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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03408236
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Hugel

Study Description
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Brief Summary:
To determine the efficacy and safety of Botulax® in treatment of crow's feet line

Condition or disease Intervention/treatment Phase
Crow's Feet Lines Drug: Botulinum toxin type A Phase 3

Detailed Description:
  1. Allocation: Randomized
  2. Masking: Double Blind
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Foot Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: Botulax
Single dose
 Drug: Botulinum toxin type A
Experimental
Other Name: Botulax
Active Comparator: Botox
Single dose
 Drug: Botulinum toxin type A
Active Comparator
Other Name: Botox


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408236


Locations
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Korea, Republic of
Hugel
Seoul, Korea, Republic of
Sponsors and Collaborators
Hugel
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hugel
ClinicalTrials.gov Identifier: NCT03408236    
Other Study ID Numbers: HG-BOTCFL-III1
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents