Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Not Applicable
Completed
- Conditions
- Alopecia AreataAlopecia TotalisAlopecia 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
Group Intervention Description Tofacitinib Tofacitinib Participants will receive tofacitinib for 3 months.
- Primary Outcome Measures
Name Time Method Percent Change in Severity of Alopecia Tool (SALT) Score 0 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
Name Time Method
Trial Locations
- Locations (1)
Stanford University
🇺🇸Stanford, California, United States