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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  
Name  Address 
NIL   
 
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  
Status 
Not Applicable 
 
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.

 
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