A Multi-Center, Open-Label, Single-Arm, Prospective Investigator Initiated Trial to Evaluate the Efficacy and Safety of Alitretinoin in Patients With Chronic Hand Eczema in Real-World Practice (DWALG_P401) and Overview of Korean Studies.

backgroundChronic hand eczema (CHE) is a debilitating dermatologic condition often refractory to topical corticosteroids (TCS). Although oral alitretinoin has demonstrated efficacy in CHE, real-world multicenter data in Korean populations remain limited.

objectiveTo evaluate the real-world efficacy and safety of oral alitretinoin in Korean patients with severe CHE with insufficient response to TCS.

methodsThis multicenter, prospective, open-label study enrolled 146 patients with severe CHE at tertiary hospitals in Korea. Patients received oral alitretinoin (30 mg once daily, with dose reduction to 10 mg permitted) for up to 24 weeks, with observation up to 36 weeks. The primary endpoint was achievement of "clear" or "almost clear" on the Physician's Global Assessment (PGA) at treatment completion. Secondary endpoints included the modified total lesion symptom score (mTLSS) and Patient's Global Assessment (PaGA). Safety was evaluated by monitoring adverse events (AEs) and laboratory abnormalities. Efficacy analyses were performed on the full analysis set (n=129).

resultsAt treatment completion, 55 patients (42.64%) achieved a PGA response. Improvement increased from week 4 (1.83%) to week 36 (60.87%). PaGA showed consistent improvement, with 17.32% reporting "clear or almost clear" and 28.35% reporting "marked improvement" at treatment completion. mTLSS scores improved by 62.3% at treatment completion and by 75.7% at week 36. In the safety analysis (n=134), 44.03% experienced AEs, most commonly headache (29.10%).

conclusionOral alitretinoin at daily doses of 10 mg or 30 mg demonstrated effective symptom improvement and an acceptable safety profile in Korean patients with CHE in a real-world setting.