Delgocitinib Cream Shows Promise in Treating Adolescents with Chronic Hand Eczema

Results from the phase 3 DELTA TEEN clinical trial showed that delgocitinib cream can effectively treat moderate-to-severe chronic hand eczema (CHE) in adolescents, without raising any safety concerns in the pediatric population. Findings from the multicenter study were presented at the 2025 Fall Clinical Dermatology Conference in Las Vegas. 

CHE is a common inflammatory skin disease that can present with debilitating pain and pruritus, resulting in loss of sleep, impairment of daily activities, and a significant psychosocial burden. Managing this disease in adolescents continues to pose challenges in clinical practice, as there are no therapies approved specifically for the treatment of moderate-to-severe CHE in this population. Topical corticosteroids are used as the first-line treatment for CHE in adolescents. However, the long-term use of these agents raises safety concerns, particularly in pediatric patients, whose sensitive skin is more susceptible to the side effects of corticosteroids and may sustain permanent damage. 

    Delgocitinib, a pan-Janus kinase (JAK) inhibitor that blocks all four members of the JAK family (JAK 1-3 and tyrosine kinase 2), is the first topical therapy specifically approved for adults with moderate-to-severe CHE. Delgocitinib suppresses the overactivation of the skin’s inflammatory response and may improve skin barrier function by suppressing the JAK/Signal Transducer and Activator of Transcription 3 (JAK/STAT3) signaling pathway, which plays a key role in the pathogenesis of CHE. In the DELTA 1 and DELTA 2 phase 3 clinical trials, delgocitinib achieved significant improvement in all efficacy endpoints versus cream vehicle in adults with moderate-to-severe CHE, and was well tolerated when used long-term. 

    DELTA TEEN was a randomized, double-blind, vehicle-controlled, phase 3 clinical trial that enrolled adolescents (aged 12 to 17 year old) with moderate-to-severe CHE. Participants were randomized 3 to1 to twice daily applications of delgocitinib cream 20 mg/g or cream vehicle for 16 weeks, followed by a 2-week safety follow-up period. Similarly to the pivotal DELTA 1 and DELTA 2 trials conducted in adults, investigators set a primary endpoint of 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 at least a two-step improvement from baseline. The results showed that higher proportions of patients treated with delgocitinib cream achieved the primary endpoint of IGA-CHE treatment success, as well as all key secondary endpoints, at week 16. Key secondary endpoints included improvements in CHE severity scores, itch scores, and pain scores. 

    The researchers also evaluated laboratory values, vital signs, and physical presentation to assess the incidence of adverse events (AEs). The results showed that, overall, delgocitinib cream was well-tolerated, and no safety concerns were identified. While the overall rate of AEs was slightly higher for delgocitinib cream 20 mg/g than for cream vehicle, this difference was driven by the reporting of more single events in the group of patients treated with delgocitinib cream than in those who applied cream vehicle. AEs were mild or moderate in severity, and no serious events or deaths were reported. There were no clinically relevant changes or differences in vital signs, physical examination, ECG, biochemistry, hematology, or urinalysis parameters between the treatment groups, and the rates of delgocitinib discontinuation due to AEs were low. 

    “Treatment was well-tolerated, and no safety concerns were identified,” the authors concluded. “These data support the benefits of delgocitinib cream as an efficacious and well tolerated topical treatment in adolescents with moderate to severe CHE.” While delgocitinib cream has been approved for adults with moderate-to-severe CHE in several regions, including the United States, Europe, and the United Kingdom, it has yet to be sanctioned for the treatment of this disease in adolescents.