NCT02812342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 10, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

1.8 years

First QC Date

June 21, 2016

Results QC Date

September 12, 2018

Last Update Submit

January 10, 2019

Conditions

Alopecia AreataAlopecia TotalisAlopecia Universalis

Keywords

Alopecia

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 Months

Secondary Outcomes (1)

  • Treatment Response Assessed as the Number of Participants With Hair Regrowth

    6 Months

Study Arms (1)

Tofacitinib ointment

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.

Drug: Tofacitinib ointment

Interventions

Tofacitinib ointmentDRUG

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.

Tofacitinib ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • 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.

    PMID: 28619556DERIVED

MeSH Terms

Conditions

Alopecia AreataAlopecia universalisAlopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Brett King, MD, PhD, BA, Associate Professor of Dermatology
Organization
Yale Dermatology - Middlebury
brett.king@yale.edu
(203) 737-4825

Study Officials

  • Brett King, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 24, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2018

Study Completion

December 1, 2018

Last Updated

January 30, 2019

Results First Posted

October 10, 2018

Record last verified: 2019-01

Locations

US(1)