Alopecia Areata (AA), Alopecia Totalis (AT), Alopecia Universalis (AU)
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 a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.
Interventions
DRUGTofacitinib Administration
5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Sponsors
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
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 |
|---|---|---|
| Mean Change in Severity of Alopecia Tool (SALT) Score | 3 months | SALT score range is from 0 (no hair loss) to 100 (100% hair loss) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Skindex 16 Scores | 3 months | Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib Administration 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Tofacitinib Administration |
|---|---|
| Age, Continuous | 37.9 years STANDARD_DEVIATION 15.12 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Mean Change in Severity of Alopecia Tool (SALT) Score
SALT score range is from 0 (no hair loss) to 100 (100% hair loss)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Administration | Mean Change in Severity of Alopecia Tool (SALT) Score | 22.8 percent change in SALT score | Standard Deviation 30.3 |
Secondary
Mean Change in Skindex 16 Scores
Skindex 16 is a quality of life questionaire with a range of 0-100 wherein 1 is not bothered by the condition and 100 is always bothered by the condition
Time frame: 3 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tofacitinib Administration | Mean Change in Skindex 16 Scores | -20.3 units on a scale |