NCT02812342

Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Completed Phase 2 Results posted Last updated 10 January 2019

What this trial tests

Phase 2 trial testing Tofacitinib ointment in Alopecia Areata in 10 participants. Completed in 1 December 2018.

Timeline

1 September 2016

Primary endpoint
1 July 2018

1 December 2018

Quick facts

Lead sponsor	Yale University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 September 2016
Primary completion	1 July 2018
Estimated completion	1 December 2018
Sites	1 location across United States

Drugs / interventions tested

• Tofacitinib ointment

Conditions studied

• Alopecia Areata — all drugs for Alopecia Areata →
• Alopecia Totalis — all drugs for Alopecia Totalis →
• Alopecia Universalis — all drugs for Alopecia Universalis →

Sponsor

Yale University

Who can join

18 and older, any sex, with Alopecia Areata or Alopecia Totalis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. JAK inhibitors in dermatology: The promise of a new drug class.
   Damsky W, King BA. · · 2017 · cited 353× · PMID 28139263 · DOI 10.1016/j.jaad.2016.12.005
2. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases.
   Schwartz DM, Kanno Y, Villarino A, Ward M, et al · · 2017 · cited 308× · PMID 29282366 · DOI 10.1038/nrd.2017.267
3. JAK-inhibitors. New players in the field of immune-mediated diseases, beyond rheumatoid arthritis.
   Fragoulis GE, McInnes IB, Siebert S. · · 2019 · cited 223× · PMID 30806709 · DOI 10.1093/rheumatology/key276
4. Emerging Topical and Systemic JAK Inhibitors in Dermatology.
   Solimani F, Meier K, Ghoreschi K. · · 2019 · cited 199× · PMID 31849996 · DOI 10.3389/fimmu.2019.02847
5. Targeting the Janus Kinase Family in Autoimmune Skin Diseases.
   Howell MD, Kuo FI, Smith PA. · · 2019 · cited 180× · PMID 31649667 · DOI 10.3389/fimmu.2019.02342
6. An overview of JAK/STAT pathways and JAK inhibition in alopecia areata.
   Lensing M, Jabbari A. · · 2022 · cited 100× · PMID 36110853 · DOI 10.3389/fimmu.2022.955035
7. Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
   Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850
8. JAK Inhibitors for Treatment of Alopecia Areata.
   Wang EHC, Sallee BN, Tejeda CI, Christiano AM. · · 2018 · cited 58× · PMID 30057345 · DOI 10.1016/j.jid.2018.05.027