| CTRI Number |
CTRI/2024/11/076957 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between tofacitinib ointment with betamethasone valerate cream on skin of vitiligo patient |
|
Scientific Title of Study
|
Evaluate Efficacy and safety of 2 percent topical tofacitinib versus 0.05 percent topical betamethasone valerate in treatment of vitiligo among patients attending tertiary care hospital bhavnagar a simple randomized controlled study |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr nirbhay damor |
| Designation |
1st year resident |
| Affiliation |
Government medical college,bhavnagar |
| Address |
Room no 115, skin department OPD,sir t hospital,jail road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9737407197 |
| Fax |
|
| Email |
nirbhaydamor97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr hita mehta |
| Designation |
Professor and head of department of DVL |
| Affiliation |
Government medical college,bhavnagar |
| Address |
Room no 115, skin department OPD,sir t hospital,jail road, bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429503188 |
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NIRBHAY DAMOR |
| Designation |
1st year resident |
| Affiliation |
Government medical college,bhavnagar |
| Address |
Room no 115, skin department OPD,sir t hospital,jail road, bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9737407197 |
| Fax |
|
| Email |
nirbhaydamor97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No 115, Skin Department OPD,Sir T hospital,Jail Road, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
DR NIRBHAY DAMOR |
| Address |
Room No 115, Skin Department OPD,Sir T hospital,Jail Road, Bhavnagar
|
| 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 |
| Dr nirbhay damor |
Sir t hospital,bhavnagar |
Room no 115, skin department OPD,sir t hospital,jail road, bhavnagar
Bhavnagar
GUJARAT |
9737407197
nirbhaydamor97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE,BHAVNAGAR |
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 |
0.05% topical betamethasone valerate cream |
Local application twice a day for 2 months |
| Intervention |
2% topical tofacitinib ointment |
Local application twice a day for 2 months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age more than 2 yrs of either gender presenting with less than five depigmented patches with size not exceeding 10 × 10 CM |
|
| ExclusionCriteria |
| Details |
Patient of vitiligo who have taken treatment in past 3 months.
Patient of vitiligo with any other dermatology disorder.
Patient of vitiligo with site involving mucosal, genital, perianal regions and face lesion |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE VASI(vitiligo area scoring index) |
outcome will be assessed at baseline,1 month,2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitiligo Noticeability Scale (VNS) and Percentage repigmentation |
2 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/11/2024 |
| 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="3"
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
|
Evaluate Efficacy and safety of topical tofacitinib
versus topical betamethasone in treatment of vitiligo among patients attending
tertiary care hospital bhavnagar- a Simple randomized controlled,
study
Aim : To assess efficacy
of 2% topical tofacitinib ointment With 0.05% topical betamethasone valerate
cream in terms of VASI ,VNS and Percentage repigmentation in
treatment of vitiligo.
Objective :
Primary:
1.To
compare the efficacy of 2% topical tofacitinib ointment with 0.05% topical
betamethasone valerate in treatment of vitiligo using vitiligo area scoring
index (VASI) and Vitiligo Noticeability Scale (VNS).
2. To
assess the side effects of 2% topical tofacitinib ointment in
treatment of vitiligo.
3. To
assess the side effects of 0.05% topical betamethasone cream in treatment of
vitiligo.
METHODOlOGY
-Permission of ethics
committee and CTRI will be taken
-Clinically diagnosed patients
of vitiligo will be assessed for eligibility and will be included according to
inclusion and exclusion criteria in the study after the consent is given
-Relevant history of the
patient will be taken with the help of data collection tool
-Patient will be randomized
into group A and group B
With Simple
randomization method,vitiligo area scoring index(VASI)
will be calculated
(BASELINE,1MONTH,2MONTH)
-Group A- 2% Topical
tofacitinib ointment local application twice a day for 2 months
Group B- 0.05% Topical
betamethasone valerate cream local application twice a day for 2 months
Vitiligo Noticeability Scale
(VNS) and Percentage repigmentation will be evaluated)
-Data will be collected and
entered in excel sheet.
Appropriate statistical test
will be applied and analysis will be done. |