| CTRI Number |
CTRI/2025/02/080526 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the safety and efficacy of oral tofacitinib ans oral azathioprine in unstable vitiligo |
|
Scientific Title of Study
|
A comparative study to evaluate the safety and efficacy of oral tofacitinib and oral azathioprine in unstable vitiligo:A one year hospital based randomised control trial at a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Acharya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belgavi |
| Address |
OPD 23, KLE Dr. Prabhakar kore hospital, Department of Dermatology,Venereology and leprosy,Jawaharlal Nehru Medical College ,Belgavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8970161543 |
| Fax |
|
| Email |
aishwaryaacharya1398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavana Doshi |
| Designation |
Head of Department,Dermatology, Venereology and leprosy |
| Affiliation |
Jawaharlal Nehru Medical College, Belgavi-590010 |
| Address |
OPD 23,1st floor,KLE dr Prabhakar kore hospital, Department of Dermatology, Venereology,Leprosy, Jawaharlal Nehru Medical College, Belgavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9422306523 |
| Fax |
|
| Email |
bhavs1982@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Acharya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belgavi-590010 |
| Address |
Department of Dermatology, Venereology,Leprosy, Jawaharlal Nehru Medical College, Belgavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08970161543 |
| Fax |
|
| Email |
aishwaryaacharya1398@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Acharya |
| Address |
Department of Dermatology, Venereology,Leprosy, Jawaharlal Nehru Medical College, Belgavi-590010 |
| 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 Aishwarya Acharya |
KLEs Dr. Prabhakar Kore hospital |
OPD 23 , 1st Floor , dermatology , venereology and leprosy department, KLEs Dr. Prabhakar Kore hospital, belagavi-590010
Belgaum
KARNATAKA |
8970161543
aishwaryaacharya1398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NMC Institutional Ethics committee |
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 azathioprine (Group B) |
Patients in group B will be given oral azathioprine 50 mg twice daily for 12 weeks. |
| Intervention |
oral drugs |
oral drugs i.e. oral tofacitinib and oral azathioprine will be given in group A and B respectively for 12 weeks |
| Comparator Agent |
Oral tofacitinib(Group A ) |
Patients of Group A will be given oral tofacitinib 5mg BD daily for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with clinical signs of unstable vitiligo
2.Patients who have not taken any systemic treatment in last 1 month , topical treatment in last 2 weeks and excimer laser in last 8 weeks
3. When body surface area more than 10% involved
5.Patient willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Patient with exclusive segmental and mucosal vitiligo
2. Pregnancy and lactation
3. Patients with active TB infection or any contact with TB patient
4. Patients with chronic liver disease , cirrhosis, HIV/AIDS, renal dysfunction , malignancies
5.Patients on drugs interacting with azathioprine / tofacitinib
6.Patient with history of hypersensitivity to tofacitinib / azathioprine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of oral tofacitinib and oral azathioprine in unstable vitiligo |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of oral tofacitinib & oral azathioprine in unstable vitiligo |
One year |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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 2 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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 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
|
All patients diagnosed with unstable non-segmental vitiligo aged 18-60 years attending dermatology out patient department at KLE’s Dr. Prabhakar Kore hospital and MRC, Belagavi will be recruited after taking written informed consent. All patients in study will undergo a detailed history taking, general physical, systemic and dermatological examination. Data will be collected by a single examiner and recorded in case record proforma. The treatment plan will be discussed with patients, along with the anticipated outcomes, length of treatment, follow-ups, side effects to be reported, and treatment prognosis. Patients will be randomly divided into two equal groups, namely Group A and Group B. Complete hemogram, liver function test, Renal function test, Lipid profile, Hepatitis B, Hepatitis C, Mantoux test will be done at Baseline. Patients of Group A will be given oral tofacitinib 5mg BD daily and those of the Group B will be given oral azathioprine 50 mg twice daily. Complete hemogram, liver function test, Renal function test , Lipid profile repeated monthly once for the rest 3 months .
Digital photographs will be taken using identical camera settings, patient positioning and room lighting at baseline and at every followup. The treatment duration in both groups is 3 months with follow-up at 1st month , 2nd month and 3rd month. Digital photographs will be taken at each visit. Side effects if any will be noted at each follow up. After 3 months, the digital photographs will be compared with baseline. Patient’s assessment of improvement will be recorded by visual analog scale. Physician’s assessment of improvement will also be recorded by VASI. The efficacy of the treatment will be calculated based on percent of regimentation. The safety of the treatment will be assessed by the side effects associated with the treatment.
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