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

A Single Center, Randomized, Subject and Evaluator Blinded, Split-face, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of DKB-119 in Crow's Feet

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06021418

Enrollment

100

Registered

2023-09-01

Start date

2020-11-02

Completion date

2023-10-31

Last updated

2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crow's Feet

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

Interventions

DEVICEDKB-119

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

1. Blind: Participant, Outcomes Assessor 2. Un-blind: Investigator(Care Provider)

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Crow's feet	8, 10 weeks	Difference in improvement rate (percentage)
LCL(Lateral Canthal Line) Severity	8, 10, 18 weeks	Difference in improvement rate (percentage)
GAIS(Global Aesthetic Improvement Scale)	8, 10, 18 weeks	GAIS 5 point scale (minimum -1 to maximum 3 points, The higher the score, the better the value)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026