Health TrialsbyHealthPanel

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

ConditionsAlopecia AreataAlopecia Totalis (AT)Alopecia Universalis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHayat Abad Medical Complex, Peshawar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tofacitinib

    Drug

    Oral tofacitinib 10 mg twice daily for 12 weeks.

  • 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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Tofacitinib 10 mg Twice DailyExperimental treatment 1 intervention
Group B: Methotrexate 0.2-0.4 mg/kg WeeklyActive comparator 1 intervention

Trial outcomes

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.

Time frame
Week 12

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hayat Abad Medical Complex, Peshawar

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: