FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/01/039579 [Registered on: 19/01/2022] Trial Registered Prospectively
Last Modified On: 17/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A STUDY TO COMPARE THE EFFECTIVENESS AND SAFETY OF INTRALESIONAL VITAMIN D3 WITH INTRALESIONAL TRIAMCINOLONE IN PATIENTS WITH KELOIDS. 
Scientific Title of Study   A DOUBLE-BLINDED RANDOMIZED CONTROL STUDY TO COMPARE THEEFFECTIVENESS AND SAFETY OF INTRALESIONAL VITAMIN D3 WITH INTRALESIONAL TRIAMCINOLONE AND IT’S CORRELATION WITH TISSUE EXPRESSION OF VITAMIN D RECEPTORS IN PATIENTS WITH KELOID 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aman goyal 
Designation  Junior resident 
Affiliation  PGIMER CHANDIGARH 
Address  Room no 3,level 2D,Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9425719279  
Fax    
Email  amangoyal0206@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tarun narang 
Designation  Associate professor 
Affiliation  PGIMER CHANDIGARH 
Address  Room no 3,level 2D,Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9316063166  
Fax    
Email  narangtarun2012@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aman goyal 
Designation  Junior resident 
Affiliation  PGIMER CHANDIGARH 
Address  Room no 3,level 2D,Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012

Chandigarh
CHANDIGARH
160012
India 
Phone  9425719279  
Fax    
Email  amangoyal0206@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF DERMATOLOGY PGIMER CHANDIGARH 
 
Primary Sponsor  
Name  DEPARTMENT OF DERMATOLOGY PGIMER CHANDIGARH 
Address  Room no 3,level 2D,Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012 
Type of Sponsor  Research institution and hospital 
 
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 Aman goyal  DEPARTMENT OF DERMATOLOGY PGIMER CHANDIGARH  Room no 3,level 2D,Nehru hospital block, department of dermatology, PGIMER CHANDIGARH 160012
Chandigarh
CHANDIGARH 		 9425719279

amangoyal0206@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee (intramural) PGIMER , Chandigarh  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  Injection triamcinolone  Dose- intralesional injection of triamcinolone at 20mg/ml with a dose of 0.1 ml per cm2 of keloid. Frequency- Once every 4 weekly for 4 months. Route - Intralesional locally at the site. 
Intervention  INJECTION VITAMIN D3   DOSE- Intralesional injection of vitamin D3 at 0.2 ml(200,000 IU)with a dose of 0.2 ml per cm2of keloid. Frequency- Once every 4 weekly for 4 months. Route - Intralesional locally at the site.  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient with single keloid or multiple (upper limit 5) of more than 6-month duration. Every keloid selected for study is considered a different entity.
2. Keloids of size <10cm2 .
3. The patient who can give valid consent.
 
 
ExclusionCriteria 
Details  1. Patient with any previous interventional treatment for the same keloid in the 6 months preceding enrollment
2. Pregnant or lactating females or women who are planning a pregnancy
3. Keloids on the face
4. Immunosuppressed patients
5. Patient with chronic inflammatory diseases; patients with a history of renal or liver failure
6.Patients with a history of hypersensitivity to any of the study drugs
7. Patients with a history of non-responsiveness to any of the treatment modalities
8. The patient who is not willing to provide consent for the study.
9. Patient with active inflammation, infection, or ulcer in and around the keloid
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of patient achieving 50% reduction in scar score by measuring the difference in Vancouver scar scale in the group receiving intralesional injection vitamin D3 versus the injection triamcinolone group.  At the end of 4,8,12,16,24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To determine differences in VDR expression in keloid pathology by comparing tissue VDR expression pre and post-treatment  At the end of 4,8,12,16,24 weeks 
Adverse events during the treatment  At the end of 4,8,12,16,24 weeks 
Mean difference in quality of life of patients before and after treatment  At the end of 4,8,12,16,24 weeks 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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   N/A 
Date of First Enrollment (India)   20/01/2022 
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="11"
Days="11" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Pathological scars are a common benign disorder. They are commonly seen among people with a racial predisposition. Those with a history of burns, trauma, surgery, infections like folliculitis and acne are more prone to develop pathological scars. These consist of excess collagen deposition in scar tissue which leads to significant symptoms like itching, pain, and cosmetic issues to the patient.

Hypertrophic scars are red, raised, or itchy lesions occurring as a result of burns or surgical wounds seen more in lighter-skinned people. On histology, organized type3 collagen deposition is seen.

Keloid scars are abnormal scars that appear as raised amorphous growth associated with pain and itching and extend beyond original wound boundaries. Despite treatment, there are chances of recurrence, nearly 100% recurrence is seen after surgical excision but surgical excision followed by postoperative intralesional steroid injection seems to provide a reasonable treatment outcome with a low recurrence rate.

Vitamin D is a fat-soluble vitamin that is required for the human body. It is involved in calcium homeostasis, cell proliferation inhibition, cell differentiation promotion, inflammation, and apoptosis. According to a study, reduced vitamin D receptor (VDR) expression and nuclear localization of  VDR  may have a role in keloid pathogenesis.2

 So there is an assumption of a link between the role of VDR in keloid pathology and the efficacy of vitamin D as therapy in a keloid scar. There are no head-to-head comparisons of intralesional triamcinolone and intralesional vitamin D3 andhence we have endeavored to compare the effectiveness and safety of these two treatment modalities in patients with keloids.

What is already known on this topic?

Keloid scars are abnormal scars that appear as raised amorphous growth associated with pain and itching and extend beyond original wound boundaries. Intralesional steroids are the first line of treatment. Combination therapy have better role in cure and recurrence. Also vitamin d3  receptors  have role in keloid pathology.There are few pilot studies that have observed that vit d may help in treatment of keloids.

What will this study add to existing knowledge?

There are no study regarding comparisons of intralesional triamcinolone and intralesional vitamin d3 andhence we have endeavored to compare the effectiveness and safety of these two treatment modalities in patients with keloids.

 
Close