Comparison of Tofacitinib versus betamethasone oral mini pulse in progressive vitiligo

Safety and efficacy of oral tofacitinib versus betamethasone oral mini-pulse therapy in the treatment of progressive non-segmental vitiligo: a pilot randomized clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062634

Enrollment

Registered

2024-02-14

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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: Tofacitinib: Oral tofacitinib 5mg twice daily for six months Control Intervention1: Betamethasone oral mini-pulse: Oral betamethasone 5mg on 2 consecutive day per week for six months

Eligibility

Inclusion criteria

Inclusion criteria: patients with rapidly progressive non segmental vitiligo with more than or equal to 5 new lesions in a month or more than or equal to 15 new lesions in 3 months

Exclusion criteria

Exclusion criteria: 1. Patients with segmental or stable or slowly progressive vitiligo 2. Pregnant or lactating females 3. Patients with known contraindictions to oral steroids or tofacitinib 4. Patients on topical treatment for last 2 weeks or systemic treatment for 4 weeks 5. Patients with latent tuberculosis infection not willing to take isoniazid preventive treatment

Design outcomes

Primary

Measure	Time frame
Proportion of patients with disease arrest (no new lesions and no progression of pre-existing patches) at every visit as confirmed on sequential photographsTimepoint: at 4, 8, 12, 16, 20 and 24 weeks (at every visit)	—

Secondary

Measure	Time frame
Comparison of side effects profile in both groupsTimepoint: at every follow up visit;Mean number of new vitiligo lesions during the study period (intra- and inter group comparison)Timepoint: at every visit;Mean VDAS and VDIS scores during the study period (intra- and inter group comparison)Timepoint: at 3rd and 6th month visit;Mean VES (intra- and inter group comparison)Timepoint: at baseline, 3rd and 6th month visit;Mean VIS-22 scores (intra- and inter group comparison)Timepoint: at baseline, 3rd and 6th month visit;Mean VSAS score during the study period (intra- and inter group comparison)Timepoint: at every visit;Proportion of patients in different VIDA score categories (inter-group comparison)Timepoint: at every visit;Proportion of patients with a change of VIS-22 score more than 5 points (inter-group comparison)Timepoint: at 6th month visit;Proportion of patients with different GQ responses (inter-group comparison)Timepoint: at every follow up visit	—

Measure

Time frame

Comparison of side effects profile in both groupsTimepoint: at every follow up visit;Mean number of new vitiligo lesions during the study period (intra- and inter group comparison)Timepoint: at every visit;Mean VDAS and VDIS scores during the study period (intra- and inter group comparison)Timepoint: at 3rd and 6th month visit;Mean VES (intra- and inter group comparison)Timepoint: at baseline, 3rd and 6th month visit;Mean VIS-22 scores (intra- and inter group comparison)Timepoint: at baseline, 3rd and 6th month visit;Mean VSAS score during the study period (intra- and inter group comparison)Timepoint: at every visit;Proportion of patients in different VIDA score categories (inter-group comparison)Timepoint: at every visit;Proportion of patients with a change of VIS-22 score more than 5 points (inter-group comparison)Timepoint: at 6th month visit;Proportion of patients with different GQ responses (inter-group comparison)Timepoint: at every follow up visit

—

Countries

India

Contacts

Public ContactVishal Gupta

AIIMS, New Delhi

doctor.vishalgupta@gmail.com9871213543

Outcome results

None listed

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