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CTRI Number  CTRI/2025/03/083363 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 24/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to evaluate the effect and safety of Topical Tacrolimus and Topical Tofacitinib ointments for treatment in patchy loss of skin pigmentation. 
Scientific Title of Study   An open label, randomized, comparative, study to evaluate efficacy, safety and remission period of Topical Tacrolimus 0.1 percent ointment and Topical Tofacitinib 2 percent ointment in patients with focal vitiligo. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IIS/2025/01 Version 1.0 dated 19-Feb-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishalakshi Viswanath 
Designation  Medical director 
Affiliation  DISHA Skin and Laser Institute 
Address  Department of Dermatology, DISHA Skin and Laser Institute, room no.101, Srushti Prime, Gokhale Rd, Naupada, Thane West

Thane
MAHARASHTRA
400602
India 
Phone  9324086679  
Fax    
Email  visha1967@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishalakshi Viswanath 
Designation  Medical director 
Affiliation  DISHA Skin and Laser Institute 
Address  Department of Dermatology, DISHA Skin and Laser Institute, room no.101, Srushti Prime, Gokhale Rd, Naupada, Thane West

Thane
MAHARASHTRA
400602
India 
Phone  9324086679  
Fax    
Email  visha1967@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishalakshi Viswanath 
Designation  Medical director 
Affiliation  DISHA Skin and Laser Institute 
Address  Department of Dermatology, DISHA Skin and Laser Institute, room no.101, Srushti Prime, Gokhale Rd, Naupada, Thane West

Thane
MAHARASHTRA
400602
India 
Phone  9324086679  
Fax    
Email  visha1967@gmail.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Limited. Glenmark House, B. D. Sawant Marg, Chakala,Andheri (E), Mumbai – 400099 
 
Primary Sponsor  
Name  Dr Vishalakshi Viswanath 
Address  DISHA Skin and Laser Institute, Department of Dermatology, room no. 101, Srushti Prime, Gokhale Rd, Naupada, Thane West, Maharashtra 400602 
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 Vishalakshi Viswanath  DISHA Skin and Laser Institute  Department of Dermatology, room no 101, Srushti Prime, Gokhale Rd, Naupada, Thane West, Maharashtra 400602
Thane
MAHARASHTRA 
9324086679

visha1967@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Suraksha-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 
Intervention  Topical Tacrolimus 0.1% ointment  Twice a day for 12 weeks 
Comparator Agent  Topical Tofacitinib 2% ointment  Twice a day for 12 weeks 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients eligible for enrolment in the study must meet all of the following criteria:
1. Male or female subjects aged between 02-65 years with focal vitiligo.
2. Patients with minimum of 2 lesions Excluding mucosal lesions with minimum patch size of 8 to 12 cm2 with involvement of less than 10% BSA, present on areas of face, trunk and upper limb.
3. No serious health conditions that may interfere with the study
4. The parent, guardian of child should give written Parental Consent form, Assent form, Informed Consent Form for participation in study. 
 
ExclusionCriteria 
Details  Patients meeting any of the following criteria must not be enrolled in the study:
1. History of skin disease or presence of skin condition that would interfere with the study assessments.
2. Any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
3. Known hypersensitivity to tacrolimus, tofacitinib or any of the excipients used in the formulation.
4. Subject who have taken any treatment for vitiligo (systemic, topical or phototherapy) for 14 days prior to being randomized. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Percentage of Patients with achievement of VASI-75 or complete re-pigmentation at the end of Week 12.
2. Percentage of patients who shows relapse after achieving VASI 75. (relapse of vitiligo is defined as appearance of new lesions or increase in extent of existing lesions)
3. Percentage of patients who show relapse within 16 weeks follow-up of achieving VASI 75. 
1. Upto 12 weeks
2. From 12th week to 28th week
3. From 12th week to 28th week 
 
Secondary Outcome  
Outcome  TimePoints 
1. Incidence of Treatment Emergent Adverse Events till end of the study.
2. Evaluation of cutaneous tolerability in terms of redness, erythema, dryness, scaling, and burning/irritation sensation till end of the study. 
1. Upto 28 weeks
2. Upto 28 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   05/04/2025 
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 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 is an open label, randomized, comparative, investigator initiated study to evaluate efficacy, safety and remission rate with Topical Tacrolimus 0.1% ointment vs Topical Tofacitinib 2% ointment in Indian patients with focal vitiligo.  
This study is planned in 70 Indian patients. Each patient will undergo 12 weeks of treatment period and further 16 weeks of follow up. Efficacy assessment will be done at all visits till week 12 and safety assessment will be done through out the study duration.
 
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