A clinical trial to study and compare the effect of two drugs, tofacitinib vs dexamethasone in patients with vitiligo

To compare the efficacy and safety of low dose tofacitinib versus oral corticosteroid (dexamethasone) mini pulse along with topical PUVAsol in stabilization and repigmentation of cutaneous lesions in rapidly progressive vitiligo. An open label active controlled randomized study. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091998

Enrollment

Registered

2025-07-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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: oral low dose tofacitinib: oral low dose tofacitinib 5 mg OD along with topical PUVAsol every alternate day for 3 months Control Intervention1: Oral corticosteroid (dexamethasone) mini

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis: Vitiligo patient with active disease i.e. VIDA 4+ 2. Patients having vitiligo for more than 6 months. 3. Body surface area (BSA) involvement is less than 5 % 4. Participants must be adult of age group 18-60 years old 5. Any sex 6. Presenting to the Dermatology OPD. 7. Participants providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients unwilling to give written informed consent to participate in the study. 2. Patients of vitiligo with other major dermatological ailments ( Immunobullous disease, SLE, Connective tissue diseases, Autoimmune diseases, Vasculitis). 3. Patients with underlying hepatic, renal diseases, coronary artery disease (CAD) 4. Patients with any major contraindications to the use of tofacitinib. 5. Pregnant, lactating female

Design outcomes

Primary

Measure	Time frame
To evaluate the number of patients achieving the arrest of progression of the disease i.e decrease of VIDA score by 1 point in low dose tofacitinib (Group A) and oral corticosteroid (dexamethasone) mini pulse (Group B. 2. To evaluate number of patients achieving more than 50 percent of repigmentation in each group.Timepoint: 16 weeks	—

Secondary

Measure	Time frame
1. To evaluate the percentage of patients maintaining arrest of the disease in each group at 24 weeks. 2. To compare the patients achieving arrest of progression and repigmentation between the groups A and B at 16 and 24 weeks. 3. To evaluate change in mean VASI and mean Physician global assessment scores from baseline to end of 16 weeks and end of 24 weeks within and between groups A and B. 4. To analyse patient global assessment using patient satisfaction score and Patient reported outcome measures (PROM) VitiQoL at 16 and 24 weeks within and between group A and group B.Timepoint: at 16 and 24 weeks	—

Measure

Time frame

1. To evaluate the percentage of patients maintaining arrest of the disease in each group at 24 weeks. 2. To compare the patients achieving arrest of progression and repigmentation between the groups A and B at 16 and 24 weeks. 3. To evaluate change in mean VASI and mean Physician global assessment scores from baseline to end of 16 weeks and end of 24 weeks within and between groups A and B. 4. To analyse patient global assessment using patient satisfaction score and Patient reported outcome measures (PROM) VitiQoL at 16 and 24 weeks within and between group A and group B.Timepoint: at 16 and 24 weeks

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Countries

India

Contacts

Public ContactDr Alka Yadav

All India Institute of Medical Science,AIIMS Rajkot

yashdeepsinghpathania@gmail.com

Outcome results

None listed

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