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

NCT07406204 | Not Yet Recruiting Phase 4

• 1 other identifier: HMC-DERM-TOFA-MTX-AA
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alopecia Totalis (AT); Alopecia Areata; Alopecia Universalis

Keywords

Tofacitinib; Methotrexate; Janus Kinase Inhibitor; Severe Alopecia Areata; Autoimmune Hair Loss

Outcome Measures

Primary Outcomes (1)

• Change in Severity of Alopecia Tool (SALT) Score

  SALT score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. The primary outcome is the change in SALT score from baseline to week 12, compared between the tofacitinib and methotrexate groups.

  Week 12

Study Arms (2)

Tofacitinib 10 mg Twice Daily

EXPERIMENTAL

Participants will receive oral tofacitinib 10 mg twice daily for 12 weeks. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as \>50% improvement in SALT score from baseline.

Drug: Tofacitinib

Methotrexate 0.2-0.4 mg/kg Weekly

ACTIVE COMPARATOR

Participants will receive oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks with routine follow-up and laboratory monitoring for adverse effects as per institutional protocol. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as \>50% improvement in SALT score from baseline.

Drug: Methotrexate

Interventions

Tofacitinib DRUG

Oral tofacitinib 10 mg twice daily for 12 weeks.

Tofacitinib 10 mg Twice Daily

Methotrexate DRUG

Oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks, with routine monitoring for adverse effects as per institutional protocol.

Methotrexate 0.2-0.4 mg/kg Weekly

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Related Publications (15)

• 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;12(4):188-90.

  RESULT

• 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.

  RESULT

• Iorizzo M, Tosti A. Emerging drugs for alopecia areata: JAK inhibitors. Expert Opin Emerg Drugs. 2018;23(1):77-81.

  RESULT

• Cervantes J, Jimenez JJ, DelCanto GM, Tosti A. Treatment of alopecia areata with simvastatin/ezetimibe. J Investig Dermatol Symp Proc. 2018;19(1):S25-S31.

  RESULT

• 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;19(1):S21-S24.

  RESULT

• 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;154(10):1145-51.

  RESULT

• Ro BI. Alopecia areata in Korea (1982-1994). J Dermatol. 1995;22(11):858-64.

  RESULT

• Melo DF, Dutra TBS, Baggieri VMAC, Tortelly VD. Intralesional betamethasone as a therapeutic option for alopecia areata. an Bras Dermatol. 2018;93(2):311-12

  RESULT

• Chu TW, AlJasser M, Alharbi A, Abahussein O, McElwee K, Shapiro J, et al. Benefit of different concentrations of intralesional triamcinolone acetonide in alopecia areata: an intrasubject pilot study. J Am Acad Dermatol. 2015;73(2):338-40.

  RESULT

• 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;166(5):916-26.

  RESULT

• Rajabi F, Drake LA, Senna MM, Rezaei N. Alopecia areata: a review of disease pathogenesis. Br J Dermatol. 2018;179(5):1033-48.

  RESULT

• 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;134(4):1141-2.

  RESULT

• Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton LJ. Incidence of alopecia areata in Olmsted County, Minnesota, 1975 through 1989. Mayo Clin Proc. 1995;70(7):628-33

  RESULT

• Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3:17011.

  RESULT

• Gilhar A, Etzioni A, Paus R. Alopecia areata. N Engl J Med. 2012;366(16):1515-5.

  RESULT

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis

Interventions

tofacitinib; Methotrexate

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Hira Rehman, FCPS

CONTACT

03359849292; khira420.hr@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Due to different dosing schedules and monitoring requirements for the two interventions, blinding of participants, treating clinicians, investigators, and outcome assessors will not be feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGR

Model Details: Participants will be randomized in a 1:1 ratio to two parallel treatment arms (tofacitinib vs methotrexate) and followed for 12 weeks. Efficacy will be assessed by change in SALT score from baseline to week 12.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share