Status:
COMPLETED
Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines
Lead Sponsor:
CKD Bio Corporation
Conditions:
Glabellar Lines
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05428930
Start Date
June 22 2022
End Date
October 25 2022
Last Update
November 17 2022
Active Locations (1)
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1
Chung-Ang University Hospital
Seoul, South Korea