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

Sponsor

Dongkook Pharmaceutical Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT06021418

Collaborator

(none)

100

Enrollment

Location

Arms

35.9

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Crow's Feet	Device: DKB-119	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 2, 2020

Anticipated Primary Completion Date :

Sep 8, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DKB-119 Injecting to one side crow's feet	Device: DKB-119 Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.
Active Comparator: Control Injecting to one side crow's feet	Device: DKB-119 Experimental and Acitve Comparator are applied 4 times to each of crow's feet on both sides of the subject.

Arm

Intervention/Treatment

Experimental: DKB-119

Injecting to one side crow's feet

Device: DKB-119

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

Active Comparator: Control

Injecting to one side crow's feet

Device: DKB-119

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

Outcome Measures

Primary Outcome Measures

Crow's feet [18 weeks]
Difference in improvement rate (%)

Secondary Outcome Measures

Crow's feet [8, 10 weeks]
Difference in improvement rate (%)
LCL Severity [8, 10, 18 weeks]
Difference in improvement rate (%)
GAIS [8, 10, 18 weeks]
GAIS 5 point scale (-1 to 3 points)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungang-University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Dongkook Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dongkook Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT06021418

Other Study ID Numbers:

DKB-119-MD-2

First Posted:

Sep 1, 2023

Last Update Posted:

Sep 1, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 1, 2023