Phase 2
N=30
Tofacitnib for the Treatment of Alopecia Areata and Variants
Alopecia Areata (AA) · Alopecia Totalis (AT) · Alopecia Universalis (AU)
Bottom Line
View on ClinicalTrials.gov: NCT02197455 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Mean Change in Severity of Alopecia Tool (SALT) Score — 22.8 percent change in SALT score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tofacitinib Administration (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Severity of Alopecia Tool (SALT) Score |
22.8 | — |
| SECONDARY Mean Change in Skindex 16 Scores |
-20.3 | — |
Summary
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.
Eligibility Criteria
Inclusion Criteria
- Age >= 18 years old
- Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
- Hair loss present for at least 6 months
- No treatment for alopecia areata in past 2 months
- No evidence of hair regrowth
- Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication
Exclusion Criteria
- Age <18 years old
- Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
- 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 with peptic ulcer disease
- Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
- Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
- Women who are pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT02197455). 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.