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

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

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 Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Drug: CKDB-501A; Drug: Botox®

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CKDB-501A	Drug: CKDB-501A; Intramuscular injection CKDB-501A
Active Comparator: Botox®	Drug: Botox®; Intramuscular injection Botox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Week 4

Collaborators and Investigators

• Sponsor: CKD Bio Corporation
• Investigators: Principal Investigator: Beomjoon Kim, Chung-Ang University Hosptial

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2023
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CKDB-BAGL-301

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