Trial Outcomes & Findings for Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants (NCT NCT02812342)

Last Updated: 2019-01-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

6 Months

Results posted on

2019-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Tofacitinib Ointment Patients with alopecia areata (AA) (with at least 2 patches of alopecia involving the scalp), alopecia totalis (AT) or alopecia universalis (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 between baseline and the end of study. 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 between baseline and end of study.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib Ointment n=10 Participants 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.
Age, Continuous	36.9 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
SALT score	77.7 units on a scale STANDARD_DEVIATION 32.3 • n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Tofacitinib Ointment n=10 Participants 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.
Percent Change in Severity of Alopecia Tool (SALT) Score	10 percent change Interval 0.0 to 61.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tofacitinib Ointment n=10 Participants 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.
Treatment Response Assessed as the Number of Participants With Hair Regrowth	3 Participants

Adverse Events

Tofacitinib Ointment

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tofacitinib Ointment n=10 participants at risk 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.
Infections and infestations Upper Respiratory Infection	40.0% 4/10 • 12 months
Infections and infestations Sinus Infection	10.0% 1/10 • 12 months
General disorders Headache	20.0% 2/10 • 12 months
Skin and subcutaneous tissue disorders Folliculitis	10.0% 1/10 • 12 months
Skin and subcutaneous tissue disorders Scalp Skin Irritation	40.0% 4/10 • 12 months

Additional Information

Brett King, MD, PhD, BA, Associate Professor of Dermatology

Yale Dermatology - Middlebury

Phone: (203) 737-4825

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place