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

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.

Timeline

Start

2026-02-15

Primary completion

2026-08-15

Completion

2026-08-15

Publications

• Results Abe DT, Tashima LM, Basilio FMA, Mulinari-Brenner F. Clinical Experience with Oral Tofacitinib in a Patient with Alopecia Areata Universalis and Rheumatoid Arthritis. Int J Trichology. 2020 Jul-Aug;12(4):188-190. doi: 10.4103/ijt.ijt_107_20. Epub 2020 Sep 19.
• Results Asma JK, Huma AS, Urooj M. A study on the role of tofacitinib among patients treated with alopecia areata. Pak J Med Health Sc. 2022;16(12):801-3.
• Results Iorizzo M, Tosti A. Emerging drugs for alopecia areata: JAK inhibitors. Expert Opin Emerg Drugs. 2018 Mar;23(1):77-81. doi: 10.1080/14728214.2018.1444750. Epub 2018 Feb 26.
• Results Cervantes J, Jimenez JJ, DelCanto GM, Tosti A. Treatment of Alopecia Areata with Simvastatin/Ezetimibe. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S25-S31. doi: 10.1016/j.jisp.2017.10.013.
• Results Strazzulla LC, Avila L, Lo Sicco K, Shapiro J. An Overview of the Biology of Platelet-Rich Plasma and Microneedling as Potential Treatments for Alopecia Areata. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S21-S24. doi: 10.1016/j.jisp.2017.10.002.
• Results Lee S, Kim BJ, Lee YB, Lee WS. Hair Regrowth Outcomes of Contact Immunotherapy for Patients With Alopecia Areata: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018 Oct 1;154(10):1145-1151. doi: 10.1001/jamadermatol.2018.2312.
• Results Ro BI. Alopecia areata in Korea (1982-1994). J Dermatol. 1995 Nov;22(11):858-64. doi: 10.1111/j.1346-8138.1995.tb03936.x.
• Results Melo DF, Dutra TBS, Baggieri VMAC, Tortelly VD. Intralesional betamethasone as a therapeutic option for alopecia areata. An Bras Dermatol. 2018 Mar;93(2):311-312. doi: 10.1590/abd1806-4841.20187423. No abstract available.
• Results Chu TW, AlJasser M, Alharbi A, Abahussein O, McElwee K, Shapiro J. Benefit of different concentrations of intralesional triamcinolone acetonide in alopecia areata: An intrasubject pilot study. J Am Acad Dermatol. 2015 Aug;73(2):338-40. doi: 10.1016/j.jaad.2015.04.049. No abstract available.
• Results Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladden M. British Association of Dermatologists' guidelines for the management of alopecia areata 2012. Br J Dermatol. 2012 May;166(5):916-26. doi: 10.1111/j.1365-2133.2012.10955.x. No abstract available.
• Results Rajabi F, Drake LA, Senna MM, Rezaei N. Alopecia areata: a review of disease pathogenesis. Br J Dermatol. 2018 Nov;179(5):1033-1048. doi: 10.1111/bjd.16808. Epub 2018 Sep 9.
• Results Mirzoyev SA, Schrum AG, Davis MDP, Torgerson RR. Lifetime incidence risk of alopecia areata estimated at 2.1% by Rochester Epidemiology Project, 1990-2009. J Invest Dermatol. 2014 Apr;134(4):1141-1142. doi: 10.1038/jid.2013.464. Epub 2013 Nov 11. No abstract available.
• Results Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ 3rd. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995 Jul;70(7):628-33. doi: 10.4065/70.7.628.
• Results Pratt CH, King LE Jr, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017 Mar 16;3:17011. doi: 10.1038/nrdp.2017.11.
• Results Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med. 2012 Apr 19;366(16):1515-25. doi: 10.1056/NEJMra1103442. No abstract available.

Drugs

Indications