Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial.

Summary

In a multicentre, assessor-masked phase 3 RCT (n=513), delgocitinib cream achieved a significantly greater HECSI reduction at week 12 than alitretinoin (LS mean change -67.6 vs -51.5; difference -16.1; p<0.0001) with fewer adverse events (49% vs 76%). Headache (4% vs 32%) and nausea (<1% vs 6%) were notably lower with delgocitinib. Results support delgocitinib as an effective and safer option over 24 weeks.

Key Findings

• Greater HECSI improvement with delgocitinib at week 12 (LS mean -67.6) vs alitretinoin (-51.5); difference -16.1 (95% CI -23.3 to -8.9), p<0.0001.
• Fewer patients reported adverse events with delgocitinib (49% of 253) vs alitretinoin (76% of 247).
• Specific AEs were lower with delgocitinib: headache 4% vs 32% and nausea <1% vs 6%.

Clinical Implications

Delgocitinib cream may become a preferred first-line option for severe chronic hand eczema, potentially reducing reliance on systemic retinoids and their adverse effects, and informing updates to treatment guidelines.

Limitations

• Sponsored by the manufacturer, which may introduce bias.
• Comparison limited to alitretinoin; generalisability to other systemic therapies is unknown.

Future Directions

Evaluate long-term remission, relapse prevention, and comparative effectiveness versus other systemic agents and biologics; assess patient-reported outcomes and cost-effectiveness.