Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
- Registration Number
- NCT03408236
- Lead Sponsor
- Hugel
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Botulax Botulinum toxin type A Single dose Botox Botulinum toxin type A Single dose
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hugel
🇰🇷Seoul, Korea, Republic of