Efficacy and Safety of DKB-119 in Patients in Crow's Feet | NCT06021418

Studies
Efficacy and Safety of DKB-119 in Patients in Crow's Feet

NCT06021418

Sponsor

Dongkook Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 13, 2023Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Crow's Feet

Interventions

DKB-119

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

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2, 2020Actual

Primary Completion Date

Sep 8, 2023Estimated

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Apr 19, 2023

First Submission Date that Met QC Criteria

Aug 28, 2023

First Posted Date

Sep 1, 2023Actual

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

Sep 10, 2023

Last Update Posted Date

Sep 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 prove the non-inferiority of DKB-119 by evaluating the injecting efficacy and safety DKB-119 and control for patients in crow's feet

Detailed Description

A single center, randomized, subject and evaluator blinded, split-face, pivotal clinical trial

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DKB-119	Experimental	Injecting to one side crow's feet	Device: DKB-119
Control	Active Comparator	Injecting to one side crow's feet	Device: DKB-119

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DKB-119	Device	Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.	Control DKB-119

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Crow's feet	Difference in improvement rate (percentage)	18 weeks

Secondary Outcomes

Measure	Description	Time Frame
Crow's feet	Difference in improvement rate (percentage)	8, 10 weeks
LCL(Lateral Canthal Line) Severity	Difference in improvement rate (percentage)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those who are over 19 under 70 ages.
Those who score 2 or more in the LCL severity evaluation.
Those who have visually symmetrical crow's feet on both sides.
Etc.

Exclusion Criteria:

Pregnancy and lactating women.
Etc.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

70 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
Chungang-University Hospital		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