drugset / Trial / NCT06797310

Evaluating the Effectiveness and Tolerance of Baricitinib in the Treatment of Acute Alopecia Areata With Active Hair Shedding: A Prospective Open-Label Study

NCT06797310

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-01-23
Primary completion
2025-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Baricitinib Small molecule 4 mg

Indications