| CTRI Number |
CTRI/2024/06/069125 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effects of oral tofacitinib plus oral puvasol with oral corticosteroids plus oral puvasol in vitiligo patients and also study the side effects of bothe drugs |
|
Scientific Title of Study
|
TO STUDY AND COMPARE THE EFFECTIVENESS OF ORAL TOFACITINIB PLUS ORAL PUVASOL VS ORAL CORTICOSTEROIDS PLUS ORAL PUVASOL IN VITILIGO - A RANDOMIZED CONTROL TRIAL. |
| Trial Acronym |
NO TRIAL ACRONYM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUPRIYA BEHERA |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK |
| Address |
DEPARTMENT OF DERMATOLOGY, SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK, ODISHA - 753007
Cuttack
ORISSA
753007
India |
| Phone |
7873144124 |
| Fax |
|
| Email |
beherasupriya89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. PRASENJEET MOHANTY |
| Designation |
DEAN AND PRINCIPAL |
| Affiliation |
SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK |
| Address |
DERMATOLOGY DEPARTMENT, SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK, ODISHA - 753007
ORISSA
753007
India |
| Phone |
7873144124 |
| Fax |
|
| Email |
titoon@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUPRIYA BEHERA |
| Designation |
POSTGRADUATE RESIDENT |
| Affiliation |
SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK |
| Address |
DERMATOLOGY DEPARTMENT, SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK, ODISHA - 753007
ORISSA
753007
India |
| Phone |
7873144124 |
| Fax |
|
| Email |
beherasupriya89@gmail.com |
|
|
Source of Monetary or Material Support
|
| SCB MEDICAL COLLEGE, CUTTACK, ODISHA |
|
|
Primary Sponsor
|
| Name |
SUPRIYA BEHERA |
| Address |
SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK , ODISHA |
| 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 SUPRIYA BEHERA |
SCB MEDICAL COLLEGE AND HOSPITAL CUTTACK, ODISHA |
CUTTACK, ODISHA - 753007
Cuttack
ORISSA |
7873144124
beherasupriya89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SCB MEDICAL COLLEGE AND HOSPITAL CUTTACK |
Approved |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ORAL CORTICOSTEROIDS AND ORAL ORAL PUVASOL |
THIS IS CONVENTIONAL AGENT OF TREATMENT IN VITILIGO WITH A REPIGMENTATING AGENT.
ORAL BETAMETHASONE 0.03MG PER KG BODY WEIGHT FOR 2 DAYS PER WEEK FOR 24 WEEKS ALONG WITH ORAL PUVASOL IE TAB METHOXSALEN 10 MG ON ALTERNATE DAYS FOR 24 WEEKS AS WELL |
| Intervention |
TOFACITINIB PLUS ORAL PUVASOL |
THIS IS THE NEW DRUG WHICH HAS BEEN ALREADY USED IN TREATMENT OF VITILIGO BUT COMPARATIVE STUDIES ARE NOT AVAILABLE.
TAB TOFACITINIB 5 MG BD FOR 6 MONTHS ALONG WITH TAB METHOXSALEN 10 MG ALTERNATE DAYS FOR 6 MONTHS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years
2. Body surface area less than 80%
3. Progressive disease( peak of incidence within 6 months ) |
|
| ExclusionCriteria |
| Details |
1. Universal vitiligo
2. Pregnant and lactating women
3. Patients undergoing immunosuppressive therapy
4. Patients of leukoderma due to other causes
5. Patients having photosensitivity
6. Patients having malignancy or undergone radiotherapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Repigmentation in test (18 patients ) and control group (18 patients ) comparing with VASI score at 12 and 24 weeks. |
12 and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Study the side effects of drugs in both the test & control group |
12 & 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/07/2024 |
| 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="0"
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
|
This is a open label randomized controlled trial with sample size of 36, 18 in test group and 18 in control group. Sample size is calculated using superiority trial method. The subjects will be ramdomized using compurter based radmond application and test group will be given oral tofacitinib plus oral puvasol and control group will be given oral corticosteroids plus oral puvasol. Repigmentation in the form of VASI score will be compared at 12 weeks and 24 weeks. The additional side effects in the form of secondary outcome will be seen as well. |