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To study the safety and efficacy of Botulinum toxin A in patients with (crow’s feet) Wrinkles around the outer corner of eyes.

Comparison of safety and efficacy of 2 brands of Botulinum Toxin A for the treatment of crow’s feet: A Split face study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045312
Enrollment
50
Registered
2022-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Botulinum toxin A Indian Brand (STUNNOX): Reconstituted toxin injected 3 sites on one site (3-4 units at each site) Control Intervention1: Botulinum toxin A International Brand: Reconst

Sponsors

Gufic Biosciences Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 18 years and above Both Male and Female Moderate to severe lateral canthal lines associated with orbicularis oculi activity

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To study the safety and efficacy of Botulinum toxin A on the crow’s feetTimepoint: After 3 months—

Secondary

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr Ritu Agrawal

CUTIS Academy of Cutaneous Sciences

rituagrawal25@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026