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CTRI Number  CTRI/2023/05/053231 [Registered on: 29/05/2023] Trial Registered Prospectively
Last Modified On: 12/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Vaccine 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of intralesional Injection Vitamin D3 with intralesional MMR vaccine in the management of cutaneous warts 
Scientific Title of Study   Comparison of efficacy of intralesional Vitamin D3 with intralesional MMR vaccine in the management of cutaneous warts : a randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chrisinder Kaur 
Designation  Post graduate student 
Affiliation  INHS Asvini 
Address  INHS Asvini,near RC Church,colaba,Mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  07017520062  
Fax    
Email  kaurchrisinderkaur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  G R Rajput 
Designation  Doctor 
Affiliation  INHS Asvini 
Address  INHS Asvini,near RC Church,colaba,Mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  07017520062  
Fax    
Email  gopal.270985@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reetu Aggrawal 
Designation  Professor , dept of dermatology,INHS Asvini 
Affiliation  INHS Asvini 
Address  INHS Asvini,near RC Church,colaba,Mumbai

Mumbai
MAHARASHTRA
400005
India 
Phone  07017522061  
Fax    
Email  reetuaggarwal@gmail.com  
 
Source of Monetary or Material Support  
INHS Asvini 
 
Primary Sponsor  
Name  INHS Asvini dermatology dept 
Address  INHS Asvini colaba Mumbai 
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 
Chrisinder Kaur  INHS Asvini  INHS Asvini near Rc Church colaba mumbai
Mumbai
MAHARASHTRA 		 917017520062

kaurchrisinderkaur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee INHS Asvini  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Cutaneous warts 
Patients  (1) ICD-10 Condition: B079||Viral wart, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  MMR Vaccine  Measles Mumps Rubella vaccine 0.3 ml every 2 weeks for total of 4 doses for till resolution of lesions whichever is earlier 
Intervention  Vitamin D3 injection  Injection Vitamin D3 0.2ml every 2 weeks for total of 4 doses or till resolution whichever is earlier.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All diagnosed immunocompetent cases (clinically and dermoscopically) of cutaneous warts (aged 5-70 yrs) attending Dermatology OPD in a tertiary care hospital in Mumbai. 
 
ExclusionCriteria 
Details  Patients with keloidal tendencies.
(2) Patients with prior allergic response to MMR or vitamin D3.
(3)Patients with autoimmune conditions.
(4) Patients with infected warts
(5) Patients with genital warts.
(6) Pregnant /lactating females.
(7) Known case of HIV/HBsAg/HCV
(8)Immunosuppressed patients.
(9) Consent Denial, uncooperative patients. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of resolution of injected warts.  Resolution of warts at weeks 2, 4, 6,24 
 
Secondary Outcome  
Outcome  TimePoints 
To compare effect of intralesional Vitamin D3 vs MMR vaccine on the resolution of distant warts, other than injected warts  weeks 2,4,6,24 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   06/06/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
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) -  nil

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report
    Response (Others) -  nil
  3. Who will be able to view these files?
    Response (Others) -  nil

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

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

  6. For how long will this data be available start date provided 12-12-2024 and end date provided 12-02-2025?
    Response (Others) -  nil

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
 All clinically and dermoscopically diagnosed immunocompetent patients of cutaneous warts (aged 5-70 years) attending dermatology OPD at a tertiary care hospital in western Maharashtra within study period would be offered to participate in the study.
- All patients who would agree and fulfill inclusion criteria would be selected. A written and informed consent of the patient would be taken prior to the procedure.
- Clinical examination of the study population with recording of number, site and size of the warts (on millimetre scale) and clinical photographs would be taken. In case of multiple warts, the size of all the warts would be
calculated for assessing the response. Semitransparent paper would be used to map and measure the warts.
• Simple randomization would be done with consecutive patients and they will receive the intervention according to the treatment group with Group A (intralesional vitamin D3) and Group B (intralesional MMR Vaccine).
• Group A- will receive intralesional Vitamin D3 into the base of largest wart.
• Group B- will receive intralesional MMR  into the base of largest wart.
• All treatments to be continued for 4 sessions (2 weeks apart). In case of resolution of largest wart, next largest wart will be injected till completion of total four dosages overall. Photographs would be taken at every session and till 6 months of last dose. Response would be recorded as resolution of injected warts as excellent (75-100%), good (50-74%), partial (25-49%), poor response(0-24%). Similarly response would be seen in distant warts.
 
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