| CTRI Number |
CTRI/2026/04/108943 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF INTRALESIONAL BOTULINUM TOXIN A AND TRIAMCINOLONE ACETONIDE FOR TREATMENT OF HYPERTROPHIC SCARS AND KELOID |
|
Scientific Title of Study
|
COMPARISON OF INTRALESIONAL BOTULINUM TOXIN A AND TRIAMCINOLONE ACETONIDE FOR TREATMENT OF HYPERTROPHIC SCARS AND KELOID-A SPLIT SCAR INTERVENTIONAL RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VAISHNAVI JAISWAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SHRI RAM MURTI SMARAK INSTITUTE OF MEDICAL SCIENCES,Department of dermatology,room no. 103 |
| Address |
491/37,MUNSHIGANJ,DALIGANJ,LUCKNOW
Lucknow
UTTAR PRADESH
226020
India |
| Phone |
7499975667 |
| Fax |
|
| Email |
jaiswal.vaishnavi5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRATIK GAHALAUT |
| Designation |
PROFESSOR |
| Affiliation |
SHRI RAM MURTI SMARAK,INSTITUE OF MEDICAL SCIENCES,DEPARTMENT OF DERMATOLOGY,ROOM 103 |
| Address |
SHRI RAM MURTI SMARAK,INSTITUTE OF MEDICAL SCIENCES
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9319758004 |
| Fax |
|
| Email |
drpratikg@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRATIK GAHALAUT |
| Designation |
PROFESSOR |
| Affiliation |
SHRI RAM MURTI SMARAK,INSTITUE OF MEDICAL SCIENCES,DEPARTMENT OF DERMATOLOGY,ROOM NO. 103 |
| Address |
SHRI RAM MURTI SMARAK,INSTITUTE OF MEDICAL SCIENCES
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9319758004 |
| Fax |
|
| Email |
drpratikg@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SRMS MEDICAL COLLEGE |
| Address |
Shri Ram Murti Institute of Medical Sciences, Bhojipura, Abheypur,Keshonpur,Uttar Pradesh,243202 |
| Type of Sponsor |
Private medical college |
|
|
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 VAISHNAVI JAISWAL |
SHRI RAM MURTI SMARSK INSTITUTE OF MEDICAL SCIENCES |
DERMATOLOGY DEPARTMENT ROOM 101,BHOJIPURA ABHEYPUR KESHONPUR 243202 BAREILLY, UTTAR PRADESH
Bareilly
UTTAR PRADESH |
7499975667
jaiswal.vaishnavi5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Botulinum toxin A |
Use of botulinum toxin A in treatment for hypertrophic scars and keloid will be injected after randomisation of 4-5IU/cm2 every month without exceeding 50IU in one session |
| Comparator Agent |
Intralesional triamcinolone acetonide |
On the basis of randomisation intralesional triamcinolone acetonide in keloid and hypertrophic scars |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All who are willing to give informed written consent |
|
| ExclusionCriteria |
| Details |
Pregnancy
Patients who are breast feeding
Skin lesions or infection at the site
Any neuromuscular disease
Any coagulopathy or is on anticoagulant |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in scar texture,colour,and size across 3 sittings |
Assessment is done at baseline then at every 3 weeks then final assessment at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lack of improvement at 3 weeks |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="6"
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 is a trial to compare the effects of intralesional botulinum toxin A vs conventional intralesional triamcinolone acetonide for the treatment of hypertrophic scars and keloid.The results will be evaluated based on Vancouver scar scale, visual analogue scale and Likert’s scale which will be recorded on each visit.Sittings will be done at an interval of 3 weeks for total 3 sessions. In each session keloid scar will be divided into 2 halves if more than 5 cm if not 2 different sites will be taken and randomisation at 1st sitting will be done via toss a coin method and 1 part will be for intralesional triamcinolone acetonide and other for intralesional botulinum toxin A then at the end of 3 sessions comparison will be done using the scales. |