| CTRI Number |
CTRI/2019/04/018822 [Registered on: 29/04/2019] Trial Registered Prospectively |
| Last Modified On: |
25/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see the efficacy of injection vitamin D3 given into the skin warts. |
|
Scientific Title of Study
|
Therapeutic efficacy of intralesional vitamin D3 in verruca vulgaris. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surbhi Jain |
| Designation |
Post graduate junior resident |
| Affiliation |
Government Medical College and Hospital, sector 32 chandigarh |
| Address |
Department of Dermatology
5th floor , D block
Government Medical College and Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9478188115 |
| Fax |
|
| Email |
jain.shubh93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Gurvinder Pal Thami |
| Designation |
Professor And Head of Department |
| Affiliation |
Government Medical College and Hospital , sector 32 Chandigarh |
| Address |
Department of Dermatology
5th floor, D block
Government Medical College and Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
thamigp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surbhi Jain |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital , sector 32 Chandigarh |
| Address |
Department of Dermatology
5th floor, D block
Government Medical College and Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
|
| Fax |
|
| Email |
jain.shubh93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology |
| Address |
Government Medical College and Hospital
Sector 32
Chandigarh
Pin code 160030 |
| Type of Sponsor |
Government 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 Surbhi Jain |
Government Medical College and Hospital |
Dermatology , Venereology and Leprosy OPD
4th floor, B block
Chandigarh
CHANDIGARH |
9478188115
jain.shubh93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 Vitamin D3 |
0.2 ml (1,20,000 IU ) vitamin D3 solution will be slowly injected into the base of each wart. A maximum of 5 warts will be injected per session amounting to total dose of 1ml -6,00,000 IU (15mg/ml) of vitamin D3 in one treatment session . A total of four such weekly sessions shall be instituted with injection being given in same 5 lesions selected earlier. Patients will be investigated for serum vitamin D levels before and after therapy. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All untreated consecutive patients of verruca vulgaris.
2. Above the age of 14 years. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating females.
2. Any evidence of immunosuppression including HIV .
3. With a prior history of hypersensitivity to Vitamin D.
4. History of intake of vitamin D3, anabolic steroids or bisphosphonates in the last 3 months.
5. Patients having any significant systemic illness.
6. Patients having pre procedure serum vitamin D levels >100 ng/ml. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of intralesional vitamin D3 in verruca vulgaris |
0,1,2,3,8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects of intralesional vitamin D3 in patients of verruca vulgaris. |
0,1,2,3,8 weeks |
| Recurrence rate of verruca vulgaris treated with intralesional vitamin D3 |
8 weeks |
|
|
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)
|
01/06/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Verruca vulgaris is caused by different serotypes of HPV and various treatment modalities are available including topical therapies, immunotherapy and surgical options. This is prospective interventional study to know the efficacy of intralesional vitamin D3 in verruca vulgaris which is the primary outcome. Secondary outcomes include to study the adverse effects and recurrence rates. |