Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Phase 2

Completed

• Conditions: Alopecia Areata; Alopecia Totalis; Alopecia Universalis
• Interventions: Drug: Tofacitinib ointment

• Registration Number: NCT02812342
• Lead Sponsor: Yale University

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-24
• Study Start: 2016-09
• Primary Completion: 2018-07
• Results First Submitted: 2018-09-12
• Results First Submitted QC: 2018-09-12
• Results First Posted: 2018-10-10
• Study Completion: 2018-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tofacitinib ointment	Tofacitinib ointment	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.

Primary Outcome Measures

Name	Time	Method
Percent Change in Severity of Alopecia Tool (SALT) Score	6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Treatment Response Assessed as the Number of Participants With Hair Regrowth	6 Months	Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment.

Trial Locations

Locations (1)

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States