Completed

Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

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What is being tested

Tofacitinib ointment

Drug
Who is being recruted

Alopecia+5

+ Alopecia Areata

+ Hair Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2016
See protocol details

Summary

Principal SponsorYale University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleTopical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
NCT02812342
Principal SponsorYale University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AlopeciaAlopecia AreataHair DiseasesHypotrichosisSkin DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesPathological Conditions, Anatomical

Criteria

4 inclusion criteria required to participate
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
9 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Yale-New Haven Hospital

New Haven, United StatesOpen Yale-New Haven Hospital in Google Maps
CompletedOne Study Center