Trial Outcomes & Findings for Tofacitinib for the Treatment of Alopecia Areata and Its Variants (NCT NCT02312882)

Last Updated: 2017-11-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

0 and 3 months

Results posted on

2017-11-06

Participant milestones
Measure	Tofacitinib Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
Overall Study STARTED	40
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	4

Withdrawal data not reported

Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Baseline characteristics by cohort
Measure	Treatment Arm n=36 Participants Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
Age, Continuous	37 years n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

Timeframe: 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.

Outcome measures
Measure	Treatment Arm n=36 Participants Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
Percent Change in Severity of Alopecia Tool (SALT) Score	30.7 Percent change Interval 0.0 to 87.4

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Treatment Arm n=40 participants at risk Tofacitinib (5 mg tablet taken by mouth twice a day) for 3 months.
Gastrointestinal disorders Abdominal pain	5.0% 2/40
Skin and subcutaneous tissue disorders Acne	5.0% 2/40
Eye disorders Conjunctivitis	2.5% 1/40
Respiratory, thoracic and mediastinal disorders Cough	2.5% 1/40
Gastrointestinal disorders Diarrhoea	5.0% 2/40
Eye disorders Dry eyes	2.5% 1/40
General disorders Fatigue	5.0% 2/40
Skin and subcutaneous tissue disorders Folliculitis	2.5% 1/40
Nervous system disorders Headache	5.0% 2/40
Endocrine disorders Hot flashes	2.5% 1/40
Gastrointestinal disorders Nausea	2.5% 1/40
General disorders Numbness	2.5% 1/40
Infections and infestations Paronychia	2.5% 1/40
Skin and subcutaneous tissue disorders Pruritus	5.0% 2/40
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	10.0% 4/40
Infections and infestations Urinary tract infection	2.5% 1/40

Stanford University