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

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. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/083363

Enrollment

Registered

2025-03-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L80- Vitiligo

Interventions

Intervention1: Topical Tacrolimus 0.1% ointment: Twice a day for 12 weeks Control Intervention1: Topical Tofacitinib 2% ointment: Twice a day for 12 weeks

Eligibility

Inclusion criteria

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. 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.

Exclusion criteria

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. 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 1. Upto 12 weeks 2. From 12th week to 28th week 3. From 12th week to 28th week	—

Measure

Time frame

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.Timepoint: 1. Upto 12 weeks 2. From 12th week to 28th week 3. From 12th week to 28th week

—

Secondary

Measure	Time frame
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.Timepoint: 1. Upto 28 weeks 2. Upto 28 weeks	—

Countries

India

Contacts

Public ContactDr Vishalakshi Viswanath

DISHA Skin and Laser Institute

visha1967@gmail.com9324086679

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026