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Chronic hand eczema is a multifactorial inflammatory skin disorder characterized by persistent itch, pain, and considerable physical and psychosocial burden.
Delgocitinib cream efficiently improves chronic hand eczema clearance in adolescents and remains well-tolerated over 16 weeks.
Chronic hand eczema is a multifactorial inflammatory skin disorder characterized by persistent itch, pain, and considerable physical and psychosocial burden. Delgocitinib cream 2% (20 mg/g), a non-steroidal pan-Janus kinase inhibitor, is approved for adults with chronic hand eczema. However, evidence supporting its use in adolescents has been limited. Hence, this trial explored the safety and potency of delgocitinib cream.
DELTA TEEN was a phase 3 randomized controlled trial conducted across 29 sites in Australia, Belgium, Canada, France, Poland, Spain, and the UK. Adolescents aged 12–17 years with moderate-to-severe persistent hand eczema were randomized in a 3:1 ratio to receive twice-daily delgocitinib cream or cream vehicle for about 16 weeks.
The key outcome was Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) treatment success at week 16. It was described as an IGA-CHE score of 0 or 1 (clear or almost clear) together with a minimum of a two-step betterment from the baseline. Efficacy analyses included all randomized patients exposed to treatment, while safety assessments included all treated participants.
A total of 98 adolescents were enrolled, including 58 females (59%) and 40 males (41%); 89 participants (91%) were White. Overall, 74 patients received delgocitinib cream and 24 received vehicle cream. Delgocitinib achieved the primary endpoint and demonstrated superiority over vehicle at week 16. The treatment was generally well-tolerated, with adverse events being mild to moderate in severity and no serious safety concerns reported (Table 1):
For chronic hand eczema, delgocitinib cream illustrated superior potency compared with vehicle cream and was well-tolerated for over 16 weeks. The treatment achieved higher rates of IGA-CHE success without serious safety concerns.
The Lancet Child & Adolescent Health
Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial
Prof Sonja Molin et al.
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