Tofacitinib vs Methotrexate for Severe Alopecia Areata (TOFA-MTX-AA)

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.

NCT Number	NCT07406204
Lead Sponsor	Hayat Abad Medical Complex, Peshawar
Conditions	Alopecia Areata, Alopecia Totalis (AT), Alopecia Universalis
Enrollment	78 participants
Start Date	2026-02-15
Primary Completion	2026-08-15 (estimated)
Study Completion	2026-08-15 (estimated)
Updated on ClinicalTrials.gov	2026-02-12