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CTRI Number  CTRI/2023/12/060431 [Registered on: 01/12/2023] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Tofacitinib and Tacrolimus Creams for Unstable Vitiligo Treatment 
Scientific Title of Study   A randomized study to compare the efficacy of topical tofacitinib versus topical tacrolimus in treatment of patients with unstable vitiligo 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Davinder Parsad 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7986359284  
Fax    
Email  parsad@mac.com  
 
Details of Contact Person
Scientific Query
 
Name  Davinder Parsad 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh


CHANDIGARH
160012
India 
Phone  7986359284  
Fax    
Email  parsad@mac.com  
 
Details of Contact Person
Public Query
 
Name  Davinder Parsad 
Designation  Professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Room no 8 Level 2 Block F Nehru Hospital Post Graduate Institute of Medical Education and Research Sector 12 Chandigarh


CHANDIGARH
160012
India 
Phone  7986359284  
Fax    
Email  parsad@mac.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Sector 12 Chandigarh 160012 
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 Davinder Parsad  Post Graduate Institute of Medical Education and Research, Chandigarh  Room no 5009, Block C, Level 5, New OPD, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH 
7986359284

parsad@mac.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Topical Tacrolimus 0.1% ointment  Topical Tacrolimus 0.1% ointment applied to vitiligo patches twice a day for 16 weeks 
Intervention  Topical Tofacitinib 2% ointment  Topical tofacitinib 2% ointment applied to vitiligo patches twice a day for 16 weeks 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Consecutive patients with clinical diagnosis of vitiligo vulgaris and fulfilling the inclusion criteria listed below will be recruited for the study.
1. Participants aged 5 years and over with a diagnosis of non-segmental vitiligo, limited to approximately 10% or less of body surface area
2. At least two symmetrical vitiligo patches that have been active in the last 12 months (reported by the participant, or parent).
3. Participants should be willing to stop any other active therapies for their vitiligo at time of randomisation, be able to administer the treatments safely at home (able to follow the treatment instructions and children able to comply with the necessary precautions).
4. Participants also need to be willing and able to give informed consent (or parental/guardian consent in the case of children).
 
 
ExclusionCriteria 
Details  1. Potential participants with segmental or universal vitiligo, vitiligo limited to areas contraindicated for treatment with potent topical corticosteroid (e.g., around the genitals)
2. Evidence of marked Koebner phenomenon (lesions appearing in sites of skin trauma) as such potential participants are likely to require urgent care.

3. Participants with a history of skin cancer, radiotherapy use or photosensitivity;
4. Women who are pregnant, breastfeeding or likely to become pregnant during the treatment period;
5. Those currently using immunosuppressive drugs, or involved in another clinical trial and those with allergy or contraindication to any of the drugs.
6. Potential participants are not randomised into the trial if the investigator feels that they are unable to follow the treatment instructions, or if children are unable to comply with the necessary safety precautions.
Patients receiving topical or systemic therapy of any form for vitiligo will be kept off treatment for 2 weeks prior to start of therapy (as a wash out period).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients reporting that their vitiligo is either ‘a lot less noticeable’ or ‘no longer noticeable’ in response to the question: ‘Compared with the start of the study, how noticeable is the vitiligo now? using the validated Vitiligo Noticeability Scale (VNS).   16 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Onset of treatment response: assessed by participant & investigator for each patch of vitiligo. The question ‘Compared with the start of the study, has there been a change in the vitiligo patch?’ is asked, with the patient & investigator responding with one of the following: stayed the same, improved, got worse.  week 4, week 8, week 12 & week 16 
Repigmentation in each topographical area will be assessed by using Vitiligo Area Scoring Index (VASI) at every visit  week 4, week 8, week 12 & week 16 
Colour-match of Repigmentation: Somewhat Darker/Somewhat Lighter/Same
 
week 4, week 8, week 12 & week 16 
Pattern of repigmentation: Diffuse/Peri-follicular/Peripheral/Combined
 
week 4, week 8, week 12 & week 16 
Incidence of adverse effects  week 4, week 8, week 12 & week 16 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) 31/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Vitiligo is the commonest depigmenting skin disorder affecting people of all skin types and ethnicities. It is characterized by a selective and progressive loss of functioning melanocytes from epidermis resulting in white patches on the skin and occasionally mucosae as well. A number of treatment approaches have been tried but none of them has been universally accepted as the therapy of choice. Currently there is no cure or effective method to limit the spread of the disease. The topical calcineurin inhibitors tacrolimus (0.03% in children and 0.1% in adults) and pimecrolimus 1% are preferred to topical corticosteroids for patients with limited vitiligo involving the face or areas at high risk for skin atrophy (e.g., intertriginous areas, genitals). Individual case reports describing the efficacy and safety of topical JAKi including topical tofacitinib, topical ruxolitinib and topical brepocitinib are available. These have been tried in cases of segmental as well as non-segmental vitiligo. While topical tofacitinib and ruxolitinib had favorable outcomes, topical delgocitinib showed variable results. Most of the studies on topical JAKi in vitiligo are open label, uncontrolled studies in whom treatment has been tried in combination with other therapies. Larger randomized trials are needed to conclusively establish role of topical JAKi in management of vitiligo.

 In this prospective randomised study, we intend to evaluate the efficacy and tolerability of topical tofacitinib and compare it with topical tacrolimus in 25 patients (50 patches) of limited vitiligo vulgaris with an actively spreading disease and satisfying other inclusion criterias.

 
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