| CTRI Number |
CTRI/2025/11/096747 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
02/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of injecting vitamin D3 into warts among people with verruca |
|
Scientific Title of Study
|
Role of intralesional Vitamin D3 in the treatment of cutaneous warts– At a
Tertiary Care Center in Central Karnataka |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K S ANISHA KABEER |
| Designation |
POST GRADUATE |
| Affiliation |
JJM MEDICAL COLLEGE |
| Address |
JJM MEDICAL COLLEGE
MCC B BLOCK, DAVANGERE
Davanagere
KARNATAKA
577004
India |
| Phone |
9620198336 |
| Fax |
|
| Email |
kabeeranish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MANGALA H C |
| Designation |
PROFESSOR |
| Affiliation |
JJM MEDICAL COLLEGE |
| Address |
JJM MEDICAL COLLEGE
MCC B BLOCK, DAVANGERE
Davanagere
KARNATAKA
577004
India |
| Phone |
9620198336 |
| Fax |
|
| Email |
drhcmangala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K S ANISHA KABEER |
| Designation |
POST GRADUATE |
| Affiliation |
JJM MEDICAL COLLEGE |
| Address |
JJM Medical College
MCC B Block, Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
9620198336 |
| Fax |
|
| Email |
kabeeranish@gmail.com |
|
|
Source of Monetary or Material Support
|
| JJM MEDICAL COLLEGE
MCC B BLOCK, Davangere
Karnataka-577004 |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology |
| Address |
JJM Medical College, MCC B Block, Davangere |
| 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 |
| K S ANISHA KABEER |
JJM MEDICAL COLLEGE |
Department of dermatology, room 9 , MCC B Block, Davangere-577004
Davanagere
KARNATAKA |
9620198336
kabeeranisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, JJM MEDICAL COLLEGE,DAVANGERE |
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 VITAMIN D3 |
Intralesional vitamin D3 (600000 IU/ampoule), administered at a dose of 0.2-0.3 ml (maximum 2ml per session) into the base of warts, every 2 weeks for 4-6 sessions for a duration of 4 months. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with cutaneous warts and willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women, Immunosuppresed, Allergic to vitamin D3. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with complete clinical clearance of all treated cutaneous warts tend of treatment. |
Baseline (week 0); treatment visits (week 0,2,4,8,10) end of treatment assessment at week 12, follow up at week 24. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| response at 12 weeks, mean % reduction in wart number and size, time to complete clearance (weeks), recurrence rate at 24 weeks, injection pain (VAS). |
Baseline (week 0); treatment visits (week 0,2,4,8,10) end of treatment assessment at week 12, follow up at week 24. |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0"
Months="10"
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 - NO
|
|
Brief Summary
|
THIS IS AN OPEN LABEL SINGLE ARM PHASE 4 INTERVENTIONAL STUDY CONDUCTED AT THE DEPARTMENT OF DERMATOLOGY JJM MEDICAL COLLEGE DAVANGERE TO EVALUATE THE EFFECTIVENESS AND SAFETY OF INTRALESIONAL VITAMIN D3 FOR TREATMENT OF CUTANEOUS WARTS ELIGIBLE PATIENTS WILL RECEIVE VITAMIN D3 600000 IU EVERY 2 WEEKS FOR UPTO 6 SESSIONS THE PRIMARY ENDPOINT IS THE COMPLETE CLINICAL CLEARANCE OF TREATED WARTS AT 12 WEEKS |