DWP450 for Treating Moderate to Severe Glabellar Lines | NCT06354127

Studies
DWP450 for Treating Moderate to Severe Glabellar Lines

NCT06354127

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Apr 9, 2024Actual

Enrollment

473Actual

Phase

Phase 3

Conditions

Moderate to Severe Glabellar Lines

Interventions

DWP450
Botox®

Countries

China

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

Apr 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

Aug 12, 2020Actual

Primary Completion Date

Nov 24, 2020Actual

Completion Date

Jan 25, 2021Actual

First Submitted Date

Apr 3, 2024

First Submission Date that Met QC Criteria

Apr 3, 2024

First Posted Date

Apr 9, 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 9, 2024Actual

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

A multi-center, randomized, double-blind, positive drug-controlled clinical study to evaluate the safety and efficacy of Botulinum Toxin Type A for Injection in the treatment of 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

473Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DWP450	Experimental		Drug: DWP450
Botox®	Active Comparator		Drug: Botox®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DWP450	Drug	The test drug or control drug is injected on the day of administration.	DWP450

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response rate based on the investigator's on-site assessment of severity of glabellar lines at maximum frown	The difference between the two groups in response rate at Week 4 based on the investigator's on-site assessment of severity of glabellar lines (at maximum frown).	Week 4

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult males or females aged 20-65 years old.
Moderate to severe (grade 2-3) glabellar lines based on investigator's assessment of severity of glabellar lines at maximum frown.

Exclusion Criteria:

Having received any glabellar (including forehead) cosmetic procedures/surgeries, such as dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, or dermabrasion within 6 months prior to screening.
Planning to receive any facial cosmetic procedures/surgeries, including but not limited dermal filling, face lifting, photoelectric therapy, hydro lifting, microneedle, chemical peeling or scar removal surgery, during the study period.
Skin infection at injection site or systemic skin disease assessed with the potential to interfere with efficacy evaluation or safety evaluation of glabellar lines or forehead lines.
Glabellar lines that cannot be fully flattened through surgery, by hand or by other methods.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine		Shanghai	Shanghai Municipality		China

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
C586826	DWP450
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