MEDITOXIN® in Treatment of Crow's Feet Line

March 25, 2019 updated by: Medy-Tox

A Randomized, Double-blind, Active Drug Controlled, Multi-center, Phase Ⅰ/Ⅲ Study to Determine the Efficacy and Safety of Meditoxin® in Treatment of Crow's Feet Line

to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female of at least 20 to 65 years old
  • Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria:

  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
  • Patients with allergy or hypersensitivity to the investigational drugs or their components
  • Patients who have bleeding tendency or taking anti-coagulant
  • Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
  • Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
  • Patients who are unable to communicate or follow the instructions
  • Patients who are not eligible for this study based on the judgment of an investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MEDITOXIN
Drug: botulinum toxin type A
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
Other Names:
  • BOTOX
Active Comparator: BOTOX
Drug: botulinum toxin type A
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
Other Names:
  • BOTOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale(FWS)
Time Frame: 4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medy-Tox

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

May 14, 2018

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 18, 2017

First Posted (Actual)

October 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT01-KR17CFL903

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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