| CTRI Number |
CTRI/2024/02/062715 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative analysis of efficacy between autoimplantation and intralesional MMR vaccine in viral warts |
|
Scientific Title of Study
|
Comparative analysis of efficacy between homologous autoimplantation therapy and intralesional MMR vaccine in the treatment of viral warts. |
| Trial Acronym |
MAVW |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anusha N A |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Dermatology and VD OPD 23, Room number 2,KLEH Dr Prabhakar Kore Hospital, Belagavi 590010, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8884343473 |
| Fax |
|
| Email |
anunagral94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharada V G |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Dermatology and VD OPD 23, Room number 2,KLEH Dr Prabhakar Kore Hospital, Belagavi 590010, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8971670453 |
| Fax |
|
| Email |
sharada24101992@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi P Shete |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi |
| Address |
Dermatology and VD OPD 23, Room number 2,KLEH Dr Prabhakar Kore Hospital, Belagavi 590010, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9371011096 |
| Fax |
|
| Email |
aditishete52@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEH Dr Prabhakar Kore Hospital and Medical Research Institute |
|
|
Primary Sponsor
|
| Name |
KLEH Dr Prabhakar Kore Hospital and Medical Research Institute |
| Address |
Dermatology OPD 23, Room number 2, KLEH Dr Prabhakar Kore Hospital, Belagavi 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anusha NA |
KLES Dr Prabhakar Kore Hospital, Belagavi |
Room No. 2,Dermatology OPD 23 , KLEH, Dr Prabhakar Kore Hospital, Belagavi
Belgaum
KARNATAKA |
8884343473
anunagral94@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
|
|
|
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 |
| Comparator Agent |
Homologous autoimplantation |
Full thickness excision of one wart is made and after mincing it, these particles are introduced in the dermal pocket made on flexor aspect of non-dominant forearm 2 inches below ante-cubital fossa |
| Intervention |
Intralesional Injection MMR |
0.5 ml Injection MMR injected in each cutaneous wart at a interval of 3 weeks upto 5 sittings |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients more than 12 years of age with multiple warts less than 10 in number who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1)Single wart
2)Pregnant or planning pregnancy in the next three months
3)Lactating women
4)Patients with local dermatological condition
5)Patients with apparent infection, immunosuppression, or are on immunosuppressive drugs, asthma, allergic skin disorders, meningitis or convulsions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in size of wart assessed by VAS scoring system |
Baseline,3 weeks, 6 weeks, 9 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess adverse reactions in Inralesional Injection MMR & Autoimplantation |
Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| 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="3"
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
|
Purpose of the trial - Multiple warts are difficult to treat with destructive procedures like fulguration and ablation as they may cause permanent scarring. Immunotherapy using intralesional MMR vaccine has been found useful in treating common warts especially in children. Homologous autoimplantation is a simple technique, which helps in inducing a good cell-mediated immune response, essential for the clearance of warts. Only few studies have evaluated the efficacy of intralesional MMR and Autoimplantation with equivocal results. Brief Summary To do comparative analysis of safety and efficacy between homologous autoimplantation therapy and intralesional MMR vaccine in the treatment of viral warts. Study design is Randomised Control Trial. Patients more than 12 yrs of age with multiple warts (less than 10 in number), non-pregnant, non-lactating, immunocompetent who are willing to participate will be enrolled in the study after taking informed consent. Sample size is 56, 28 in each group Intralesional MMR and homologous autoimplantation respectively. Time points for assessment will be baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks. Assessment will be done using VAS score at each time point. Data will be analysed using statistical software R version 4.2.3 and Microsoft Excel. |