NCT06021418

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 1, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

September 13, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

April 19, 2023

Last Update Submit

September 10, 2023

Conditions

Crow's Feet

Outcome Measures

Primary Outcomes (1)

  • Crow's feet

    Difference in improvement rate (percentage)

    18 weeks

Secondary Outcomes (3)

  • Crow's feet

    8, 10 weeks

  • LCL(Lateral Canthal Line) Severity

    8, 10, 18 weeks

  • GAIS(Global Aesthetic Improvement Scale)

    8, 10, 18 weeks

Study Arms (2)

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

DKB-119DEVICE

Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.

ControlDKB-119

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy and lactating women.
  • Etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungang-University Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
1. Blind: Participant, Outcomes Assessor 2. Un-blind: Investigator(Care Provider)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2023

First Posted

September 1, 2023

Study Start

November 2, 2020

Primary Completion

September 8, 2023

Study Completion

October 31, 2023

Last Updated

September 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)