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

September 10, 2023 updated by: Dongkook Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongkook Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Estimated)

September 8, 2023

Study Completion (Estimated)

October 31, 2023

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DKB-119-MD-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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