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OpenTrials
Completed

NCT Number: NCT03408236

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

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

Completed

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Key information

Conditions

Crow's Feet Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hugel

Seoul, South Korea

About this study

  • Allocation: Randomized
  • Masking: Double Blind

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Experimental

Other names: Botulax

Primary outcomes

  1. Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 23, 2018
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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