Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial

CKD Bio Corporation300 enrolled

Overview

A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects with Moderated-to-severe Glabella Lines

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Glabellar Lines

Interventions

CKDB-501ADRUG

Intramuscular injection CKDB-501A

Botox®DRUG

Intramuscular injection Botox®

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1\. Subjects with at least moderate glabellar lines at maximum frown as determined by severity score of at least 2-point (moderate) on the Facial Wrinkle Scale (4-point FWS) as assessed by investigator. Exclusion Criteria: 1. Any medical condition that can affect the neuromuscular function 2. History of facial nerve paralysis or ptosis 3. Significant facial asymmetry 4. Subjects whose glabellar lines cannot be sufficiently improved by physical method 5. Subjects who have a previous surgical history that could result in any anatomical changes related to corrugator muscle, procerus muscle, or any relevant nerves 6. Subjects with skin abnormalities at potential injection sites

Locations (1)

Chung-Ang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Proportion of subjects with a ≥ 2-point improvement on the FWS score at maximum frown from baseline, as assessed by the investigator post-administration of the investigational product

Time frame: Week 4

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.