Presented at ISAD 2025 in Melbourne, the phase 3 findings strengthen evidence for the non-steroidal cream delgocitinib across age groups.
Delgocitinib cream, a non-steroidal topical pan-JAK inhibitor, is both effective and well-tolerated in adolescents with moderate to severe chronic hand eczema, a phase 3 clinical trial has demonstrated.
The DELTA TEEN trial, conducted by an international team of dermatology researchers, evaluated the cream’s efficacy and safety in patients aged 12 to 17 years.
The results were presented at The International Society of Atopic Dermatitis’s 15th Georg Rajka International Symposium on Atopic Dermatitis, held in Melbourne on the weekend.
Chronic hand eczema is a persistent inflammatory skin condition marked by itching, pain and considerable physical and psychosocial distress.
Delgocitinib cream 20 mg/g is already approved in Australia, Europe and other regions for adults with moderate to severe CHE.
The DELTA TEEN study aimed to extend these findings to adolescent patients, and builds on the DELTA 1 and DELTA 2 phase 3 trials that were published in The Lancet last year.
In these randomised, double-blinded, and vehicle-controlled trials conducted at over 100 trial centres in Canada, France, Germany, Italy, Poland, the UK, Belgium, the Netherlands and Spain.
Adults aged 18 years and over with moderate to severe chronic hand eczema were randomly assigned 2:1 to twice daily delgocitinib cream 20 mg/g or cream vehicle for 16 weeks.
“Overall, delgocitinib cream showed superior efficacy versus cream vehicle and was well tolerated over 16 weeks,” the authors wrote.
“These results support the clinical benefit of delgocitinib cream as a potential treatment option for patients with moderate to severe chronic hand eczema, who are unable to adequately control their disease with basic skin care practices and topical corticosteroids.”
In this latest randomised, double-blind, vehicle-controlled, multicentre phase 3 trial presented at the symposium, 98 adolescents were assigned in a 3:1 ratio to receive either delgocitinib cream (N=74) or a cream vehicle (N=24) applied twice daily for 16 weeks, followed by a two-week safety follow-up.
The primary endpoint was treatment success based on the Investigator’s Global Assessment for CHE (IGA-CHE TS) at Week 16, defined as achieving a clear or almost clear rating with at least a two-step improvement from baseline.
Results showed that 63.5% of patients treated with delgocitinib cream achieved treatment success compared with 29.2% in the vehicle group, demonstrating clear superiority.
The cream also outperformed the vehicle in all key secondary measures, including a 90% or greater improvement in the Hand Eczema Severity Index (HECSI-90) and reductions of at least four points in Hand Eczema Symptom Diary (HESD) scores for itch, pain and total symptom burden.
Specifically, HECSI-90 responders were 71.6% for delgocitinib versus 37.5% for vehicle, while itch, pain and total score improvements reached 64.8%, 63.3% and 55.6% respectively for delgocitinib users, compared with 36.8%, 33.3% and 31.3% in the control group.
No serious adverse events were reported, and all adverse events related to delgocitinib cream were mild or moderate.
Although the overall rate of reported adverse events was slightly higher in the treatment group (50.0%) than in the vehicle group (33.3%), the frequency of events considered related to the study drug or leading to withdrawal was lower with delgocitinib, the researchers reported.
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“Delgocitinib cream 20 mg/g demonstrated superior efficacy compared to cream vehicle and was well tolerated in adolescents with moderate to severe CHE, with no safety concerns identified over 16 weeks of treatment,” they concluded.
Findings from the DELTA TEEN trial were also presented at the EADV Congress in Paris in September.
“Chronic hand eczema is very common and is a problematic disease for those living with it, and particularly our adolescent patients,” co-author Professor Sonja Molin, associate professor and division chair for Dermatology, Queen’s University and Kingston Health Sciences Centre, Canada told the congress.
“Currently this no therapy approved specifically for the treatment of moderate to severe chronic health eczema in adolescents.
“First-line medical treatment in adolescents is topical steroids, which we all know can come with problems, particularly in the longer term, and particularly in our paediatric populations, our younger patients who have thinner more sensitive skin.”
The Georg Rajka International Symposium was created by the Norwegian dermatologist of Hungarian origin Georg Rajka in Oslo, in 1979. The conference is not held every year, but this year marked its 15th gathering.
The abstract book from the Melbourne symposium is available here.
There will be another symposium in Beijing, China next year, followed by Augsburg, Germany in 2027.
