Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Conditions
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Alopecia Areata, Alopecia Totalis, Alopecia Universalis

Intervention / Treatment
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* Drug: Tofacitinib ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tofacitinib ointment<br>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. | Drug: Tofacitinib ointment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alopecia