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Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Yale University

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.

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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


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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812342


Locations
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United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Brett King, MD, PhD Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02812342    
Other Study ID Numbers: 1510016586
First Posted: June 24, 2016    Key Record Dates
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:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action