FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/02/103458 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Vaccine 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing Injection Acyclovir And Vaccine MMR In The Treatment Of Viral Warts 
Scientific Title of Study   A Prospective Comparative Interventional Study to Determine the Safety and Efficacy of Intralesional Acyclovir versus Vaccine MMR in the treatment of Viral warts- RANDOMIZED CONTROL TRIAL 
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 K Vidhi Jain 
Designation  Junior Resident 
Affiliation  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH DEEMED TO BE UNIVERSITY, BELGAVI 
Address  SKIN OPD 23, G1 FLOOR, KLE PRABHAKAR KORE HOSPITAL , BELGAVI , INDIA

Belgaum
KARNATAKA
590010
India 
Phone  8978310953  
Fax    
Email  vidhijain241@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijaya Sajjan  
Designation  Associate Professor  
Affiliation  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH DEEMED TO BE UNIVERSITY, BELGAVI 
Address  SKIN OPD 23, G1 FLOOR, KLE PRABHAKAR KORE HOSPITAL , BELGAVI , INDIA

Belgaum
KARNATAKA
590010
India 
Phone  9880503069  
Fax    
Email  vijaya_sajjan@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr K Vidhi Jain 
Designation  Junior Resident 
Affiliation  KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH DEEMED TO BE UNIVERSITY, BELGAVI 
Address  SKIN OPD 23, G1 FLOOR, KLE PRABHAKAR KORE HOSPITAL , BELGAVI , INDIA

Belgaum
KARNATAKA
590010
India 
Phone  8978310953  
Fax    
Email  vidhijain241@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr K Vidhi Jain  
Address  SKIN OPD 23, G1 FLOOR, KLE PRABHAKAR KORE HOSPITAL, BELGAVI  
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 K Vidhi Jain  KLE PRABHAKAR KORE HOSPITAL , BELAGVI  SKIN OPD 23, G1 FLOOR, KLE PRABHAKR KORE HOSPITAL , BELGAVI
Belgaum
KARNATAKA 		 8978310953

vidhijain241@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INJECTION ACYCLOVIR   INJECTION ACYCLOVIR WILL BE GIVEN INTRALESIONALLY IN THE VIRAL WART LESION AT REGULAR INTERVALS 
Comparator Agent  VACCINE MMR   VACCINE MMR WILL BE GIVEN INTRALESIONALLY IN THE VIRAL WART LESION AT REGULAR INTERVALS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosed cases of plantar, palmar, periungual, and subungual warts
2. Age between 18 years and 65 years 
 
ExclusionCriteria 
Details  1.Known history of hypersensitivity to Acyclovir and MMR vaccine
2.Pregnancy and lactation
3.Immunocompromised status
4.Secondary infection/ulceration.
5.Patients with fever or signs of any inflammation or infection, meningitis, and convulsions.
6.Patients with any history of asthma, allergic skin disorders, hypersensitivity, or allergy to vaccines.
7.Patients with any history of concurrent systemic, or topical treatment of warts within the past 4 weeks.
8.Patients with genital/mucosal warts/plane warts.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
CHANGE IN SIZE AND NUMBER OF LESIONS AFTER TREATMENT  BASELINE ( WEEK0), WEEK 2, WEEK 4, WEEK 6, WEEK 8
 
 
Secondary Outcome  
Outcome  TimePoints 
1.PATIENT SATISFACTION SCALE BY VISUAL ANALOGUE SCALE
2.SIDE EFFECTS EVALUATION  		 BASELINE ( WEEK0), WEEK 2, WEEK 4, WEEK 6, WEEK 8 
 
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)   14/02/2026 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vidhijain@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This study is a prospective, randomized, comparative interventional trial designed to evaluate and compare the efficacy and safety of intralesional acyclovir versus intralesional MMR vaccine in the treatment of cutaneous viral warts. Viral warts, caused by human papillomavirus (HPV), are common dermatological conditions with variable response to conventional destructive therapies and a tendency for recurrence, prompting the need for effective immunomodulatory or antiviral alternatives 

A total of 60 adult patients (>18 years) with clinically diagnosed palmar, plantar, periungual, or subungual warts will be recruited and randomly allocated into two groups. Group A will receive intralesional acyclovir (70 mg/mL), and Group B will receive intralesional MMR vaccine, administered every two weeks for up to six sessions or until complete clearance. Treatment response will be assessed using objective reduction in wart size and number (graded G0–G4), physician global assessment, and patient satisfaction scores, with follow-up for adverse effects and short-term recurrence 

The primary objective is to compare therapeutic efficacy between the two modalities, while secondary objectives include evaluation of safety and tolerability. 

 
Close