| CTRI Number |
CTRI/2022/09/045312 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the safety and efficacy of Botulinum toxin A in patients with (crow’s feet) Wrinkles around the outer corner of eyes. |
|
Scientific Title of Study
|
Comparison of safety and efficacy of 2 brands of Botulinum Toxin A for the treatment of crow’s feet: A Split face study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS-GBL-002, Version:01, 26 July 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaithra Shenoy |
| Designation |
Lead Aesthetic Dermatologist & Consultant Dermatologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Dept. of Aesthetic Dermatology
Room No:7
5/1,4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA
560040
India |
| Phone |
|
| Fax |
|
| Email |
chaithrashenoy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Agrawal |
| Designation |
Consultant Dermatologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
5/1,4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA
560040
India |
| Phone |
|
| Fax |
|
| Email |
rituagrawal25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Agrawal |
| Designation |
Consultant Dermatologist |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
5/1,4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA
560040
India |
| Phone |
|
| Fax |
|
| Email |
rituagrawal25@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciens 5/1,4th Main, MRCR layout, Vijayanagar, bangalore
560040 |
|
|
Primary Sponsor
|
| Name |
Gufic Biosciences Ltd |
| Address |
1st to 4th Floor, S.M. HOUSE, 11, SAHAKAR ROAD, VILE PARLE
EAST, Mumbai, Maharashtra, 400057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritu Agrawal |
CUTIS Academy of Cutaneous Sciences |
Deparment of Dermatology
1st floor, Room No:9
5/1,4th Main, MRCR Layout, Vijayanagar
Bangalore
KARNATAKA |
9460438940
rituagrawal25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CUTIS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
crow’s feet |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Botulinum toxin A Indian Brand (STUNNOX) |
Reconstituted toxin injected 3 sites on one site (3-4 units at each site) |
| Comparator Agent |
Botulinum toxin A International Brand |
Reconstituted toxin injected 3 sites on other site (3-4 units at each site) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
18 years and above
Both Male and Female
Moderate to severe lateral canthal lines associated with orbicularis oculi activity |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the safety and efficacy of Botulinum toxin A on the crow’s feet |
After 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 12 |
After 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/09/2022 |
| Date of Study Completion (India) |
20/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/03/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Facial
wrinkles are classified as dynamic wrinkles that occur with facial expression
and static wrinkles that appear at rest. Static wrinkles are caused by
cutaneous sagging or a decrease in the subcutaneous fat layer and atrophy of
the dermis1. Dynamic wrinkles, caused by repeated muscular
contraction, can be improved with botulinum toxin injection.
Crow’s feet, are horizontal lines in the
lateral canthal area that appear when smiling. Crow’s feet are predominantly
associated with the action of the lateral orbicularis oculi muscle and
partially with that of the zygomaticus muscle.2
Botulinum toxin injection is the most
commonly performed nonsurgical procedure worldwide.3 |