Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Yale University10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alopecia Areata Alopecia Totalis Alopecia Universalis

Interventions

Tofacitinib ointmentDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Yale-New Haven Hospital

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Percent Change in Severity of Alopecia Tool (SALT) Score

SALT score range is from 0 (no hair loss) to 100 (100% hair loss). A positive percent change from baseline corresponds to a reduction in SALT score, and in this study study will be measured between baseline and 6 months.

Time frame: 6 Months

Secondary Outcomes

Treatment Response Assessed as the Number of Participants With Hair Regrowth

Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment.

Time frame: 6 Months

Data from ClinicalTrials.gov

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