Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Alopecia Areata Clinical Trial

Official title:

Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02812342
• Other study ID #: 1510016586
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: December 2018

Study information

• Verified date: January 2019
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-a inhibitors

• Women who are pregnant or nursing

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia Totalis
• Alopecia Universalis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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