Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

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.

Study Overview

• Status: Completed
• Conditions: Alopecia Areata; Alopecia Totalis; Alopecia Universalis
• Intervention / Treatment: Drug: Tofacitinib ointment

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Brett King, MD, PhD, Yale University

Publications and helpful links

General Publications

• Bayart CB, DeNiro KL, Brichta L, Craiglow BG, Sidbury R. Topical Janus kinase inhibitors for the treatment of pediatric alopecia areata. J Am Acad Dermatol. 2017 Jul;77(1):167-170. doi: 10.1016/j.jaad.2017.03.024. No abstract available.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Alopecia
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: 1510016586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided