Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408236
• Other study ID #: HG-BOTCFL-III1
• Status: Completed
• Phase: Phase 3
• Start date: January 17, 2018
• Est. completion date: June 7, 2019

Study information

• Verified date: April 2022
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the efficacy and safety of Botulax® in treatment of crow's feet line

Description:

1. Allocation: Randomized

2. Masking: Double Blind

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Crow's Feet Lines

Intervention

Drug:
• Botulinum toxin type A
Experimental
• Botulinum toxin type A
Active Comparator

Locations

Country	Name	City	State
Korea, Republic of	Hugel	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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