Crow's Feet Lines Clinical Trial
Official title:
Randomized, Double-blind, Active-controlled, Multicenter, Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
Verified date | April 2022 |
Source | Hugel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the efficacy and safety of Botulax® in treatment of crow's feet line
Status | Completed |
Enrollment | 240 |
Est. completion date | June 7, 2019 |
Est. primary completion date | December 13, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hugel | Seoul |
Lead Sponsor | Collaborator |
---|---|
Hugel |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators | 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 | 4weeks |
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