With Benign Mas... | NCT04294251

Studies
Efficacy and Safety of DWP450 in Subjects With Benign Masseteric Hypertrophy

NCT04294251

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Nov 30, 2022Actual

Enrollment

180Actual

Phase

Phase 3

Conditions

Benign Masseteric Hypertrophy

Interventions

DWP450
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2020Actual

Primary Completion Date

Jan 7, 2021Actual

Completion Date

Aug 10, 2021Actual

First Submitted Date

Mar 2, 2020

First Submission Date that Met QC Criteria

Mar 3, 2020

First Posted Date

Mar 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2022

Last Update Posted Date

Nov 30, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DWP450	Experimental		Drug: DWP450
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWP450	Drug	Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.	DWP450

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in masseter muscle thickness	Change from baseline in masseter muscle thickness by Ultrasonography	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in masseter muscle thickness	Change from baseline in masseter muscle thickness by Ultrasonography	24 weeks
Change from baseline in lower face volume	Change from baseline in lower face volume by 3D digital imaging

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 facial aesthetic procedure (e.g. surgery, laser, thread treatment etc.) in lower facial area within 52 weeks prior to the study entry.
Subject who had previously received botulinum toxin within 12 weeks 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided