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

NCT ID: NCT06021418

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2023-10-31

Brief Summary

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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

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

Conditions

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Crow's Feet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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DKB-119

Injecting to one side crow's feet

Group Type EXPERIMENTAL

DKB-119

Intervention Type DEVICE

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

Control

Injecting to one side crow's feet

Group Type ACTIVE_COMPARATOR

DKB-119

Intervention Type DEVICE

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

Interventions

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DKB-119

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongkook Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungang-University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DKB-119-MD-2

Identifier Type: -

Identifier Source: org_study_id

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