| 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
|
|
|
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
|
|
|
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.
|