Efficacy and Safety of DWP450 for Treating Crows Feet Lin... | NCT03184363

Studies
Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study)

NCT03184363

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Unknown status

Last Update Posted

Jun 12, 2017Actual

Enrollment

102Estimated

Phase

Phase 3

Conditions

Crow's Feet Lines
Glabellar Lines

Interventions

Clostridium Botulinum A Toxin

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

Jun 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

Jul 2017Estimated

Primary Completion Date

Oct 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jun 8, 2017

First Submission Date that Met QC Criteria

Jun 8, 2017

First Posted Date

Jun 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

Jun 8, 2017

Last Update Posted Date

Jun 12, 2017Actual

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

The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study for CFL.

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

102Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clostridium Botulinum A Toxin	Experimental	Clostridium Botulinum A Toxin	Drug: Clostridium Botulinum A Toxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clostridium Botulinum A Toxin	Drug	Clostridium Botulinum A Toxin	Clostridium Botulinum A Toxin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subject Assessment of Satisfaction of Appearance	Subject Assessment of Satisfaction of Appearance	At 4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female of at least 18 to 75 years old
moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
moderate-to-severe GL at maximum frawn on the FWS as rated by the investigator
Subject who has completed phase 3 study for CFL.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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