Hair loss drug showdown: tofacitinib vs methotrexate in new trial
NCT ID NCT07406204
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two oral medications—tofacitinib and methotrexate—for treating severe alopecia areata, an autoimmune condition causing hair loss. 78 adults aged 18-60 with severe scalp or total body hair loss will take one of the drugs for 12 weeks. The main goal is to see which medicine leads to more hair regrowth, measured by a standard hair loss score.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tofacitinib and methotrexate
- What this could lead to
- If successful, this could show that tofacitinib is a more effective option than methotrexate for regrowing hair in severe alopecia areata.
- What could go wrong
- This is a small, early-stage trial with only 78 participants and a short 12-week treatment period. Results may not apply to everyone, and both drugs have side effects like infection risk.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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- Can a daily pill bring back hair in severe alopecia?