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Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Not Applicable
Completed
Conditions
Alopecia Areata
Alopecia Totalis
Alopecia Universalis
Interventions
Registration Number
NCT02312882
Lead Sponsor
Stanford University
Brief Summary

The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

Detailed Description

This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Age >= 18 years old
  • Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
  • Hair loss present for at least 6 months
  • No treatment for alopecia areata in past 2 months
  • No evidence of hair regrowth
  • Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication
  • Fluent in spoken and written English
Exclusion Criteria
  • Age <18 years old
  • Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
  • Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
  • Patients known to be HIV or hepatitis B or C positive
  • Patients with positive tuberculin skin test or positive QuantiFERON TB test
  • Patients with leukopenia or anemia
  • Patients with renal or hepatic impairment
  • Patients with peptic ulcer disease
  • Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
  • Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
  • Women who are pregnant or nursing

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
TofacitinibTofacitinibParticipants will receive tofacitinib for 3 months.
Primary Outcome Measures
NameTimeMethod
Percent Change in Severity of Alopecia Tool (SALT) Score0 and 3 months

SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Stanford University

🇺🇸

Stanford, California, United States

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