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Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study
Sponsor: National Taiwan University Hospital
Summary
Alopecia areata (AA) in the acute phase with active hair shedding causes significant psychological distress, prompting the need for effective treatment. While baricitinib has shown efficacy in chronic AA with extensive hair loss (SALT ≥ 50), its impact on acute AA remains unclear. Clinical observations suggest that baricitinib can reduce or halt hair shedding within 4-6 weeks, offering a faster response than conventional treatments like systemic corticosteroids. This 16-week, single-center, open-label study aims to evaluate the effectiveness of baricitinib in 30 patients with acute AA and active shedding. Participants will receive 4 mg daily for 16 weeks, with responders tapering to 2 mg for an additional 16 weeks. Follow-up visits will occur at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52. The primary endpoint is achieving an iSARS-AA score of 20 or less at week 16. This study will provide real-world insights into baricitinib's role in managing acute AA.
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-01-23
Completion Date
2026-12-31
Last Updated
2025-01-28
Healthy Volunteers
No
Conditions
Interventions
Baricitinib
This study evaluates the use of baricitinib 4 mg once daily for 16 weeks in patients with acute alopecia areata (AA) experiencing active hair shedding. Unlike prior studies focusing on chronic AA with extensive hair loss (SALT ≥ 50), this intervention targets the acute phase, aiming to halt shedding within 4-6 weeks-faster than conventional treatments like corticosteroids. Patients meeting the primary endpoint (iSARS-AA ≤ 20 at week 16) will taper to 2 mg daily for an additional 16 weeks. Scheduled follow-ups at weeks 0, 4, 8, 12, 16, 24, 32, 36, 44, and 52 ensure comprehensive monitoring, distinguishing this study from others with shorter follow-ups or less frequent assessments.
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan