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CTRI Number  CTRI/2023/12/060907 [Registered on: 28/12/2023] Trial Registered Prospectively
Last Modified On: 24/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of intralesional 5-fluorouracil with MMR vaccine in warts 
Scientific Title of Study   Comparative efficacy of intralesional 5-Fluorouracil and intralesional MMR vaccine in verruca vulgaris 
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 Aashali 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh India

Chandigarh
CHANDIGARH
160030
India 
Phone  9416988079  
Fax    
Email  aashali411@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jasleen Kaur 
Designation  Associate Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646481249  
Fax    
Email  jasleenksandhu21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jasleen Kaur 
Designation  Associate Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646481249  
Fax    
Email  jasleenksandhu21@gmail.com  
 
Source of Monetary or Material Support  
Government Medical College and Hospital, Chandigarh 
 
Primary Sponsor  
Name  Department of Dermatology 
Address  Government Medical College and Hospital, Sector 32B, Chandigarh, 160030 
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 Aashali  Government Medical College and Hospital, Chandigarh  Dermatology Venereology and leprosy OPD 4th floor B block Government Medical College and Hospital Sector 32B Chandigarh 160030
Chandigarh
CHANDIGARH 		 9416988079

aashali411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee GMCH Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B079||Viral wart, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  5-Fluorouracil  26 patients will be given intralesional 5-Fluorouracil in all lesions at 2 weekly intervals for a total of 5 sessions 
Comparator Agent  MMR vaccine  26 patients will be given intralesional MMR vaccine in the largest lesion at 2 weekly intervals for a total of 5 sessions 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All consecutive patients having lesions of verruca vulgaris.
2. Patients between the ages of 14-60 years. 
 
ExclusionCriteria 
Details  1. Pregnant or females planning for pregnancy or lactating mothers.
2. Immunocompromised individuals including HIV-AIDS.
3. Patients with known hypersensitivity to MMR vaccine or components of the vaccine (e.g. neomycin, gelatin) or 5-FU.
4. Patients having any significant systemic illness.
5. Patients having taken any vaccine in the last 4 weeks. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of intralesional 5-FU and intralesional MMR vaccine therapy in verruca vulgaris  0, 2, 4, 6, 8, 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the adverse effects of these therapies  0, 2, 4, 6, 8, 12 weeks 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   04/01/2024 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Verruca vulgaris is a common dermatological condition. Current treatment options for verruca vulgaris include destructive, topical and immunological therapies. MMR vaccine has an immunomodulatory activity and has been postulated to have effect on injected as well as distant warts with almost no side effects except pain at injection site in patients of warts. 5-FU has a cytotoxic effect and when given intralesionally shows an early response to treatment, have high clearance rates and less recurrence rate. This study aims at making a comparison between the therapeutic efficacy of I/L 5-FU and I/L MMR vaccine as there are no head to-head studies in the literature comparing the efficacy of intralesional 5-FU and intralesional MMR vaccine in similar settings. 
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