Tofacitnib for the Treatment of Alopecia Areata and Variants



Status:Completed
Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 90
Updated:8/10/2016
Start Date:July 2014
End Date:July 2015

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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.

This study is an open-label pilot study. Participants will be treated with oral tofacitinib
for a maximum of 5 months. Participants will be evaluated at 3 months after completion of
therapy to evaluate for durability of response, late response and/or late adverse effects.

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

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
We found this trial at
1
site
New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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