Evaluate the Safety and Explore the Efficacy of DWP712 Wi... | NCT06212960

Studies
Evaluate the Safety and Explore the Efficacy of DWP712 With Moderate to Severe Glabellar Lines

NCT06212960

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Apr 4, 2024Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Glabellar Lines

Interventions

DWP712
BOTOX®

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

Jan 2024

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

Nov 28, 2023Actual

Primary Completion Date

Feb 26, 2024Actual

Completion Date

Mar 21, 2024Actual

First Submitted Date

Jan 8, 2024

First Submission Date that Met QC Criteria

Jan 18, 2024

First Posted Date

Jan 19, 2024Actual

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

Apr 3, 2024

Last Update Posted Date

Apr 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

To evaluate the safety of 12-week administration of DWP712 inj. in subjects with moderate to severe glabellar lines.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DWP712	Experimental	Patients were intramuscularly injected (IM) with a total of 20U of DWP712 in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line.	Biological: DWP712
Botox®	Active Comparator	Patients were intramuscularly injected (IM) with a total of 20U of BOTOX® in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line.	Biological: BOTOX®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWP712	Biological	Clostridium botulinum Toxin	DWP712
BOTOX®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of occurrences for grade 3 or higher adverse drug reactions (ADRs) according to CTCAE 5.0		At 4, 8, 12 week after the injection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with facial wrinkle scale (FWS) score of visual appearance of glabellar lines ≥2 (moderate) at maximum frown as assessed by the investigator at screening

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Beom Joon Kim, MD, Ph.D	Chung-Ang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung-Ang University Hosptial		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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