Alopecia Areata, Alopecia Totalis, Alopecia Universalis
Conditions
Brief 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.
Detailed description
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.
Interventions
DRUGTofacitinib
Tofacitinib 5 mg tablet taken by mouth twice a day.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Fluent in spoken and written English
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Severity of Alopecia Tool (SALT) Score | 0 and 3 months | SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months. | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 37 years |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Percent Change in Severity of Alopecia Tool (SALT) Score
SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score.
Time frame: 0 and 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Arm | Percent Change in Severity of Alopecia Tool (SALT) Score | 30.7 Percent change |
p-value: <0.0001Wilcoxon (Mann-Whitney)