To study the safety and efficacy of Botulinum toxin A in patients with (crow’s feet) Wrinkles around the outer corner of eyes.
Not Applicable
Completed
- Registration Number
- CTRI/2022/09/045312
- Lead Sponsor
- Gufic Biosciences Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
18 years and above
Both Male and Female
Moderate to severe lateral canthal lines associated with orbicularis oculi activity
Exclusion Criteria
a)Known Hypersensitivity to Botulinum Toxin
b)Subjects with neuromuscular disorders (myasthenia gravis, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, or motor neuropathy)
c)Subjects who used medications that interfere with the neuromuscular function, such as aminoglycoside antibiotics and curare-like agents, within 4 weeks before screening.
d)Subjects with a previous injection of botulinum toxin Type A within 3 months or cosmetic procedures associated with crow’s feet
e)Pregnancy and lactation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the safety and efficacy of Botulinum toxin A on the crow’s feetTimepoint: After 3 months
- Secondary Outcome Measures
Name Time Method The severity of crow’s feet on both sides will be assessed, using a facial wrinkle scale (FWS) with grades of 0 (none), 1 (mild), 2 (moderate), and 3 (severe) at maximum smile and at rest. Day 0, Week 4, Week 8 And Week 12Timepoint: After 3 months