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

Hugel

Status and phase: Completed; Phase 3

Conditions: Crow's Feet Lines

Treatments: Drug: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03408236

HG-BOTCFL-III1

Details and patient eligibility

About

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

Full description

1. Allocation: Randomized
2. Masking: Double Blind

Enrollment: 240 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Botulax

Experimental group

Description:

Single dose

Treatment:

Drug: Botulinum toxin type A

Drug: Botulinum toxin type A

Botox

Active Comparator group

Description:

Single dose

Treatment:

Drug: Botulinum toxin type A

Drug: Botulinum toxin type A