| CTRI Number |
CTRI/2025/10/095881 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare and find the better option for treatment of keloids between laser with injection or injection alone. |
|
Scientific Title of Study
|
An interventional prospective study to evaluate and compare the efficacy of the combination of Fractional CO2 Laser (FCL) and Intralesional Triple therapy (ILS-3) against Intralesional Triple Therapy (ILS-3) alone in the treatment of keloids. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chetan Turale |
| Designation |
Post graduate student |
| Affiliation |
Dr Vithalrao Vikhe Patil Foundations hospital Ahmadnagar |
| Address |
Out patient department number 106 Department of dermatology venereology and leprosy basement division
Dr Vithalrao Vikhe Patil foundations hospital Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8805832318 |
| Fax |
|
| Email |
drchetan1508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mithila Gadekar |
| Designation |
Head of Department |
| Affiliation |
Dr Vithalrao Vikhe Patil Foundations hospital Ahmadnagar |
| Address |
Out patient department number 106 Department of dermatology venereology and leprosy basement division Dr VIthalrao Vikhe patil Foundations Hospital Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9654248977 |
| Fax |
|
| Email |
ishavanarase@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Turale |
| Designation |
Post graduate student |
| Affiliation |
Dr Vithalrao Vikhe Patil Foundations hospital Ahmadnagar |
| Address |
out patient department number 106 Department of dermatology venerology and leprosy basement division
Dr Vithalrao Vikhe Patil Foundations Hospital Ahmadnagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8805832318 |
| Fax |
|
| Email |
drchetan1508@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Vithalrao Vikhe Patil Foundations Medical College and Hospital Ahmadnagar 414111 |
|
|
Primary Sponsor
|
| Name |
Dr Chetan Turale |
| Address |
Room no 6216 Hostel no 6 Dr Vithalrao Vikhe Patil Foundations Medical College and Hospital Ahmadnagar 414111 |
| Type of Sponsor |
Other [self] |
|
|
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 Chetan Turale |
Dr Vithalrao VIkhe Patil Foundations Hospital |
Out patient department number 106 department of Dermatology Venereology and Leprosy Basement division
Near Governement Milk Dairy Vilad Ghat Ahmadnagar 414111
Ahmadnagar
MAHARASHTRA |
8805832318
drchetan1508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L910||Hypertrophic scar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fractional CO2 Laser with Intralesional triple combination injection |
Depending on site energy and density of CO2 laser shall be applied.
10 min following laser therapy
Intralesional triple combination injection consisting of the following dose- inj triamcinolone acetonide in concentration of 40mg per ml per vial of which o.4ml to be taken
Inj 5 fluorouracil in concentration of 500mg per 10 ml per ampoule of which 0.6 ml to be taken
these together injected into a vial containing Inj Hyaluronidase 1500 units
the vial with the three agents incorporated will be shaken vigorously in order to assure adequate mixing and injected 1ml in keloid with a tuberculin syringe.
these doses are to be repeated every 3 weekly for 4 sessions.
route of administration: intralesional
total duration: 12 weeks |
| Comparator Agent |
Intralesional triple combination injection alone |
Intralesional triple combination injection consisting of the following dose- inj triamcinolone acetonide in concentration of 40mg per ml per vial of which o.4ml to be taken Inj 5 fluorouracil in concentration of 500mg per 10 ml per ampoule of which 0.6 ml to be taken these together injected into a vial containing Inj Hyaluronidase 1500 units the vial with the three agents incorporated will be shaken vigorously in order to assure adequate mixing and injected 1ml in keloid with a tuberculin syringe. these doses are to be repeated every 3 weekly for 4 sessions. route of administration: intralesional total duration: 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of keloids more than 18 years of age
Patients who have given informed consent |
|
| ExclusionCriteria |
| Details |
Patients not consenting to be a part of the study
Paediatric and geriatric patients
Pregnant or lactating cases
Cases with obvious signs of infection over the keloid or any sign of malignancy
Patient with a history of any past treatment for keloids |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regression in the dimensions of keloid |
Every 3 weekly for 4 sessions then at 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regression in the associated symptoms viz pain and pruritus |
after 2 sessions |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
01/11/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drchetan1508@gmail.com].
- For how long will this data be available start date provided 16-09-2027 and end date provided 16-09-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, open lable, parallel group, single centre trial evaluating and comparing the efficacy of the combination of Fractional CO2 Laser and Intralesional triple therapy against Intralesional triple therapy alone in the treatment of keloids. the primary outcome measures regression in the size of keloids every 3 weeks for first 4 sessions, followed by at 3rd and 6th month. the secondary outcome measures the regression in the symptoms associated with keloids viz. pain and pruritus from the second session.
|