MEDITOXIN® in Treatment of Crow's Feet Line

Medytox

Status and phase: Completed; Phase 3

Conditions: Crow's Feet Lines

Treatments: Drug: botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03317574

MT01-KR17CFL903

Details and patient eligibility

About

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

Enrollment: 250 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups

MEDITOXIN

Experimental group

Treatment:

Drug: botulinum toxin type A

Drug: botulinum toxin type A

BOTOX

Active Comparator group

Treatment:

Drug: botulinum toxin type A

Drug: botulinum toxin type A