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Study to check the efficacy and safety of the oral Tofacitinib against methylprednisolone oral minipulse therapy in vitiligo patients.

A , Single centric , assessor blind , open label randomized study to compare the efficacy and safety of the Tofacitinib versus methylprednisolone oral minipulse therapy in vitiligo patients. - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062419
Enrollment
60
Registered
2024-02-08
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: Oral Tofacitinib: Patients will be randomized into two groups
one group will receive Oral Tofacitinib in the dose of 5mg twice daily for 120 days and the other group will receive Oral methylprednisolone minipulse steroid treatment in standard doses of 0.5mg/Kg b
one group will receive Oral methylprednisolone minipulse steroid treatment in standard doses of 0.5mg/Kg body weight (maximum of 32mg on two consecutive days every week) for 120 days and the other gr

Sponsors

Dr Imran Majid
Lead Sponsor
Dr Sehar Imran
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a confirmed diagnosis of vitiligo, Washout period for Systemic medication for vitiligo for atleast 1 month before enrolment, Written informed consent signed by the patient or legally acceptable representative(s) in line with applicable regulation of country, Planned treatment in line with the Summary of Product Characteristics

Exclusion criteria

Exclusion criteria: any contraindication to any of the oral medications, women of childbearing age, pregnancy, lactation, any family history of diabetes in parents/siblings, Confirmed case of Latent Tuberculosis on investigation, unwillingness to conform to study protocol

Design outcomes

Primary

MeasureTime frame
The study is being planned to conduct a comparative assessment to explore the safety & efficacy of Oral Tofacitinib versus methylprednisolone oral minpulse therapy in vitiligo patients to develop/upgrade the literatureTimepoint: 1 year

Secondary

MeasureTime frame
To obtain safety information in terms of adverse events on the use Oral Tofacitinib versus methylprednisolone oral minpulse therapy in vitiligo patients.Timepoint: 1 year

Countries

India

Contacts

Public ContactDr Imran Majid

Cutis Institute of Dermatology

drimranmajid@gmail.com9906627070

Outcome results

None listed

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