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Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Primary Purpose

Alopecia Areata, Alopecia Totalis, Alopecia Universalis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tofacitinib ointment
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale-New Haven Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tofacitinib ointment

Arm Description

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.

Outcomes

Primary Outcome Measures

Percent Change in Severity of Alopecia Tool (SALT) Score
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

Treatment Response Assessed as the Number of Participants With Hair Regrowth
Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment.

Full Information

First Posted
June 21, 2016
Last Updated
January 10, 2019
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02812342
Brief Title
Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Official Title
Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata, Alopecia Totalis, Alopecia Universalis
Keywords
Alopecia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tofacitinib ointment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tofacitinib ointment
Intervention Description
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 Measure Information:
Title
Percent Change in Severity of Alopecia Tool (SALT) Score
Description
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.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Treatment Response Assessed as the Number of Participants With Hair Regrowth
Description
Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett King, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28619556
Citation
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. No abstract available.
Results Reference
derived

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Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

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