| CTRI Number |
CTRI/2024/09/074297 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Botulinum Toxin A for dynamic Upper face rhytides |
|
Scientific Title of Study
|
A Pilot study comparing needle Electromyographic guidance vs. conventional blind method of injecting Botulinum Toxin A for treating upper face dynamic rhytides |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Badamutlang Dympep |
| Designation |
Assistant Professor Burns and Plastic Surgery |
| Affiliation |
NEIGRIHMS |
| Address |
Room no.24, Ground floor.
Dept. of Burns and Plastic Surgery
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Hospital
MAWDIANGDIANG
SHILLONG
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
8575490028 |
| Fax |
|
| Email |
badadympep@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Badamutlang Dympep |
| Designation |
Assistant Professor Burns and Plastic Surgery |
| Affiliation |
NEIGRIHMS |
| Address |
Room no. 24, Ground floor
Dept. of Burns & Plastic Surgery
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Hospital
MAWDIANGDIANG
SHILLONG
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
8575490028 |
| Fax |
|
| Email |
badadympep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Badamutlang Dympep |
| Designation |
Assistant Professor Burns and Plastic Surgery |
| Affiliation |
NEIGRIHMS |
| Address |
Room no. 24, Ground floor
Dept. of Burns & Plastic Surgery
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Hospital
MAWDIANGDIANG
SHILLONG
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
8575490028 |
| Fax |
|
| Email |
badadympep@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Grant Committee
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences
Mawdiangdiang, Shillong- 793018
Meghalaya, India |
|
|
Primary Sponsor
|
| Name |
NEIGRIHMS Hospital Shillong |
| Address |
Intramural Research Grant Committee North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang, Shillong- 793018 Meghalaya, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrBadamutlang Dympep |
NEIGRIHMS Hospital |
ROOM 24, Ground Floor
Dept. Of Burns and Plastic Surgery
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences Mawdiangdiang, Shillong- 793018 Meghalaya, India
East Khasi Hills
MEGHALAYA |
8575490028
badadympep@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Neigrihms Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Blind method of injecting Botulinim Toxin |
The subjects in 1st arm will undergo a Single session (30 minutes) of Botulinum toxin injection by the Conventional blind method for upper face wrinkles.
The Surface EMG will evaluate them at 2 weeks, 3 months and 6 months for any remnant muscle activity of the upper face. This will measure the effectiveness of the Botulinum toxin injection.
|
| Intervention |
Needle Electromyographic Guidance of Botulinum toxin injection |
The subjects will undergo a Single session (30 minutes) of Botulinum Toxin injection for upper face dynamic wrinkles guided by Needle EMG device.
The Surface EMG will evaluate them at 2 weeks, 3 months and 6 months for any remnant muscle activity of the upper face. This will measure the effectiveness of the Botulinum toxin injection. |
|
|
Inclusion Criteria
|
| Age From |
26.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Upper face wrinkles who want correction
2. Subjects with dominant glabellar lines with an angry facial expression even in a relaxed state. These subjects want to eliminate the angry facial expression |
|
| ExclusionCriteria |
| Details |
1. Co-morbidities like hypertension, diabetes mellitus, collagen vascular disorders and autoimmune disorders.
2. Subjects with muscular dystrophy syndrome
3. Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Dermatology Life Quality Index Score System.
2. EMG Readings to look for the efficacy of the Botulinum toxin:
A) RMS : Root Mean square of bin of contraction, with 100ms envelope window
B) MVIC: Maximum voluntary isometric contraction
C) SNR:Signal to Noise ratio
D) Integral absolute value : Time domain assessement
E) MDF:Median power frequency
F) Inertial measurement: Accelerometer, Gyrometer. |
baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The complications are noted in the subjects undergoing these procedures.
The compications are ptosis of the eyelid or eyebrow, eyebrow asymmetry, diplopia, lagophthalmos, palpebral ectropion, & prominence of the palpebral bags. |
At 2 weeks, 3 months & 6 months following the procedure. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Pilot RCT compares 2 methods of injecting Botulinum Toxin A for treating upper face dynamic wrinkles.In this study, 1 arm will undergo BoT A injection by the conventional blind method. The second arm will undergo BoTA injection with Needle EMG guidance.
We will record the Efficacy and complications in these 2 groups of patients and compare the results. |