MEDITOXIN® in Treatment of Crow's Feet Line

Crow's Feet Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317574
• Other study ID #: MT01-KR17CFL903
• Status: Completed
• Phase: Phase 3
• Start date: August 17, 2017
• Est. completion date: May 14, 2018

Study information

• Verified date: March 2019
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 14, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crow's Feet Lines

Intervention

Drug:
• botulinum toxin type A
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
• botulinum toxin type A
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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