Glabellar Lines
Conditions
Brief summary
A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Glabellar lines.
Sponsors
CKD Bio Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Intervention model description
Active-controlled
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | up to week 12 | severity and frequency of reported adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with improvement in subject's assessment of glabellar line severity at each follow-up visit | Week 4, 8, 12 | using the Subject Assessment 9-grade Scale(range from -4(very marked worsening) to +4(complete inprovement) |
| Proportion of subjects with improvement in investigator-assessed glabellar line severity at maximum frown at each follow-up visit | Week 4, 8, 12 | using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe)) |
| Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit | Week 4, 8, 12 | using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe)) |
| Changes in the investigator-assessed glabellar line severity score from baseline at each follow-up visit | Week 4, 8, 12 | using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe)) |
| Subject-assessed satisfaction scale at each follow-up visit | Week 4, 8, 12 | using the Subject Satisfaction 7-point Scale(range from 1(very dissatisfied) to 7 (very satisfied) |
Countries
South Korea
Outcome results
None listed