Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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 : Unknown
Verified November 2017 by Hugel.
Recruitment status was:  Recruiting
First Posted : January 23, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Hugel

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 11, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Foot Health

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




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



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.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Jin Hong Park, General Manager 82-2-6966-1651 jhpark@hugel.co.kr

Locations
Layout table for location information
Korea, Republic of
Hugel Recruiting
Seoul, Korea, Republic of
Contact: Korea         
Sponsors and Collaborators
Hugel

Layout table for additonal information
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: January 26, 2018
Last Verified: November 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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