Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines
- Registration Number
- NCT05428930
- Lead Sponsor
- CKD Bio Corporation
- Brief Summary
A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501B in Glabellar lines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)
Exclusion Criteria
- Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
- History of facial nerve paralysis or ptosis
- Significant facial asymmetry
- Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
- Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
- Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CKDB-501B CKDB-501B - Botox® 50U Botox®50U -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events [Time Frame: up to week 12] Severity and frequency of reported adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of