A clinical study to evaluate the effect and safety of Topical Tacrolimus and Topical Tofacitinib ointments for treatment in patchy loss of skin pigmentation.

Phase 4

Not yet recruiting

• Conditions: Vitiligo,

• Registration Number: CTRI/2025/03/083363
• Lead Sponsor: Dr Vishalakshi Viswanath

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-24
• Study Start: 2025-05-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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.
• 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.
• 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.

Exclusion Criteria

• 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.
• 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.
• Known hypersensitivity to tacrolimus, tofacitinib or any of the excipients used in the formulation.
• Subject who have taken any treatment for vitiligo (systemic, topical or phototherapy) for 14 days prior to being randomized.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percentage of Patients with achievement of VASI-75 or complete re-pigmentation at the end of Week 12.	1. Upto 12 weeks | 2. From 12th week to 28th week | 3. From 12th week to 28th week
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)	1. Upto 12 weeks | 2. From 12th week to 28th week | 3. From 12th week to 28th week
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

DISHA Skin and Laser Institute; 🇮🇳 Thane, MAHARASHTRA, India

DISHA Skin and Laser Institute

🇮🇳Thane, MAHARASHTRA, India

Dr Vishalakshi Viswanath

Principal investigator

9324086679

visha1967@gmail.com