Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
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ClinicalTrials.gov Identifier: NCT02812342 |
Recruitment Status :
Completed
First Posted : June 24, 2016
Results First Posted : October 10, 2018
Last Update Posted : January 30, 2019
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Condition or disease | Intervention/treatment | Phase |
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Alopecia Areata Alopecia Totalis Alopecia Universalis | Drug: Tofacitinib ointment | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants |
Study Start Date : | September 2016 |
Actual Primary Completion Date : | July 2018 |
Actual Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: 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. |
- Percent Change in Severity of Alopecia Tool (SALT) Score [ Time Frame: 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.
- Treatment Response Assessed as the Number of Participants With Hair Regrowth [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812342
United States, Connecticut | |
Yale-New Haven Hospital | |
New Haven, Connecticut, United States, 06510 |
Principal Investigator: | Brett King, MD, PhD | Yale University |
Documents provided by Yale University:
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT02812342 |
Other Study ID Numbers: |
1510016586 |
First Posted: | June 24, 2016 Key Record Dates |
Results First Posted: | October 10, 2018 |
Last Update Posted: | January 30, 2019 |
Last Verified: | January 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Alopecia |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases |
Pathological Conditions, Anatomical Tofacitinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |