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
1 other identifier
interventional
300
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2023
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
April 7, 2023
CompletedStudy Start
First participant enrolled
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2023
CompletedDecember 12, 2023
December 1, 2023
5 months
March 27, 2023
December 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
CKDB-501A
EXPERIMENTALBotox®
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- Any medical condition that can affect the neuromuscular function
- History of facial nerve paralysis or ptosis
- Significant facial asymmetry
- Subjects whose glabellar lines cannot be sufficiently improved by physical method
- Subjects who have a previous surgical history that could result in any anatomical changes related to corrugator muscle, procerus muscle, or any relevant nerves
- Subjects with skin abnormalities at potential injection sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung-Ang University Hospital
Seoul, South Korea
Related Publications (1)
Choi SY, Kim BJ, Lee YW, Kim WS, Yoon YN, Kim JS. Efficacy and Safety of CKDB-501A in Treating Moderate-To-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center Phase III Trial. J Cosmet Dermatol. 2025 Jul;24(7):e70305. doi: 10.1111/jocd.70305.
PMID: 40586136DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beomjoon Kim
Chung-Ang University Hosptial
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 7, 2023
Study Start
April 13, 2023
Primary Completion
August 29, 2023
Study Completion
November 20, 2023
Last Updated
December 12, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share