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CTRI Number  CTRI/2026/01/101243 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Other 
Public Title of Study   A clinical study comparing two modalities for treating keloids: triamcinolone and hyaluronidase injection with and without platelet rich plasma therapy 
Scientific Title of Study   Comparative study of intralesional triamcinolone acetonide injection and hyaluronidase with and without platelet rich plasma therapy in the treatment of keloids 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Brinda K 
Designation  DNB Resident 
Affiliation  Baba Saheb Ambedkar medical college and hospital 
Address  OPD 1003, department of dermatology, Dr Baba saheb ambedkar hospital, rohini west, Delhi 110085.

North West
DELHI
110085
India 
Phone  9080036451  
Fax    
Email  brindavalarmathi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Sagar 
Designation  head of department 
Affiliation  Baba Saheb Ambedkar medical college and hospital 
Address  opd 1003, department of dermatology, Dr Baba Saheb Ambedkar Hospital, rohini west, Delhi 110085.

North West
DELHI
110085
India 
Phone  9080036451  
Fax    
Email  viveksagar_sagar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Brinda K 
Designation  DNB Resident 
Affiliation  Baba Saheb Ambedkar medical college and hospital 
Address  opd 1003, department of dermatology, Dr Baba Saheb Ambedkar hospital, Rohini west, Delhi 110085

North West
DELHI
110085
India 
Phone  9080036451  
Fax    
Email  brindavalarmathi@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Baba saheb ambedkar hospital 
Address  OPD 1003, Department of dermatology,Dr Baba Saheb Ambedkar hospital, Rohini west, Delhi 110085 
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 Brinda K  Dr Baba Saheb Ambedkar medical college and Hospital  opd 1003, department of dermatology, Rohini west, sector 6, Delhi 110085.
North West
DELHI 		 9080036451

brindavalarmathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee of Dr Baba Saheb Ambedkar hospital and medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L918||Other hypertrophic disorders of the skin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intralesional triamcinolone acetonide and hyaluronidase and platelet rich plasma therapy  4 doses of intralesional triamcinolone acetonide and hyaluronidase injection given at 3 weekly interval with platelet rich plasma therapy given at one week after each session of intralesional triamcinolone and hyaluronidase injection for a total of 3 months 
Comparator Agent  intralesional triamcinolone acetonide injection and hyaluronidase   4 doses of intralesional triamcinolone and hyaluronidase injection given three weekly for a total of 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosed cases of localized keloid aged 18-60 years of either gender.
2. Patients with Vancouver scar score greater than or equal to 4.
 
 
ExclusionCriteria 
Details  1. Pregnant or Lactating Women
2. Presence of infection (bacterial, viral, or fungal) at or around the keloid site.
3. History of allergy or hypersensitivity to triamcinolone acetonide, hyaluronidase and components of PRP preparation.
4. Patients with History of bleeding disorders (e.g., hemophilia, thrombocytopenia) and Use of anticoagulants or antiplatelet drugs that cannot be discontinued.
5. Patients with Immunocompromised States Including those with HIV/AIDS, on chemotherapy, or long-term immunosuppressive therapy
6. Prior intralesional steroid, hyaluronidase, PRP injections to the same keloid lesion within the last 3 months.
7. Current or recent (within 1 month) systemic corticosteroid or immunosuppressant therapy.
8. Chronic medical conditions that may affect healing like poorly controlled diabetes mellitus , chronic kidney disease and liver dysfunction or cirrhosis
9. Areas where assessment is difficult (e.g., scalp under thick hair, mucosal surfaces)
10. History of keloid excision in the past 3 months.
11. Patients with widespread keloidosis rather than isolated, well-defined keloid lesions.
12. Ear keloid.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in Vancouver Scar Scale below 4  baseline, 3 weeks, 6 weeks, 9 weeks and 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the efficacy between two groups as per verbal rating scale , patient satisfaction score at 3 weeks 6 weeks 9 weeks 12 weeks  baseline 3 weeks 6 weeks 9 weeks
12 weeks  
to compare the side effect profile between two groups at 3 weeks 6 weeks 9 weeks 12 weeks follow up  3 weeks 6 weeks 9 weeks 12 weeks 
to compare relapse rate at 24 weeks in both groups   24 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 
Date of First Enrollment (India)   27/01/2026 
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="9"
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   To compare the efficacy of intralesional triamcinolone acetonide injection with hyaluronidase and PRP vs intralesional triamcinolone acetonide injection with hyaluronidase in the treatment of keloids when given 3 weekly for 4 doses as assessed by mean Vancouver scar scale at 12 weeks follow up. 
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