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CTRI Number  CTRI/2025/11/097927 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 23/07/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A COMPARATIVE STUDY ON EFFICACY AND SAFETY OF INTRALESIONAL INSULIN VS INTRALESIONAL TRIAMCINOLNE ACETONIDE VS INTRALESIONAL TRIAMCINOLONE ACETONIDE + 5-FLUOROURACIL FOR KELOID. 
Scientific Title of Study   A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY ON EFFICACY AND SAFETY OF INTRALESIONAL INSULIN VS INTRALESIONAL TRIAMCINOLNE ACETONIDE VS INTRALESIONAL TRIAMCINOLONE ACETONIDE + 5-FLUOROURACIL FOR KELOID. 
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 Jashanpreet Kaur 
Designation  Junior Resident 
Affiliation  Shri Bhausaheb Hire Government Medical College 
Address  OPD No.18,Department of Dermatology ,Shri Bhausaheb Hire Government Medical College, Surat Bypass Chakkarbardi,Dhule,Maharashtra-424001

Dhule
MAHARASHTRA
424001
India 
Phone  8360860225  
Fax    
Email  jashansandhu083@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chetan Rajput 
Designation  Professor and Head of Department 
Affiliation  Shri Bhausaheb Hire Government Medical College 
Address  OPD No.18, Department of Dermatology, Shri Bhausaheb Hire Government Medical College, Surat Bypass Chakkarbardi,Dhule,Maharashtra-424001

Dhule
MAHARASHTRA
424001
India 
Phone  8888487808  
Fax    
Email  drchetanrajput@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Jashanpreet Kaur 
Designation  Junior Resident 
Affiliation  Shri Bhausaheb Hire Government Medical College 
Address  OPD No.18, Department of Dermatology, Shri Bhausaheb Hire Government Medical College, Surat Bypass Chakkarbardi,Dhule,Maharashtra-424001

Dhule
MAHARASHTRA
424001
India 
Phone  8360860225  
Fax    
Email  jashansandhu083@gmail.com  
 
Source of Monetary or Material Support  
Shri Bhausaheb Hire Government Medical College and Hospital, Dhule 
 
Primary Sponsor  
Name  Dr.Jashanpreet Kaur 
Address  PG Hostel,Shree Bhausaheb Hire Medical College,Surat Bypass Chakkarbardi,Dhule,Maharashtra-424001 
Type of Sponsor  Other [Self] 
 
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 
DrJashanpreet Kaur  Shri Bhausaheb Hire Government Medical College and Hospital, Dhule  OPD No.18,Department of Dermatology, Venereology, Leprology, Shri Bhausaheb Hire Government Medical College and Hospital, Dhule, Maharashtra
Dhule
MAHARASHTRA 		 8360860225

jashansandhu083@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,SBHGMC,Dhule  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 
Intervention  Intralesional Injection Insulin   Patients will be given intralesional short acting insulin at a dose of 10 IU/cm3 at an interval of 4 weeks for 4 months 
Comparator Agent  Intralesional Injection Triamcinolone Acetonide  Patients will be given intralesional Injection Triamcinolone Acetonide 40 mg/mL diluted to 20 mg/Ml using local anaesthetic and administered at a dose of 0.1 mL/cm3, at an interval of 4 weeks for 4 months. 
Comparator Agent  Intralesional Injection Triamcinolone Acetonide + 5-Fluorouracil  Patients will be given intralesional injection of 50 mg/mL 5-Fluorouracil + 40 mg/mL Triamcinolone acetonide in ratio of 9:1 at a dose of 0.1 mL/cm3 , at an interval of 4 weeks for 4 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •Age 18 to 60 years
•Both male and female
•Clinical diagnosis of keloid equal to more than 3 months duration
•Keloid of size between 1 to 10 cubic centimeters.
•Willing to provide informed consent and comply with follow-up


 
 
ExclusionCriteria 
Details  -Age less than 18 or more than 60 years
-Keloid of size more than 10 cubic centimeters.
-Diabetic patients
-Individuals receiving insulin or oral hypoglycemic drugs
-Pregnant or lactating female
-Immunocompromised patients
-Patients on immunosuppressive drugs or systemic corticosteroids within last 3 months
-Patients with evidence of bone marrow suppression including leukopenia,thrombocytopenia or anemia
-Active infection or ulceration over lesion
-Recent keloid treatment within last 8 weeks
-Keloids on mucosa, eyelids or sites unsafe for injection
-Coagulopathy or bleeding disorder
-Hypersensitivity to study drugs
-Individuals unwilling or unable to comply with the follow up schedule 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the clinical efficacy of Intralesional Insulin vs Intralesional Triamcinolone acetonide vs Intralesional Triamcinolone acetonide + 5-Fluorouracil in management of keloid.  Baseline, 4, 8, 12 and 16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To study safety and tolerability of Intralesional Insulin vs Intralesional Triamcinolone Acetonide vs Intralesional Triamcinolone Acetonide + 5- Fluorouracil in management of keloid.

 		 7 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 4 
Date of First Enrollment (India)   02/12/2025 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) - 

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 20-11-2025 and end date provided 20-11-2028?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Keloids are benign fibroproliferative growths of dermal connective tissue that arises from a disorganized fibro-proliferative collagen response that extends beyond the original wound margins due to excessive production of extracellular matrix. Clinically, they present with raised, firm, erythematous scars extending beyond the original wound margin, causing functional impairment, disfigurement, pain, and pruritus. Current treatment modalities—intralesional corticosteroids, 5-FU, cryotherapy, lasers, and surgical excision—have variable efficacy and high recurrence rates. This is a prospective, comparative, randomized study on efficacy, safety and tolerability of Intralesional Insulin vs Intralesional Triamcinolone Acetonide vs Intralesional Triamcinolone Acetonide + 5- Fluorouracil for keloid. The study will be conducted at a tertiary care hospital. The patients will be divided in groups of 3 by simple randomization. Each group will have 22 patients each. Group A will include patients who will be given intralesional short acting insulin at a dose of 10 IU/cm3 at an interval of 4 weeks for 4 months. Group B will include patients who will be given intralesional Injection Triamcinolone Acetonide 40 mg/mL diluted to 20 mg/ml using local anaesthetic and administered at a dose of 0.1 mL/cm3, at an interval of 4 weeks for 4 months. Group C will include patients who will be given intralesional injection of 50 mg/mL 5-Fluorouracil + 40 mg/mL Triamcinolone acetonide in ratio of 9:1 at a dose of 0.1 mL/cm3 , at an interval of 4 weeks for 4 months. After completion of last visit, the patients will be observed for 3 months period to assess progress, recurrence or any long-term side effects of treatment given. Thus, the study aims to study the efficacy, safety and tolerability of Intralesional Insulin vs Intralesional Triamcinolone Acetonide vs Intralesional Triamcinolone Acetonide + 5- Fluorouracil for keloid. 
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