Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial
- Registration Number
- NCT05804656
- Lead Sponsor
- CKD Bio Corporation
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botox® Botox® - CKDB-501A CKDB-501A -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of