DWP450 Treatment in Subjects With Benign Masseteric Hyper... | NCT03369990

Studies
DWP450 Treatment in Subjects With Benign Masseteric Hypertrophy

NCT03369990

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Unknown status

Last Update Posted

Dec 12, 2017Actual

Enrollment

98Estimated

Phase

Phase 2

Conditions

Benign Masseteric Hypertrophy

Interventions

Botulinum toxin type A
Placebos

Countries

Not provided

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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2017Estimated

Primary Completion Date

Oct 2018Estimated

Completion Date

Oct 2018Estimated

First Submitted Date

Nov 26, 2017

First Submission Date that Met QC Criteria

Dec 11, 2017

First Posted Date

Dec 12, 2017Actual

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

Dec 11, 2017

Last Update Posted Date

Dec 12, 2017Actual

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 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

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Botulinum toxin type A	Experimental	DWP450	Drug: Botulinum toxin type A
Placebo	Placebo Comparator	Normal Saline	Drug: Placebos

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin type A	Drug	Botulinum toxin type A(DWP450)	Botulinum toxin type A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Reduction amount of masseter muscle thickness	Reduction amount of masseter muscle thickness by Ultrasonography	At 4,8,16 weeks
Reduction amount of lower face volume	Reduction amount of 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 treatment, including double jaw surgery, laser, thread treatment etc. in 12 months.
Subject who had previously received botulinum toxin within 3 months 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

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided