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CTRI Number  CTRI/2024/04/065014 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 30/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A trial for comparing efficacy and safety of oral corticosteriod mini pulse versus oral tofacitinib in arresting disease progression and repigmentation of active vitiligo 
Scientific Title of Study   Comparison of efficacy and safety of oral corticosteriod mini pulse versus oral tofacitinib in stabilization and repigmentation of active vitiligo: A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saurabh Singh 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Room No. 3139, Third floor, College Building, All India Institute of Medical Sciences, Basni Industrial Area Phase-2, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9968024250  
Fax    
Email  saurabhdoc@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Saurabh Singh 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Jodhpur 
Address  Room No. 3139, Third floor, College Building, All India Institute of Medical Sciences, Basni Industrial Area Phase-2, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9968024250  
Fax    
Email  saurabhdoc@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Prajakta Waghmare 
Designation  Post Graduate Student 
Affiliation   
Address  Room No. 112, Department of Dermatology, AIIMS OPD Block A, First Floor, AIIMS Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9421148630  
Fax    
Email  drprw98@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur 
 
Primary Sponsor  
Name  Research Cell, AIIMS Jodhpur 
Address  All India Institute of Medical Sciences, Basni Industrial Area Phase-2, Jodhpur, 342005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saurabh Singh  All India Institute of Medical Sciences, Jodhpur  Room No. 107, Department of Dermatology, OPD Block A, First floor, AIIMS Jodhpur
Jodhpur
RAJASTHAN 		 9968024250

saurabhdoc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral corticosteroid mini pulse  Oral corticosteroid mini pulse 5 mg on 2 days per week followed by tapering after disease stabilization.  
Intervention  Oral tofacitinib  Oral tofacitinib 5 mg OD for 2 weeks followed by 5 mg BD till disease stabilization followed by tapering. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  All consecutive patients with body weight >35 kg and age < 50 years, of either gender who are willing to participate and fulfill the following eligibility criteria for active vitiligo:
1.Subjects with non-segmental, unstable vitiligo with body surface area involved >2%
2.Disease activity in the past 3 months –

a.New lesions
b.Increase in the size of the older lesions
c.Depigmentation of previously repigmented lesions  
 
ExclusionCriteria 
Details  Patient having any of the following criteria will be excluded from the study.
1.Segmental vitiligo
2.Pregnancy or lactation
3.Presence of any of the following: immunocompromised host, malignancy, co-morbidities like uncontrolled diabetes, renal disease, hepatitis.
4.Any known contraindication or hypersensitivity to any of the study molecules. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
A.Arrest of disease progression (clinical and dermoscopic assessment)
1. No new lesions.
2. No increase in the size of the older lesions.
3. No depigmentation of previously repigmented lesions

B.Improvement in the vitiligo signs of activity score37 (VSAS) score from baseline. 		 2, 4, 8, 12, 16, 20, 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
A.Repigmentation :
a. Objective - Investor global assessmen39 (IGA) and Vitiligo area scoring41(VASI)
b. Subjective - Patient global assessment (PGA) on a scale of 0 to 10 39
B.Side effects will be noted
C.Improvement in the Vitiligo Impact Scale 2240 (VIS-22)
D.Serum IL-6 levels42 		 1. VIS at baseline and 24 weeks
2. IL-6 levels at baseline and 24 weeks 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   02/05/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Recruitment yet to commence
By this trial we would compare efficacy and safety of oral corticosteroid mini pulse versus oral tofacitinib in stabilization and repigmentation of active vitiligo
Trial not yet started
PROCEDURE: 
After informed written consent, Patients will be enrolled in the study based on the inclusion criteria and exclusion criteria. The patients demographic details, disease duration, sites of involvement and previous treatment history, clinical examination will be recorded. Morphology and distribution of vitiligo lesions will be documented in the body chart. Patients will be evaluated for vitiligo skins lesions. Baseline investigations like CBC, KFT, LFT, CHEST XRAY, plasma glucose fasting , glycosylated haemoglobin, ECG, urine R/M, fasting lipid profile, UPT(in females), screening for HIV, hepatitis B and C and  serum IL6 levels will be done.
Dermoscopy findings will be recorded on representative vitiligo lesion. Patient will be asked to fill the Dermatology life quality index (VIS 22). VASI will be calculated. Patient who fulfilled the selection criteria will be randomly allocated to one of the two groups for a treatment duration of 24 weeks.
GROUP A - Patients will receive OMP 5 mg on 2 consecutive days/week for 16 weeks or till VIDA score of 3+, whichever is earlier. To be tapered till total duration of 24 weeks. Tapering shall not be done if arrest of disease progression is not achieved. Oral calcium-vitamin D3 supplementation shall be advised. Symptomatic treatment for any other side effects shall be done. GROUP B - Patients will receive tofacitinib 5 mg OD for 2 weeks followed by 5 mg BD for 14 weeks or till VIDA score of 3+, whichever is earlier. To be tapered till total duration of 24 weeks. Tapering shall not be done if arrest of disease progression is not achieved. Symptomatic treatment for any other side effects shall be done. 
Serum IL-6 levels shall be done in all patients at baseline as well as post treatment, that is, at 24 weeks. A group of stable vitiligo patients (no disease activity for past >3 months) shall be recruited as controls for serum IL-6 estimation. 
FOLLOW UP
First follow up at 2 week and then every 4 weekly. Plan to taper the therapy if disease arrest of disease progression for 1 month, otherwise same dose shall be continued.
Blood investigations will be group specific and shall be repeated as follows:
Group A – Fasting blood sugar at 0,4 and 24 weeks (any other time frame if abnormal). HbA1c at 0 and 24 weeks.
Group B – CBC at 0,2,4,12 and 24 weeks (any other time frame if abnormal). Fasting lipid profile at 0,4 and 24 (any other time frame if abnormal). LFT at 0,4,12 and 24 weeks. 
Follow up visits – 
Clinical examination, clinical photography, dermoscopy: 4 weekly
Investor global assessment (IGA)/ Vitiligo area scoring index (VASI) 4 weekly
Patient global assessment(PGA): 4 weekly                                                                                             
Vitiligo disease activity score (VIDA): 12 ,16 and 24 weeks 
Serum IL6 levels : 0 and 24 weeks
 
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