MEDITOXIN® in Treatment of Crow's Feet Line

NCT03317574 | Completed Phase 3

• 1 other identifier: MT01-KR17CFL903
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Crow's Feet Lines

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

MEDITOXIN

EXPERIMENTAL

Drug: botulinum toxin type A

BOTOX

ACTIVE COMPARATOR

Drug: botulinum toxin type A

Interventions

botulinum toxin type A DRUG

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

Also known as: MEDITOXIN

MEDITOXIN

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: October 23, 2017
• Study Start: August 17, 2017
• Primary Completion: December 1, 2017
• Study Completion: May 14, 2018
• Last Updated: March 27, 2019

Record last verified: 2019-03

Locations

KR (1)