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

Crow's Feet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06021418
• Other study ID #: DKB-119-MD-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2023
• Source: Dongkook Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 31, 2023
• Est. primary completion date: September 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crow's Feet

Intervention

Device:
• DKB-119
Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.

Locations

Country	Name	City	State
Korea, Republic of	Chungang-University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dongkook Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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