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CTRI Number  CTRI/2025/08/093083 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Topical Pirfenidone Gel and Intralesional Triamcinolone acetonide injections ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effectiveness of pirfenidone gel with injectable steroid therapy in keloids 
Scientific Title of Study   A comparative study between intralesional steroid and topical pirfenidone gel vs intralesional steroid monotherapy in the management of keloids : an open label randomised controlled trial in a tertiary care hospital in Eastern India  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenakshi Khemka 
Designation  Post graduate resident 
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata  
Address  Dermatology Department IPGMER and SSKM Hospital 244 AJC Bose Road

Kolkata
WEST BENGAL
700020
India 
Phone  7980224023  
Fax    
Email  drmeenakshikhemka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subhamoy Neogi 
Designation  RMO and Clinical Tutor  
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata  
Address  Dermatology Department IPGMER and SSKM Hospital 244 AJC Bose Road

Kolkata
WEST BENGAL
700020
India 
Phone  9432848942  
Fax    
Email  neocnmc05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subhamoy Neogi 
Designation  RMO and Clinical Tutor  
Affiliation  Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata  
Address  Dermatology Department IPGMER and SSKM Hospital 244 AJC Bose Road


WEST BENGAL
700020
India 
Phone  9432848942  
Fax    
Email  neocnmc05@gmail.com  
 
Source of Monetary or Material Support  
Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata 
 
Primary Sponsor  
Name  Institute of Post Graduate Medical Education and Research and SSKM Hospital Kolkata 
Address  244 AJC Bose Road Kolkata 700020 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Meenakshi Khemka   Dermatology Department IPGMER and SSKM Hospital Kolkata   Room number 1 Dermatology Department 244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL 
7980224023

drmeenakshikhemka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGMER Research Oversight 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  Intralesional Triamcinolone acetonide at 20 mg per ml strength   Intralesional Triamcinolone acetonide for keloid works as an anti inflammatory agent that also suppresses fibroblast proliferation and excessive collagen production It is a proven gold standard treatment option for keloids Patients with Keloid attending Dermatology OPD of IPGMER Kolkata during the study period meeting the criteria will be identified Written informed consent taken from the patients Data collected regarding medical and personal history, demographics Clinical and photographic records of the keloid with assessment of modified VSS Score at each visit Patients will be randomly allocated into two groups using a computer generated random number table One group shall receive only Intralesional Triamcinolone Acetonide at 20mg per ml strength as required every 3 weeks and the other group shall receive both the Intralesional steroid injection and Pirfenidone 8 percent gel thrice daily assessed every 3 weeks up to 12 weeks for improvement and adverse effects Both groups are assessed every 3 weeks with calculation of modified VSS score along with photographic evidence of response to therapy 
Intervention  Pirfenidone 8 percent gel with Intralesional Triamcinolone acetonide at 20mg per ml strength   Pirfenidone is an anti fibrotic agent that helps in the treatment of keloids by suppressing keloid derived fibroblast contraction by inhibiting TGF beta pathways It is being used as a topical gel formulation in 8 percent strength Patients with Keloid attending Dermatology OPD of IPGMER Kolkata during the study period meeting the criteria will be identified Written informed consent taken from the patients Data collected regarding medical and personal history, demographics Clinical and photographic records of the keloid with assessment of modified VSS Score at each visit Patients will be randomly allocated into two groups using a computer generated random number table One group shall receive only Intralesional Triamcinolone Acetonide at 20mg per ml strength as required every 3 weeks and the other group shall receive both the Intralesional steroid injection and Pirfenidone 8 percent gel thrice daily assessed every 3 weeks up to 12 weeks for improvement and adverse effects Both groups are assessed every 3 weeks with calculation of modified VSS score along with photographic evidence of response to therapy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients attending the Dermatology OPD of IPGMER during the study period ages 18 to 70 years with Keloid scars previously not treated by any other methods will be included with informed consent 
 
ExclusionCriteria 
Details  Pregnant or lactating females, patients with large Keloid scars that are unsuitable for Intralesional Steroid injections, patients treated previously, patients with bleeding disorders, keloids with secondary infection or ulceration unsuitable for intralesional injections, hypersensitivity or drug allergy to Injection Triamcinolone acetonide or topical pirfenidone 8 percent gel, unwilling patients or patients with high treatment expectations 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Patients with keloids shall be randomly allotted into two groups using a computer generated randomised list. One group shall be receiving Intralesional Triamcinolone acetonide and the other group Intralesional triamcinolone with topical Pirfenidone 8 percent gel therapy. The groups will be evaluated before and after treatment based on modified Vancouver Scar Scale. Age group of the selected patients will be 18 years and above.
Modified Vancouver Scar Scale is calculated for keloids based on
Vascularity 0 to 3 points
Pigmentation 0 to 3 points
Pliability 0 to 5 points
Height 0 to 3 points
Pain 0 to 2 points
Pruritus 0 to 2 points
Total maximum score 18 points  
Patients will be assessed as per modified VSS on first visit with photographs followed by 3 weekly up to 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/09/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Hemostasis, inflammation, proliferation and remodelling enable wound healing. Scarring occurs when fibrosis is either reduced or excessive. Keloid fibroblasts continue to produce connective tissue beyond the expected period for normal scars and they do not undergo apoptosis. TGF beta regulates fibroblast proliferation and collagen synthesis. Keloids show over production and inadequate regulation of TGF beta activity.

Pirfenidone is an anti fibrotic anti inflammatory drug that causes suppression of keloid derived fibroblast contraction through inhibition of the TGF beta one pathway, serving as a potential therapeutic agent for keloids.

There are various treatments available using both surgical and non surgical techniques however, optimal results are difficult to predict. Intralesional triamcinolone injections are most commonly used worldwide, however they come with numerous side effects such as pain, skin thinning, subcutaneous tissue atrophy, steroid acne, capillary dilation, development of secondary hypopigmentation and high recurrence rates. 

Often, a combination therapy works more efficiently than monotherapy in keloids. We aim to combine the positive effects of intralesional triamcinolone and pirfenidone 8 percent gel in better management of the condition and asses if this combination might reduce the side effects seen with steroid monotherapy. 


 
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