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OpenTrials
Completed

NCT Number: NCT02812342

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tofacitinib ointment

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2016
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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