Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial

BACKGROUND: Chronic hand eczema is a multifactorial, inflammatory skin disease associated with itch, pain, and a substantial physical and psychosocial burden. Delgocitinib cream (2%, 20 mg/g), a topical, non-steroidal, pan-Janus kinase inhibitor, is approved for the treatment of moderate to severe chronic hand eczema in adults. We aimed to assess the efficacy and safety of delgocitinib cream in adolescents with moderate to severe chronic hand eczema. METHODS: DELTA TEEN was a double-blind, vehicle-controlled, multicentre, phase 3 randomised controlled trial conducted at 29 trial sites in Australia, Belgium, Canada, France, Poland, Spain, and the UK. Adolescents (aged 12-17 years) with moderate to severe chronic hand eczema were randomly assigned 3:1 via an interactive response technology system to twice-daily application of delgocitinib cream or cream vehicle for 16 weeks. The primary endpoint was the Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) treatment success at week 16, defined as an IGA-CHE score of 0 or 1 (clear or almost clear) with a 2 step or greater improvement from baseline. Efficacy of delgocitinib cream versus cream vehicle was assessed in all randomly assigned patients exposed to trial treatment, and safety was assessed in all patients exposed to trial treatment. This trial is registered with clinicaltrials.gov, NCT05355818, and is complete. FINDINGS: DELTA TEEN was conducted between July 14, 2022, and Dec 17, 2024. Patients (N=98, of whom 58 59% were female and 40 41% were male, and 89 (91%) patients were White) were randomly assigned to delgocitinib cream (n=74) or cream vehicle (n=24). Superiority of delgocitinib cream to cream vehicle was shown for the primary endpoint (IGA-CHE treatment success at week 16). 47 (64%) of 74 of patients treated with delgocitinib versus seven (29%) of 24 patients treated with the cream vehicle had IGA-CHE treatment success at week 16 (difference 37·9%; 95% credibility interval 13·5-58·2). Adverse events were reported by 37 (50%) patients treated with delgocitinib and eight (33%) patients treated with the cream vehicle. All adverse events with delgocitinib cream were mild or moderate in severity. No serious adverse events were reported in either group. INTERPRETATION: Delgocitinib cream showed superior efficacy compared with cream vehicle and was well tolerated over 16 weeks. The results support delgocitinib cream as a treatment option for adolescents with moderate to severe chronic hand eczema. FUNDING: LEO Pharma.