| CTRI Number |
CTRI/2024/12/077629 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Inj Vitamin D versus Inj Acyclovir to find which drug is better to treat warts which do not resolve with other treatment options. |
|
Scientific Title of Study
|
Evaluation of efficacy of intralesional Inj. Vitamin D versus intralesional Inj. Acyclovir in the treatment of recalcitrant cutaneous warts: A randomised clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashrita Krishna |
| Designation |
Post graduate student |
| Affiliation |
Hassan Institute Of Medical Sciences |
| Address |
Hassan institute of medical sciences,Department of Dermatology,Venereology and Leprosy,Hassan - 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9632221374 |
| Fax |
|
| Email |
ashrita.kr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Suresh M R |
| Designation |
Associate Professor |
| Affiliation |
Hassan Institute Of Medical Sciences |
| Address |
Hassan institute of medical sciences,Department of Dermatology,Venereology and Leprosy, room no 14, Hassan - 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9632221374 |
| Fax |
|
| Email |
drsureshhsn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashrita Krishna |
| Designation |
Post graduate student |
| Affiliation |
Hassan Institute Of Medical Sciences |
| Address |
Hassan institute of medical sciences, Department of Dermatology,Venereology and Leprosy,Hassan - 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9632221374 |
| Fax |
|
| Email |
ashrita.kr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hassan Institute Of Medical Sciences,Hassan 573201, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
Ashrita Krishna |
| Address |
Hassan Institute Of Medical Sciences ,Hassan 573201 |
| 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 |
| Ashrita Krishna |
Hassan institute of medical sciences |
Department of Dermatology, Venereology, and Leprosy, room no-14A,Hassan - 573201
Hassan
KARNATAKA |
09632221374
ashrita.kr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Etthics Committee-HIMS HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Acyclovir |
Intralesional injection of acyclovir (70 mg/ml), at a dose of 0.1 ml, injected into the base of each wart.
|
| Intervention |
Inj Vitamin D |
Inj Vitamin D3 (0.2mL, 15mg/dl) injected into the base of the warts after injecting with lidocaine (0.2mL, 15mg/dl) |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 or more recalcitrant warts (defined here as warts persistent for a period of more than 6 months, resistant to at least 2 conventional treatment modalities)
Extragenital warts.
Patients willing to give informed written consent for the study.
|
|
| ExclusionCriteria |
| Details |
Mucosal warts,
Pregnancy, lactation, Immunosuppression |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Achieving Visual analogue score 4 |
week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue score 4 |
week 2,4,6 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
14/12/2024 |
| 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="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
|
Patients with cutaneous warts attending the Outpatient Department of Dermatology were enrolled after obtaining informed written consent with complete history taking and thorough cutaneous examination
Clinico‑demographic details of participants were recorded and clinical, images were taken at baseline and at each follow‑up visit i.e at 2nd ,4th ,6th, and 8th week .
All patients fulfilling the inclusion criteria will be categorized into two groups depending on the treatment they received, namely, Group A (intralesional Vit D) and Group B (intralesional acyclovir) (n=20 per group ) 1 Group A : Vitamin D3 (0.2mL, 15mg/dl) injected into the base of the warts after injecting with lidocaine (0.2mL, 15mg/dl).
Group B : Intralesional injection of acyclovir (70 mg/ml), at a dose of 0.1 ml, injected into the base of each wart.
Repeated two weeks apart for a maximum of four sessions or until complete clearance, whichever occureds earlier. Patients were further followed up for a period of 6 months after treatment completion. Clinical response documented by recording the decrease in number and size of lesions at each visit i.e., at 2 weekly intervals for 4 sessions and 3 months after the last injection. The reduction in the size and number of warts classified the response to treatment into four grades based on the Visual Analogue Scale (VAS) score
|