| CTRI Number |
CTRI/2025/11/097031 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intralesional MMR (Measles,mumps and rubella) vs intralesional BCG (Bacillus calmette-guerin) in the treatment of Verucca vulgaris |
|
Scientific Title of Study
|
Intralesional MMR (Measles,mumps and rubella) vs intralesional BCG (Bacillus calmette
-guerin)in the treatment of Verucca vulgaris: A Randomized controlled 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 |
Ravish Bhourya |
| Designation |
Post Graduate Trainee |
| Affiliation |
Jawaharlal Nehru Institute Of Medical Sciences |
| Address |
Department of Dermatology,Room no.305,3rd Floor,OPD building Jawaharlal Nehru Institute of medical Sciences,Porompat, Imphal, Manipur 795004
Imphal East
MANIPUR
795004
India |
| Phone |
8319989195 |
| Fax |
|
| Email |
ravishbhourya010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranjeeta Sapam |
| Designation |
Head of Department and Professor,Department of Dermatology |
| Affiliation |
Jawaharlal Nehru Institute Of Medical Sciences |
| Address |
Department of Dermatology,Room no.307,OPD building,3rd floor,Jawaharlal Nehru Institute of medical Sciences,Porompat, Imphal, Manipur 795004
Imphal East
MANIPUR
795004
India |
| Phone |
9436891550 |
| Fax |
|
| Email |
ranssapam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravish Bhourya |
| Designation |
Post Graduate Trainee |
| Affiliation |
Jawaharlal Nehru Institute Of Medical Sciences |
| Address |
Department of Dermatology,Room no.305,3rd Floor,OPD building,Jawaharlal Nehru Institute of medical Sciences,Porompat, Imphal, Manipur 795004
Imphal East
MANIPUR
795004
India |
| Phone |
8319989195 |
| Fax |
|
| Email |
ravishbhourya010@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Institute Of Medical Sciences,Porompat,Imphal East,795004 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Institute Of Medical Sciences |
| Address |
Jawaharlal Nehru Institute Of Medical Sciences,Porompat,Imphal East ,795004 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravish Bhourya |
Jawaharlal Nehru Institute of medical Sciences |
Department of Dermatology,Room no.305,3rd Floor,OPD building,Jawaharlal Nehru Institute Of Medical Sciences,Porompat,Imphal East,795004
Imphal East
MANIPUR |
8319989195
ravishbhourya010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,JNIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B078||Other viral warts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INTRALESIONAL BCG(Bacillus calmette-guerin)-Group B |
Name: Intralesional Bacillus Calmette–Guérin (BCG) Vaccine
Type: Biological (live attenuated bacterial vaccine)
Description:
Each participant in Group B (BCG group) will receive 0.1 mL of reconstituted freeze-dried BCG vaccine injected intralesionally into the single largest wart using a 30G insulin syringe with the bevel end facing upward.
The injection will be repeated every 3 weeks for a total of 4 treatment sessions (0, 3, 6, 9 weeks) or until complete clearance, whichever occurs earlier.
The vaccine will be reconstituted with 1 mL sterile normal saline before each use.
Duration of administration: Up to 9 weeks (maximum 4 doses at 3-week intervals).
Follow-up: 3 and 6 months after last dose.
Route of administration: Intralesional
Dose per administration: 0.1 mL |
| Intervention |
INTRALESIONAL MMR(Measles,mumps and rubella)-Group A |
Name: Intralesional Measles, Mumps and Rubella (MMR) Vaccine
Type: Biological (live attenuated viral vaccine)
Description:
Each participant in Group A (MMR group) will receive up to 0.5 mL of reconstituted freeze-dried MMR vaccine injected intralesionally into a single or a maximum of five verruca vulgaris lesions at a time, using a 31G insulin syringe with the bevelled edge facing upward.
The vaccine will be administered every 3 weeks for a maximum of 5 doses or until complete clearance of warts, whichever occurs earlier.
The vaccine will be reconstituted immediately before use as per manufacturer’s instructions with provided diluent.
Duration of administration: Up to 15 weeks (maximum 5 doses at 3-week intervals).
Follow-up: 3 months after last dose.
Route of administration: Intralesional
Dose per administration: 0.5 mL (adjusted to lesion size, total not exceeding 0.5 mL per sitting) |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Clinically diagnosed verruca vulgaris patients.
2) No concurrent treatment for verruca vulgaris. |
|
| ExclusionCriteria |
| Details |
1) Patients with signs and symptoms of infection.
2) Pregnancy and lactation.
3) Age less than 12 years
4) Immunocompromised Individuals.
5) Patients with chronic disease.
6) Patients with a history of asthma and allergic skin disorders. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients achieving complete clearance (100% on VAS) (primary binary outcome used for sample size), assessed at the scheduled follow-ups (treatment visits and final assessment). |
The proportion of patients achieving complete clearance (100% on VAS) (primary binary outcome used for sample size), assessed at the scheduled follow-ups (treatment visits and final assessment).-at 3,6,9 and 12weeks and 3months after last dose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Incidence and severity of adverse effects. |
1.Incidence and severity of adverse effects.-in weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/11/2025 |
| 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="24"
Months="0"
Days="2" |
|
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 - NO
|
|
Brief Summary
|
A study on the topic “Intralesional MMR (Measles, Mumps and Rubella) Versus Intralesional BCG (Bacillus calmette -guerin) in the treatment of Verruca Vulgaris: A Randomized Controlled Study”. The study will be conducted for 2-year duration among all verruca vulagris patients attending the Department of Dermatology, Venereology and leprosy of JNIMS during the study interval. The objective of the study is to assess the efficacy of IL MMR and IL BCG and to compare the efficacy of both in the treatment of verruca vulgaris and to determine the Dermatology Life Quality Index in wart patients. In this study, patients with clinically diagnosed verruca vulgaris above 12 years of age will be included. Patients undergoing immunosuppression, underwent any other treatment in the last month before enrolment, pregnant/lactating women, patients with fever or any signs of inflammation or infection, patients with past history of asthma, allergic skin disorders and patients with chronic disease will be excluded. Though number of studies on the subject has been done all over the world, similar studies in India is very few and therefore this study has been taken up to assess the same and compare with rest of the studies. |