Skip to main content
OpenTrials
Completed

NCT Number: NCT02197455

Tofacitnib for the Treatment of Alopecia Areata and Variants

The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University

New Haven, Connecticut, United States

About this study

This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >= 18 years old
  • Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
  • Hair loss present for at least 6 months
  • No treatment for alopecia areata in past 2 months
  • No evidence of hair regrowth
  • Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication

Exclusion criteria

  • Age <18 years old
  • Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
  • 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 with peptic ulcer disease
  • Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
  • Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
  • Women who are pregnant or nursing

Treatment and study plan

Tofacitinib Administration

Drug

5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

Primary outcomes

  1. Mean Change in Severity of Alopecia Tool (SALT) Score

    Time frame: 3 months

    SALT score range is from 0 (no hair loss) to 100 (100% hair loss)

Secondary outcomes

  1. Mean Change in Skindex 16 Scores

    Time frame: 3 months

    Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 22, 2014
Registry last updated
Apr 4, 2017

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.

Published trials that share one or more normalized conditions with this study.