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

Phase 3CompletedNCT03408236

Hugel240 enrolled

Overview

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

1. Allocation: Randomized 2. Masking: Double Blind

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

240

Conditions

Crow's Feet Lines

Interventions

Botulinum toxin type ADRUG

Experimental

Botulinum toxin type ADRUG

Active Comparator

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hugel

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 4weeks

Data from ClinicalTrials.gov

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