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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05804656
Other study ID # CKDB-BAGL-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 13, 2023
Est. completion date November 20, 2023

Study information

Verified date December 2023
Source CKD Bio Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date November 20, 2023
Est. primary completion date August 29, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
CKDB-501A
Intramuscular injection CKDB-501A
Botox®
Intramuscular injection Botox®

Locations

Country Name City State
Korea, Republic of Chung-Ang University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
CKD Bio Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
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