| CTRI Number |
CTRI/2019/07/020453 [Registered on: 30/07/2019] Trial Registered Prospectively |
| Last Modified On: |
29/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Vitamin D3 injection in warts. |
|
Scientific Title of Study
|
Intralesional Vitamin D3 - An Immunotherapy in cutaneous warts. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSNageswaramma |
| Designation |
Professor and HOD |
| Affiliation |
Guntur medical college |
| Address |
Depatment of DVL,Government general hospital,guntur
Guntur
ANDHRA PRADESH
522001
India |
| Phone |
|
| Fax |
|
| Email |
ravindranag1960@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajitha alluri |
| Designation |
Post graduate |
| Affiliation |
Guntur medical college |
| Address |
Depatment of DVL,Government general hospital,Guntur
Guntur
ANDHRA PRADESH
522001
India |
| Phone |
|
| Fax |
|
| Email |
dr.rajithaalluri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajitha alluri |
| Designation |
Post graduate |
| Affiliation |
Guntur medical college |
| Address |
Depatment of DVL,Government general hospital,Guntur
Guntur
ANDHRA PRADESH
522001
India |
| Phone |
|
| Fax |
|
| Email |
dr.rajithaalluri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.rajitha alluri,Government general hospital,guntur. |
|
|
Primary Sponsor
|
| Name |
DrRajitha alluri |
| Address |
Department of DVL,OP number-30, Government general hospital, Guntur. |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrRajitha alluri |
Government general hospital |
Depatment of DVL,OP number-30,opposite guntur railway station,Guntur-522001
Guntur
ANDHRA PRADESH |
9490890950
dr.rajithaalluri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instititional Ethics Committee -GUNTUR MEDICAL COLLEGE AND GOVT.GENERAL HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
cutaneous warts |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intralesional vitamin D3-An Immunotherapy in cutaneous warts. |
0.2 ml of 6,00,000 IU Vitamin D3 was injected to the base of warts after injecting with 0.2 ml lignocaine.The injections were repeated 2 weekly for a
maximum of 4 sessions or until complete clearance. A maximum of 2 warts were treated per session and the patients were followed up for 6 months. |
| Comparator Agent |
None |
None |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with cutaneous warts
2.patients aged 15-60 years
3.Patients with no other treatment modalities in the past 3 months
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating females
2.Immunosupression including HIV
3.Any local or systemic inflammation or infection
4.Past history of meningitis o convulsions
5.plane warts
6.Genital warts
7.Patients with keloidal tendency.
8.Prior history of hypersensitivity to Vitamin
D3
9.Previously diagnosed renal disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clearance of cutaneous warts at both primary and distant sites. |
2,4,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Adverse effects of
vitamin D3 injection.
2.Recuurence of cutaneous
warts in patients treated
with vitamin D3. |
1. 8 Weeks
2. 6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2019 |
| Date of Study Completion (India) |
05/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
cutaneous warts are usually treated by destructive modalities but these are associated with scarring and frequent recurrences and are not useful for treatment of multiple warts.This is an non-randomized,open label, interventional study to evaluate the safety and efficacy of intralesional vitamin D3 in cutaneous warts.0.2 ml of vit D3 was injected into the base of each wart.The injections were repeated 2weekly for a Maximum of 4sessions or until complete clearance. A Maximum of 2 warts were treated per session and the primary outcome was evaluated by the clearance of both local and distant warts.The secondary outcome was evaluated by the recurrence of warts after a follow-up period of 6months. |