| CTRI Number |
CTRI/2024/11/077359 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Intralesional MMR and Intralesional Vitamin D3 in treatment of cutaneous warts using dermoscopy
|
|
Scientific Title of Study
|
Evaluation of efficacy of intralesional MMR with Vitamin D3 in cutaneous warts using dermoscopy
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1313-9310 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ketaki Shaha |
| Designation |
Junior resident |
| Affiliation |
Teerthankar Mahaveer Medical College and Research Centre |
| Address |
Department of DVL, Teerthankar Mahaveer Medical college and research centre, NH24 Delhi road, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9561019222 |
| Fax |
|
| Email |
ketki1521999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Meena |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer Medical College and Research Centre |
| Address |
Department of DVL, Teerthankar Mahaveer Medical college and research centre, NH24 Delhi road, Bagadpar, Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8191811380 |
| Fax |
|
| Email |
dilip.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilip Meena |
| Designation |
Professor |
| Affiliation |
Teerthankar Mahaveer Medical College and Research Centre |
| Address |
Department of DVL, Teerthankar Mahaveer Medical college and research centre, NH24 Delhi road, Bagadpur, Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8191811380 |
| Fax |
|
| Email |
dilip.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthankar Mahaveer Medical College and Research Centre, NH24 Delhi Road , Moradabad 244001, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Teerthankar Mahaveer Medical College and Research Centre |
| Address |
Teerthankar Mahaveer Medical XpCollege and Research centre, NH24 Delhi road, Moradabad |
| Type of Sponsor |
Private 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 Ketaki Shaha |
Teerthankar Mahaveer Medical college and research centre |
Department of DVL, Teerthanakr Mahaveer Medical College and Research Centre, NH24 Delhi Road, Bagadpur,Moradabad,Moradabad
Moradabad
UTTAR PRADESH |
9561019222
ketki1521999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthankar Mahaveer University- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B079||Viral wart, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intralesional injection of Inj Vitamin D3(6,00,000IU; 15 mg/ml) |
Patients will receive intralesional injection of upto 0.5 mL of Inj Vitamin D3(6,00,000IU; 15 mg/ml)into a wart each session after injection of IL lignocaine with 31 G insulin syringe.Amount of injection on each wart will depend on the size of each wart. The intralesional injection will be given every three weeks for a maximum of 4 doses or until complete resolution, whichever is earlier.Photographic and Dermoscopic comparison will be used to assess decrease in size and number of warts and thus the response to treatment and clinical response will be noted.
Follow up will be made every monthly for 3 months
|
| Comparator Agent |
Intralesional injection of reconstituted MMR vaccine |
Patients will receive a intralesional injection of upto of 0.5ml of reconstituted MMR vaccine into wart in each session with 31 G insulin syringe. Amount of injection on each wart will depend on the size of each wart. The intralesional injection will be given every three weeks for a maximum of 4 doses or until complete resolution, whichever is earlier.Photographic and Dermoscopic comparison will be used to assess decrease in size and number of warts and thus the response to treatment and clinical response will be noted. Follow up will be made every monthly for 3 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed patients of warts attending the Department of Dermatology, Venereology & Leprosy(both out-patient and in-patient)of Teerthankar Mahaveer Medical College,Moradabad(UP)
2. Age from 12 years to 70 years of both sexes
3.Patients giving informed and willing consent |
|
| ExclusionCriteria |
| Details |
1.Patients under any systemic or topical treatment of warts for the last 4 weeks
2.PatientswithapasthistoryofanallergicresponsetoMMRoranyothervaccineorVitaminD3.
3.Patientswithcurrentacutefebrileillness,anybacterialinfection,immunocompromisedandonimmunosuppressants
4.Pregnantandlactatingfemales
5.Patientswithhistoryofkeloid |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To determine the efficacy of IL MMR vaccine in the treatment of warts.
• To determine the efficacy of IL vitamin D3 in the treatment of warts.
• To compare the efficacy of IL MMR vaccine and IL Vitamin D3 during follow up using dermoscopy.
To identify various dermoscopic features of warts before and after immunotherapy. |
3,6,9,12 weeks,1,2,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the side effects of IL MMR vaccine and IL Vitamin D3 in treatment of warts. |
3,6,9,12 weeks,1,2,3 months |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
01/12/2024 |
| 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="1"
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
|
All patients attending DVL OPD at TMU Hospital clinically diagnosed with warts with or without distant warts meeting the inclusion and exclusion criteria to be enrolled in the study. Investigator blinding will be done. Based on computer generated random number table, patients will be assigned to either Group A or Group B and allocation concealment will be done while assigning groups. A detailed history will be taken and dermatological examination will be done.Dermoscopic evaluation would be done using both polarized and non-polarized mode using Dermlite DL5 dermoscope at baseline and in subsequent treatment session by other investigator. Structured case record form would be used for the purpose of recording of history and examination findings. All Group A patients will receive intralesional injection of upto 0.5 mL of Inj Vitamin D3(6,00,000IU; 15 mg/ml)into a wart each session after injection of IL lignocaine with 31 G insulin syringe All Group B patients will receive a intralesional injection of upto of 0.5ml of reconstituted MMR vaccine into wart in each session with 31 G insulin syringe. Amount of injection on each wart will depend on the size of each wart. The intralesional injection will be given every three weeks for a maximum of 4 doses or until complete resolution, whichever is earlier. Photographic and Dermoscopic comparison will be used to assess decrease in size and number of warts and thus the response to treatment and clinical response will be noted. Follow up will be made every monthly for 3 months.
|