Tofacitinib for the Treatment of Alopecia Areata and Its Variants
This trial is active, not recruiting.
|Conditions||alopecia areata, alopecia totalis, alopecia universalis|
|Start date||December 2014|
|End date||December 2017|
|Trial size||40 participants|
|Trial identifier||NCT02312882, 31790ORO|
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.
|Intervention model||single group assignment|
Mean Change in Severity of Alopecia Tool (SALT) Score
time frame: 0 and 3 months
Male or female participants at least 18 years old.
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
|Description||This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months. Participants will be evaluated for 6 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.|
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