Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Yale University

Status and phase: Completed; Phase 2

Conditions: Alopecia Totalis; Alopecia Universalis; Alopecia Areata

Treatments: Drug: Tofacitinib ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT02812342

1510016586

Details and patient eligibility

About

The purpose of the study is to investigate the use of topical tofacitinib to promote hair regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.

Full description

This will be an open label clinical trial. We plan to treat 10 adults with AA (with at least 2 patches of alopecia involving the scalp), AT or AU with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. Laboratory evaluation will be performed before and during treatment in order to monitor for adverse effects of the medication.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of AA with at least 2 patches of alopecia involving the scalp, AT or AU
• Stable hair loss present for 6 months or longer
• No treatment for alopecia areata in the past 1 month
• No evidence of spontaneous hair regrowth

Exclusion criteria

• Patients have received treatment known to affect alopecia areata within 1 month of enrolling in the study
• Patients whose current episode of AT or AU is more than 5 years
• 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 taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNF-α inhibitors
• Women who are pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Tofacitinib ointment

Experimental group

Description:

Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.

Treatment:

Drug: Tofacitinib ointment