Glabellar Lines
Conditions
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
Sponsors
CKD Bio Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed