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

Not Applicable

Active, not recruiting

• Conditions: Crow's Feet
• Interventions: Device: DKB-119

• Registration Number: NCT06021418
• Lead Sponsor: Dongkook Pharmaceutical Co., Ltd.

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

Study Timeline

• Study Start: 2020-11-02
• Status Verified: 2023-04
• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-01
• Primary Completion: 2023-09-08
• Last Update Submitted: 2023-09-10
• Last Update Posted: 2023-09-13
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DKB-119	DKB-119	Injecting to one side crow's feet
Control	DKB-119	Injecting to one side crow's feet

Primary Outcome Measures

Name	Time	Method
Crow's feet	18 weeks	Difference in improvement rate (percentage)

Secondary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Chungang-University Hospital; 🇰🇷 Seoul, Korea, Republic of