Crow's Feet Lines
Conditions
Brief summary
To determine the efficacy and safety of Botulax® in treatment of crow's feet line
Detailed description
1. Allocation: Randomized 2. Masking: Double Blind
Interventions
DRUGBotulinum toxin type A
Experimental
Sponsors
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female of at least 19 to 65 years old * Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator
Exclusion criteria
* Subject with hypersensitivity to the investigational products or their components * Female subject who are pregnant or lactating * Subject who are unable to communicate or follow the instructions * Subject who are not eligible for this study based on the judgment of an investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators | 4weeks | The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported as assessed by investigators |
Countries
South Korea
Outcome results
None listed