Crow's Feet Lines
Conditions
Brief summary
to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line
Interventions
DRUGbotulinum toxin type A
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
South Korea
Outcome results
None listed