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

Dongkook Pharmaceutical Co., Ltd.100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Crow's Feet

Interventions

DKB-119DEVICE

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chungang-University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Crow's feet

Difference in improvement rate (percentage)

Time frame: 18 weeks

Secondary Outcomes

Crow's feet

Difference in improvement rate (percentage)

Time frame: 8, 10 weeks

LCL(Lateral Canthal Line) Severity

Difference in improvement rate (percentage)

Time frame: 8, 10, 18 weeks

GAIS(Global Aesthetic Improvement Scale)

GAIS 5 point scale (minimum -1 to maximum 3 points, The higher the score, the better the value)

Time frame: 8, 10, 18 weeks

Data from ClinicalTrials.gov

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