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CTRI Number  CTRI/2024/09/073176 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 30/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A combination of Triamcinolone Acetonide 5 fluorouracil and Verapamil injection for treatment of keloid in adults 
Scientific Title of Study   A combination of Triamcinolone Acetonide 5 Fluorouracil 5 FU and Verapamil intralesional injection for treatment of Keloid in adults An Interventional Study 
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 Nachiket Palaskar 
Designation  Associate Professor 
Affiliation  YCM hospital 
Address  OPD NO 108, Department of dermatology PCMC PGI, YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra
OPD NO 108, Department of dermatology PCMC PGI, YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA
411018
India 
Phone  9422349134  
Fax    
Email  nachiketpalaskar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nachiket Palaskar 
Designation  Associate Professor 
Affiliation  YCM hospital 
Address  OPD NO 108, Department of dermatology PCMC PGI, YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra
OPD NO 108, Department of dermatology PCMC PGI, YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA
411018
India 
Phone  9422349134  
Fax    
Email  nachiketpalaskar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nachiket Palaskar 
Designation  Associate professer  
Affiliation  PCMC PGI YCM Hospital 
Address  OPD NO 108, Department of dermatology PCMC PGI, YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra
OPD NO 108, Department of dermatology PCMC PGI, YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA
411018
India 
Phone  9422349134  
Fax    
Email  nachiketpalaskar@gmail.com  
 
Source of Monetary or Material Support  
YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad,India, Maharashtra 411018 
 
Primary Sponsor  
Name  YCM Hospital 
Address  OPD NO 108, Department of dermatology PCMC PGI, YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra  
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 Aarti Chawla  YCM Hospital  OPD NO 108, Department of dermatology PCMC PGI, YCM Hospital, YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Pimpri-Chinchwad, Maharashtra
Pune
MAHARASHTRA 		 8208120950

draartichawla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PCMCs PGI YCMH Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L91||Hypertrophic disorders of skin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intralesional injection of a combination of Triamcinolone Acetonide (40 mg/ml), 5 FU (50mg/ml), and Verapamil(2.5mg/ml)   Each patient will undergo a detailed history review, including demographic parameters, etiology, and keloid region, after the keloid diagnosis based on history and clinical examination. • The patient will receive an intralesional injection of a combination of Triamcinolone Acetonide (40 mg/ml), 5 FU (50mg/ml), and Verapamil (2.5mg/ml) in a ratio of 2:1:1 using an insulin syringe after application of eutectic mixture of local anesthetics (EMLA) cream. The volume injected will be 0.1ml per square centimeter of keloid. A maximum of 2 ml will be injected per session. • 4 injections will be administered at 3 weeks intervals . • The patient will be evaluated prior to every injection, and at 1 month and 3 months after the last injection, using POSAS. • Adverse effects due to injection and any other complaints will be recorded. 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1) Patients having keloid and willing to give a consent
2) Age group above 18 years 
 
ExclusionCriteria 
Details  1) Secondary infection of keloid
2) Patients having blood dyscrasias 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of combination of Triamcinolone
Acetonide, 5-Fluorouracil(5-FU) and Verapamil intralesional injection therapy
in the treatment of keloid , employing the Patient and Observer Scar
Assessment Scale (POSAS) 		 18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effects following the injection .  18 months 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  15/09/2024 
Date of Study Completion (Global) 15/06/2026 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
1) Keloid still possesses a challenge for clinicians as they are difficult to treat and there is no specific treatment guideline for it.Many treatment modalities are there and various medicine injections have been tried in the treatment of keloid.
2) Verapamil, a calcium channel antagonist, has been recommended in the management of keloids because of its ability to decrease extracellular matrix production and modify fibroblast to increase secretion of procollagenase.
3) Intralesional corticosteroids injection , provide the best relief of local symptoms as well as flattening of the scars themselves due to their anti inflammatory and scar enhancing properties.
4) 5-Fluorouracil(5-FU) selectively inhibits fibroblast proliferation and collagen synthesis.
5) Currently, intralesional corticosteroids is the gold standard non surgical management for keloids.
6) Two medicine combinations of Triamcinolone Acetonide (40 mg/ml) +5 FU (50mg/ml) and Triamcinolone Acetonide (40 mg/ml) +Verapamil (2.5mg/ml) have been tried with good results.
7) The introduction of a triple combination therapy of Triamcinolone Acetonide (40 mg/ml), 5 FU (50mg/ml), and Verapamil (2.5mg/ml) aims to enhance treatment efficacy and expedite the resolution of keloid
8) The lesions and symptoms associated as such impacts the social and interpersonal relation of patients.So it is very important to find solution that will decrease the recurrence and help patient to achieve easy and faster remission.

Update 1:

Number of patients enrolled - 94

Number of patients who completed the study - 10

Number of patients showing loss to follow up - 27

Number of patients showing no result - 1

Adverse Effects - All side-effects were seen locally over keloid

  1. Hypopigmentation
  2. Telangiectasia
  3. Ulceration
  4. Vesicle followed by erosion
  5. Comedones
Final Update

Number of patients who completed the study - 56. 

Number of patients showing no result - 1

Adverse Effects - All side-effects were seen locally over keloid

  1. Hypopigmentation
  2. Telangiectasia
  3. Ulceration
  4. Vesicle  
  5. Comedones
  6. erosion
  7. injection site pain
 
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