| CTRI Number |
CTRI/2025/11/098067 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dermatological procedure] |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing two CO2 laser and steroid injection treatments to improve keloid scars |
|
Scientific Title of Study
|
Evaluating The Efficacy and Safety of CO2 Laser-Assisted Drug Delivery of Pirfenidone Combined with Intralesional Triamcinolone Acetonide (ILTAC) Versus CO2 Laser With ILTAC Alone in Keloid. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CACS-DS (25-26)-006, Version 1, Dated 02 Oct 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:10 Department of Dermatology
5/1, 4th Main, MRCR Layout, Vijayanagar Bangalore KARNATAKA 560040 India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:10 Department of Dermatology
5/1, 4th Main, MRCR Layout, Vijayanagar
KARNATAKA 560040 India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Madura C |
| Designation |
Medical Director and Chief Hair transplant Dermatosurgeon |
| Affiliation |
CUTIS Academy of Cutaneous Sciences |
| Address |
Room No:10 Department of Dermatology
5/1, 4th Main, MRCR Layout, Vijayanagar
KARNATAKA 560040 India |
| Phone |
9632741998 |
| Fax |
|
| Email |
maduradr@gmail.com |
|
|
Source of Monetary or Material Support
|
| CUTIS Academy of Cutaneous Sciences 5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Prateek Nayak |
CUTIS Academy of Cutaneous Sciences |
5/1,4th Main, MRCR Layout, Vijayanagar, Bangalore 560040 Bangalore KARNATAKA |
9561509166
nayakprateek@rocketmail.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 |
| Patients |
(1) ICD-10 Condition: L910||Hypertrophic scar, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fractional co2 laser with ILTAC alone |
Fractional CO2 laser in DEEP FX mode (17.5–22.5 J/cm2, 10 percent density, 300 Hz) followed by intralesional triamcinolone acetonide 20 mg/mL (0.1 mL/cm2) will be given in up to four sessions at 4-week intervals or stopped earlier if 90 percent volume reduction is achieved. |
| Intervention |
Fractional CO2 laser–assisted delivery of 8 percent pirfenidone gel combined with intralesional triamcinolone acetonide. |
Fractional CO2 laser treatment will be performed in DEEP FX mode with energy 17.5 to 22.5 J/cm2, density 10 percent, and frequency 300 Hz, followed by intralesional triamcinolone acetonide 20 mg/mL, 0.1 mL per cm2 injection. Immediately after laser, 0.5 to 1 g of 8 percent pirfenidone gel will be applied under occlusion for 30 minutes, then continued twice daily at home until the next session. Up to four sessions will be done at 4-week intervals, stopping earlier if 90 percent or more volume reduction occurs. After treatment, pirfenidone application will continue twice daily for 12 weeks as an extended phase. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender aged 15–60 years with clinically diagnosed keloids measuring 2–10 cm in largest diameter, who are treatment-naïve and have stable lesions for at least 6 months, located on the trunk, extremities, or neck. |
|
| ExclusionCriteria |
| Details |
1.Patients with infected keloids or coexisting inflammatory systemic skin diseases
2.Unrealistic expectations or psychiatric illnesses
3.Pre existing bleeding disorders
4.Lactating/pregnant patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare keloid volume change from baseline to end of treatment between CO2 laser-assisted topical pirfenidone gel with ILTAC and CO2 laser with ILTAC alone using Antera 3D volumetric measurements |
After week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in scar texture parameters (roughness and height), hemoglobin and melanin indices measured by Antera 3D, and recurrence monitoring through volumetric and chromophore analysis at follow-up. Additional assessments include clinician-rated Vancouver Scar Scale and POSAS observer scores, patient-reported POSAS, visual analogue scales for itch and pain, and satisfaction Likert scores. Safety endpoints include incidence and severity of corticosteroid-related effects (atrophy, telangiectasia, hypopigmentation, pain) and local pirfenidone reactions (erythema, burning, pruritus), documented throughout treatment and follow-up |
After week 24 |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
15/12/2025 |
| 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
|
Keloids are raised scars that extend beyond the
original wound because of excessive collagen production during healing. Beyond
their appearance, they can cause itching, pain, and restricted movement,
leading to distress, self-consciousness, and a significant reduction in quality
of life and psychological well-being. Standard keloid management often involves
intralesional triamcinolone acetonide injections, which help suppress
fibroblast activity and collagen production. However, recurrences are common, and
repeated injections may cause skin atrophy, telangiectasia, and perilesional
hypopigmentation. Even after satisfactory volume reduction, the overlying skin
surface often remains irregular and cosmetically unsatisfactory. Fractional CO2
laser allows controlled remodeling of scar tissue and may improve texture to
some extent; however, monotherapy remains insufficient for achieving sustained
and comprehensive improvement. Combination approaches are needed to reduce the
adverse effects associated with repeated steroid injections, address the risk
of recurrence, and improve overall treatment outcomes. Pirfenidone, an orally
approved antifibrotic, downregulates TGF beta 1, PDGF, and TNF alpha, thereby
curbing fibroblast proliferation and collagen type I deposition. In keloid
management, early clinical studies have shown promising results with the
topical formulation, eight percent pirfenidone gel, in improving pathological
scars. Combination of fractional CO2 laser with eight percent pirfenidone gel
may modulate the early pro-fibrotic wound phase, promote organized collagen
remodeling, and potentially yield superior outcomes compared with fractional
CO2 laser and triamcinolone acetonide alone. |