Alopecia Areata, Alopecia Totalis, Alopecia Universalis
Conditions
Keywords
Alopecia
Brief 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.
Detailed description
This will be an open label clinical trial. We plan to treat 10 adults with AA (with at least 2 patches of alopecia involving the scalp), AT or AU with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. Laboratory evaluation will be performed before and during treatment in order to monitor for adverse effects of the medication.
Interventions
DRUGTofacitinib ointment
Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.
Sponsors
Yale 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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Severity of Alopecia Tool (SALT) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Response Assessed as the Number of Participants With Hair Regrowth | 6 Months | Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib Ointment Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.
Tofacitinib ointment: Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Tofacitinib Ointment |
|---|---|
| Age, Continuous | 36.9 years STANDARD_DEVIATION 14.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| SALT score | 77.7 units on a scale STANDARD_DEVIATION 32.3 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 |
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). 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.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tofacitinib Ointment | Percent Change in Severity of Alopecia Tool (SALT) Score | 10 percent change |
Secondary
Treatment Response Assessed as the Number of Participants With Hair Regrowth
Clinical photographs will be used to demonstrate presence or absence of hair regrowth. Presented is a count of people that did respond to treatment.
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tofacitinib Ointment | Treatment Response Assessed as the Number of Participants With Hair Regrowth | 3 Participants |