Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA) (NCT07406204) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)
78 participantsStarted 2026-02-15
Plain-language summary
This study will compare two oral medicines-tofacitinib and methotrexate-for treating severe alopecia areata, including alopecia totalis (loss of all scalp hair) and alopecia universalis (loss of scalp and body hair). Alopecia areata is an autoimmune condition that can cause significant hair loss and emotional distress.
Adults aged 18 to 60 years with severe disease will be enrolled at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar, after ethical approval and written informed consent. Participants will be randomly assigned to receive either tofacitinib 10 mg twice daily or methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks.
The main outcome will be improvement in hair loss measured by the Severity of Alopecia Tool (SALT) score. Treatment will be considered effective if there is more than 50% improvement in SALT score from baseline at the end of 12 weeks. Safety will be monitored during follow-up visits. The findings may help guide treatment decisions for severe alopecia areata in our local population.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Adults aged 18-60 years.
Clinical diagnosis of severe alopecia areata, alopecia totalis, or alopecia universalis (as per protocol/operational definition), confirmed by a consultant dermatologist.
Either sex.
Able and willing to provide written informed consent.
Exclusion Criteria:
Currently receiving or recently used any systemic treatment intended for hair regrowth for alopecia areata (e.g., systemic corticosteroids, immunosuppressants, JAK inhibitors).
Pregnant women.
History or clinical evidence of renal, hepatic, or pulmonary disease.
Any condition that, in the investigator's judgment, makes participation unsafe or interferes with adherence to the study protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.