Korean Post Marketing Surveillance for Litfulo Capsule in Severe Alopecia Areata

What this Trial Is About

Researchers are observing the safety and effects of Litfulo Capsule for people with severe alopecia areata. The study aims to monitor this medicine's safety after it has been marketed, focusing on various types of adverse events, including serious infections, opportunistic infections, herpes zoster, and malignancy. This observational study is conducted in routine clinical practice to gather important safety information about Litfulo. Participants who have been prescribed Litfulo Capsule for severe alopecia areata according to approved indications will be followed. The study collects data during two surveillance periods: a regular surveillance over 24 weeks and a long-term surveillance up to 48 weeks. Researchers will record the frequency and proportion of adverse events, serious adverse events, and adverse events of special interest during these times. Participants will be monitored through routine clinical practice visits where safety data will be collected. The main measurements include the occurrence of adverse events and the improvement of alopecia severity using the Severity of Alopecia Tool (SALT) scores at weeks 24 and 48. This study involves patients aged 12 years and older and will continue until March 2030, assessing both safety and treatment effects in real-world settings.

A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.