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CTRI Number  CTRI/2025/01/079688 [Registered on: 29/01/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare efficacy of topical 2 percent tofacitinib ointment versus 0.1 percent tacrolimus ointment in patients of vitiligo 
Scientific Title of Study   Efficacy of 2 percent Tofacitinib ointment versus 0.1 percent Tacrolimus ointment in patients of vitiligo - A hospital based double blinded randomised controlled trial 
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 Kavita Swami 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Gorakhpur  
Address  Department of dermatology, 2nd floor, hospital block, AIIMS Gorakhpur, Kunraghat, UP, India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9588058209  
Fax    
Email  drderma321@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shiwangi Rana 
Designation  Assistant Proffesor  
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of dermatology, 2nd floor, hospital block, AIIMS Gorakhpur, Kunraghat, UP, India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  8860565443  
Fax    
Email  shivangi.rana356@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kavita Swami 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Gorakhpur 
Address  Department of Dermatology and Venereology, 2nd floor, Hospital block, AIIMS Gorakhpur, Kunraghat, Uttar Pradesh, India

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9588058209  
Fax    
Email  drderma321@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Gorakhpur 
Principal investigator 
 
Primary Sponsor  
Name  Dr Kavita Swami 
Address  Department of Dermatology, 2nd floor, Hospital block, AIIMS Gorakhpur, Kunraghat, Uttar Pradesh, India, 273008 
Type of Sponsor  Other [Self] 
 
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 Kavita Swami  All India Institute of Medical Sciences, Gorakhpur   Room number 227, Department of Dermatology, 2nd floor, hospital block, AIIMS Gorakhpur, Kunraghat, Gorakhpur, UP
Gorakhpur
UTTAR PRADESH 		 9588058209

drderma321@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee All India Institute of Medical Sciences, Gorakhpur, India - 273008  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  Tacrolimus   Patients in other group will be applying 1 finger tip unit of Tacrolimus 0.1 percent ointment topically over vitiligo lesions for atotal duration of 24 weeks once daily during the daytime for initial 8 weeks followed by twice daily for next 16 weeks and momatasone furoate 0.1 percent cream for a total of 8 weeks once daily during nighttime for initial 4 weeks followed by alternate night application over next 4 weeks. 
Intervention  Tofacitinib   Patients in one group will be applying 1 finger tip unit of Tofacitinib 2 percent ointment topically over vitiligo lesions for a total duration of 24 weeks once daily during the daytime for initial 8 weeks followed by twice daily for next 16 weeks along with momatasone furoate 0.1 percent cream for a total duration of 8 weeks once daily during nighttime for first 4 weeks followed by alternate night application over next 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  vitiligo patients with affected total body surface area less than 5 percent, who are equal to or older than 18 years of age not taking any systemic treatment from past 3 months 
 
ExclusionCriteria 
Details  vitiligo patients who have only mucosal involvement, or TBSA more than 5 percent, or those requiring systemic treatment, or pregnancy or lactation, or younger than 18 years of age, or having known hypersensitivity to momatasone cream, tacrolimus ointment or tofacitinib ointment not consenting to the study  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Number and percentage of patients achieving treatment success which is defined by Vitiligo noticebility scale grade more than 3 or more than 50% repigmentation in vitiligo patch in both groups after 24 weeks of treatment.
 		 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number and percentage of patients achieving treatment success which is Vitiligo noticebility scale grade more than or equal to 3 or more than 50% repigmentation as per various types of vitiligo at the end of 24 weeks.

2. Number and percentage of patients who had any improvement in leukotrichia.

3. Number of patients achieving treatment success which is Vitiligo noticebility scale grade more than or equal to 3 or more than 50% repigmentation in acral and non acral vitiligo in both groups at the end of study. 		 24 weeks 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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 3 
Date of First Enrollment (India)   11/02/2025 
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="6"
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 study recruits a total of 84 patients willing to participate in the study after taking written informed consent and divides them into two groups each having a total of 42 participants randomly. One group will be recieving topical 2% tofacitinib ointment + momatasone cream( standard therapy for vitiligo) for 8 weeks followed by only tofacitinib ointment application twice daily for the next 16 weeks. Similarly other group will be applying 0.1 % tacrolimus in place of tofacitinib initialy once daily for 8 weeks followed by twice daily for next 16 weeks. Each participant will be followed up regularly at 4 weeks interval for clinical assesment which will be recorded and to note adverse effect if any to given therapy. At the end of 24 weeks outcomes will be compared in terms of number and percentage of patients achieving treatment success using  vitiligo noticebility scale( patient based score) and percentage repigmentation( physician based score) in each group.
Randomization will be done by using a randomization chart generated by a medical personal outside of the department of dermatology and venereology who will be alloting the patients into either group based on the number given to each patient in the sequence of their enrollement into the study. This person will be distributing medication to each patient on the basis of the randomization chart at a regular interval of 4 weeks in the form of packed tubes labeled as A,B OR C  and only this person will be aware of the content of each tube keeping the patient and the investigator blinded.
 
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