| CTRI Number |
CTRI/2025/03/083056 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intense pulsed light and intralesional steroids ] |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare intense pulsed light and intralesional steroids for treating keloids |
|
Scientific Title of Study
|
A study to compare Intense Pulsed Light against its combination with intralesional steroids for the treatment of keloid |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paosh Verma |
| Designation |
Junior resident 1 |
| Affiliation |
Shri ram murti smarak institute of medical sciences |
| Address |
G 122 first floor Saket New Delhi 110017
Shri ram murti smarak institute of medical sciences bhojipura abheypur keshonpur Uttar Pradesh 243202
Bareilly
UTTAR PRADESH
110017
India |
| Phone |
9953605662 |
| Fax |
|
| Email |
paoshverma1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr madhur kant Rastogi |
| Designation |
Professor |
| Affiliation |
Shri ram murti smarak institute of medical sciences |
| Address |
SRMS Bareilly
Shri ram murti smarak institute of medical sciences bhojipura abheypur keshonpur Uttar Pradesh 243202
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
980815847 |
| Fax |
|
| Email |
kantmadhur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Paosh Verma |
| Designation |
Junior resident 1 |
| Affiliation |
Shri ram murti smarak institute of medical sciences |
| Address |
G 122 first floor Saket New Delhi 110017
Shri ram murti smarak institute of medical sciences bhojipura abheypur keshonpur Uttar Pradesh 243202
UTTAR PRADESH
110017
India |
| Phone |
9953605662 |
| Fax |
|
| Email |
paoshverma1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Paosh Verma (Self) |
| Shri ram murti smarak institute of medical sciences Bareilly Uttar Pradesh India 243202 |
|
|
Primary Sponsor
|
| Name |
Srms medical college |
| Address |
Shri ram murti smarak 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 Paosh Verma |
Shri ram murti institute of medical sciences |
Dermatology department room 101 Bhojipura abheypur keshonpur 243202 Bareilly Uttar Pradesh
Bareilly
UTTAR PRADESH |
9953605662
paoshverma1@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: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intense pulsed light |
Use of IPL for treatment of keloid |
| Comparator Agent |
Intense pulsed light with intralesional steroids |
Use of IPL with ILS for treatment of keloid |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All who are willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
Patients not willing to give written informed consent
Patients less than 18 years of age
Pregnancy
Patients who’re breastfeeding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in scar texture colour and size across 3 sittings |
Assessment done at baseline then at 3 weeks followed by final assessment at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lack of improvement at the end of 3 weeks |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| Date of Study Completion (India) |
01/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 intense pulsed light vs its combination with intralesional steroids for the treatment of keloid. The results will be evaluated based on dermatology life quality index, Vancouver scar scale and Detroit scar scale scores which will be recorded on every visit. Sittings will be done at an interval on 3 weeks for a total of 3 sessions. In each patient the keloidal scar will be divided in equal proportions and each approach will be tried on the 2 parts of the scar. At the end of the 3 sessions comparison will be done based on these scales. |