Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

• ClinicalTrials.gov Identifier: NCT02812342
• Recruitment Status: Completed
• First Posted: June 24, 2016
• Results First Posted: October 10, 2018
• Last Update Posted: January 30, 2019
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alopecia Areata; Alopecia Totalis; Alopecia Universalis	Drug: Tofacitinib ointment	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
• Study Start Date: September 2016
• Actual Primary Completion Date: July 2018
• Actual Study Completion Date: December 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Percent Change in Severity of Alopecia Tool (SALT) Score [ Time Frame: 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 :

1. Treatment Response Assessed as the Number of Participants With Hair Regrowth [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Yale University

Investigators

• Principal Investigator: Brett King, MD, PhD; Yale University

  Study Documents (Full-Text)

Documents provided by Yale University:

Study Protocol and Statistical Analysis Plan  [PDF] March 11, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02812342
• Other Study ID Numbers: 1510016586
• First Posted: June 24, 2016
• Results First Posted: October 10, 2018
• Last Update Posted: January 30, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Yale University:

Alopecia

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Tofacitinib; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action