Real-World Trial Shows Oral Alitretinoin Effective for Severe Hand Eczema

Patients with severe, treatment-resistant hand eczema in Korea continued to see clear skin well beyond the end of active treatment, with 60.87% achieving clear or nearly clear status after 36 weeks vs 42.64% at treatment completion, according to a real-world trial published in Annals of Dermatology.¹

A Therapy Without a US Foothold

Chronic hand eczema (CHE) is a debilitating dermatologic condition that often proves refractory to topical corticosteroids (TCS), leaving clinicians with few systemic options once first-line topical therapy fails. Oral alitretinoin has demonstrated efficacy for severe CHE in clinical trials and is approved for this indication across Europe, Canada, and other markets. It remains without FDA approval, limiting its availability to American patients and leaving a gap that other systemic options (such as off-label immunosuppressants) attempt to fill.²

Despite alitretinoin's international approval history, real-world, multicenter data on its performance in Korean patients had remained limited. Investigators designed a prospective, investigator-initiated trial to evaluate its real-world efficacy and safety in this population.¹

The multicenter, prospective, open-label, single-arm study enrolled 146 patients with severe CHE who had an insufficient response to TCS at tertiary hospitals across Korea. All enrolled patients met the “severe” criteria on the Physician's Global Assessment (PGA) at baseline, and the most common clinical subtype was hyperkeratotic CHE (78.77%), followed by vesicular (11.64%) and fingertip (6.85%) presentations.

Patients received oral alitretinoin at 30 mg once daily, with dose reduction to 10 mg permitted, for up to 24 weeks, followed by observation through week 36. The primary end point was achievement of “clear” or “almost clear” status on the PGA at treatment completion, with the modified total lesion symptom score and Patient's Global Assessment (PaGA) serving as secondary endpoints. Efficacy analyses were conducted on the full analysis set of 129 patients, while safety was assessed in 134 patients.

Response Rates Climbed Well Past Treatment Completion

At treatment completion, 55 patients (42.64%) had achieved a PGA response of clear or almost clear. That figure undersold the drug's full effect: improvement climbed steadily from just 1.83% at week 4 to 60.87% by week 36, well beyond the active treatment window, and among responders with available follow-up data, no relapse to a severe PGA score was observed through week 36. Patient-reported outcomes followed a similar trajectory, with 17.32% reporting “clear or almost clear” and another 28.35% reporting “marked improvement” on the PaGA at treatment completion. Objective lesion scores improved by 62.3% at treatment completion and by 75.7% at week 36. In the safety analysis of 134 patients, 44.03% experienced adverse events, most commonly headache, reported by 29.10%. Two serious adverse events occurred (appendicitis and interstitial lung disease), neither of which was judged related to alitretinoin.

“Oral 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,” the authors wrote.

No Comparator Arm

As an open-label, single-arm study without a placebo or active comparator, the trial cannot rule out that some of the continued improvement observed after treatment completion reflects natural disease fluctuation or regression to the mean rather than a durable drug effect. The analysis also permitted dose reduction from 30 mg to 10 mg during the study, which, while reflecting real-world prescribing flexibility, makes it harder to attribute outcomes to a single, consistent dosing regimen.

For US clinicians and payers, the data add to the real-world evidence base for a drug not currently available domestically, underscoring both the unmet need for systemic options in severe, TCS-refractory hand eczema and the continued relevance of alitretinoin access discussions as more real-world data accumulate internationally.

References

1. Kwon MJ, Yu JW, Han B, et al. 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. Ann Dermatol. 2026;38(4):274-281. doi:10.5021/ad.25.242
2. European Medicines Agency. Toctino: EPAR - Product Information. Accessed October 1, 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/toctino