FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/12/060436 [Registered on: 01/12/2023] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study on efficacy, safety and tolerability of topical tofacitinib vs topical tofacitinib combined with puvasol in the management of vitiligo 
Scientific Title of Study   A prospective, comparative, randomised study on efficacy, safety and tolerability of topical tofacitinib vs topical tofacitinib with puvasol in the management of 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  Rohini Amar Rathod 
Designation  Junior Resident 
Affiliation  Shri Bhausaheb Hire Government Medical College and Hospital, Dhule 
Address  OPD No.18, Department of Dermatology, Venereology and Leprosy, Shri Bhausaheb Hire Government Medical College and Hospital, Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  8983758338  
Fax    
Email  rarathod.02@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chetan Rajput 
Designation  Professor and Head Of Department 
Affiliation  Shri Bhausaheb Hire Government Medical College and Hospital, Dhule 
Address  OPD No 18, Department of Dermatology, Venereology and Leprosy, Shri Bhausaheb Hire Government Medical College and Hospital, Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  8983758338  
Fax    
Email  drchetanrajput@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Rohini Amar Rathod 
Designation  Junior Resident 
Affiliation  Shri Bhausaheb Hire Government Medical College and Hospital, Dhule 
Address  OPD No 18, Department of Dermatology, Venereology and Leprosy, Shri Bhausaheb Hire Government Medical College and Hospital, Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  8983758338  
Fax    
Email  rarathod.02@gmail.com  
 
Source of Monetary or Material Support  
Shri Bhausaheb Hire Government Medical College and Hospital, Dhule 
 
Primary Sponsor  
Name  Dr Rohini Rathod 
Address  OPD No 18, Department of Dermatology,Venereology and Leprosy,Shri Bhausaheb Hire Government Medical College and Hospital, Dhule 
Type of Sponsor  Other [Self Funded] 
 
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 Rohini Rathod  Shri Bhausaheb Hire Government Medical College and Hospital Dhule  OPD No 18, Department of Dermatology, Venereology and Leprosy, Shri Bhausaheb Hire Government Medical College and Hospital, Dhule
Dhule
MAHARASHTRA 		 8983758338

rarathod.02@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SBHGMC, DHULE  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  2% Topical tofacitinib cream  2% topical tofacitinib cream applied twice daily for 4 months  
Comparator Agent  2% Topical tofacitinib cream with oral puvasol  2% topical tofacitinib cream applied twice daily given along with puvasol- Trioxsalen 20-40mg orally 2 hours before sun exposure three times a week with 48 hours spacing given over a period of 4 months 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients who are clinically diagnosed cases of vitiligo
2)Both sexes – males and females
3)Age – above 12 years to 60 years
4)Body surface area involving the depigmented patches of less than 10%
5)Depigmented patches in exposed areas of the body
 
 
ExclusionCriteria 
Details  1)Patients having vitiligo patches in more than 10% BSA and having patches over flexure areas and genitals
2)Patients with active or latent TB
3)Patients with anaemia (Hb < 9g/dl) ,liver diseases, kidney disease, GI disease (diverticulitis, perforation ,ulcers ) , respiratory disease (ILD , COPD, pulmonary edema)
4)Patients with malignancies or lymphoproliferative disorders
5)Patients on potent immunosuppresants, biological DMARDS , H/O organ transplant
6)Patients with deranged lipid profile
7)H/O recent live vaccination
8)Age less than 12 years, pregnancy and lactation
9)Family history of melanoma/non melanoma skin cancers
10)People suffering from photosensitivity disorders
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the clinical efficacy of topical tofacitinib vs topical tofacitinib with puvasol in vitiligo patients with respect to repigmentation of skin  4 months 
 
Secondary Outcome  
Outcome  TimePoints 
To know the safety and tolerability of topical tofacitinib vs topical tofacitinib with puvasol in treatment of vitiligo.

 		 4 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) 22/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response (Others) - 

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 10-09-2023 and end date provided 10-09-2026?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Vitiligo is a chronic pigmentary skin disorder presenting with depigmented patches. The course of the disease is unpredictable and there are various treatment options available. This is a prospective, comparative, randomised clinical study to assess the safety, efficacy and tolerability of topical tofacitinib vs topical tofacitinib with puvasol in the treatment of vitiligo. Each group will have 33 patients each. The study will be conducted at a tertiary hospital. One group will be treated with 2% topical tofacitinib cream applied twice daily for a period of 4 months. The other group will be treated with 2% topical tofacitinib cream applied twice daily along with oral trioxsalen 20-40 mg give thrice a week 2 hours before sun exposure with 48 hours spacing for a period of 4 months. Thus the study aims to find the best possible results in the management of vitiligo. 
Close