Phase 2
N=10
Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
Alopecia Areata · Alopecia Totalis · Alopecia Universalis
Bottom Line
View on ClinicalTrials.gov: NCT02812342 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Percent Change in Severity of Alopecia Tool (SALT) Score — 10 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tofacitinib ointment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Severity of Alopecia Tool (SALT) Score |
10 | — |
| SECONDARY Treatment Response Assessed as the Number of Participants With Hair Regrowth |
3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02812342). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.