Delgocitinib Cream Succeeds in First Phase 3 Trial for Teens With Hand Eczema

Nearly two-thirds of adolescents with moderate to severe chronic hand eczema (CHE) achieved clear or almost clear skin after 16 weeks of twice-daily delgocitinib cream (Anzupgo; LEO Pharma), more than double the response seen with vehicle cream, according to results from DELTA TEEN (NCT05355818), the first phase 3 trial to test a CHE treatment exclusively in this age group.¹

No Treatment Approved for Adolescents With This Disease

CHE is a multifactorial inflammatory skin disease of the hands and wrists that persists for more than 3 months or recurs at least twice within a year, causing pain, itch, and visible disfigurement that can lead to embarrassment and social isolation. Delgocitinib cream, a non-steroidal topical pan-Janus kinase inhibitor, is already approved for adults with moderate to severe CHE in more than 37 countries based on the phase 3 DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) trials. However, no treatment has been approved specifically for adolescents with the disease, and topical corticosteroids, the current first-line option, carry safety concerns with prolonged use.

Adolescents may be especially vulnerable to those risks. Children are more sensitive than adults to topical corticosteroids, according to the American Academy of Dermatology, and prolonged use can thin the skin, slow growth, and cause the medication to stop working.² Other options used in practice, including topical calcineurin inhibitors, oral corticosteroids, and cyclosporine, either lack evidence in CHE or carry their own safety concerns, leaving what the researchers called a high unmet medical need for adolescents with the disease.¹

Testing a Nonsteroidal Cream Against Vehicle in a Randomized Trial

DELTA TEEN was a double-blind, vehicle-controlled, multicentre, phase 3 randomized controlled trial conducted at 29 sites across Australia, Belgium, Canada, France, Poland, Spain, and the UK between July 2022 and December 2024. It enrolled 98 adolescents aged 12 to 17 years with moderate to severe CHE, defined by an Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) score of 3 or 4, who had an inadequate response to topical corticosteroids or for whom that treatment was considered medically inadvisable.

Patients were randomly assigned 3: 1 to twice-daily delgocitinib cream (n = 74) or cream vehicle (n = 24) for 16 weeks, using the same dosing regimen approved for adults. Most participants were White (91%) and slightly more than half were female (59%); the most common CHE subtype was atopic hand eczema (66%), followed by irritant contact dermatitis (12%) and allergic contact dermatitis (9%). The primary end point was IGA-CHE treatment success at week 16, defined as a score of 0 or 1 with at least a 2-step improvement from baseline.

Delgocitinib Cream Cleared Skin in Nearly Two-Thirds of Patients

Delgocitinib cream met its primary end point: 64% of patients (47 of 74) achieved IGA-CHE treatment success at week 16, compared with 29% (7 of 24) of those on cream vehicle, a treatment difference of 37.9 percentage points (95% credibility interval, 13.5-58.2). Delgocitinib cream also showed superiority on every key secondary end point, including a 90% improvement in Hand Eczema Severity Index score (72% vs 38%) and reductions of at least 4 points in patient-reported itch, pain, and total symptom scores. Quality of life improved roughly twice as much with delgocitinib cream as with vehicle, measured by the Children's Dermatology Life Quality Index.

“In the DELTA TEEN trial, delgocitinib cream showed superiority compared with the cream vehicle for the primary and all key secondary end points,” the researchers wrote, noting that the results were consistent with the efficacy demonstrated in adults in DELTA 1 and DELTA 2.

Adverse Events Were Mostly Mild, With No Safety Signals

Treatment-emergent adverse events were reported by 50% of patients on delgocitinib cream and 33% on cream vehicle, but every adverse event in the delgocitinib group was mild or moderate in severity, and no serious adverse events or deaths occurred in either group. The most frequent adverse events were nasopharyngitis and headache, occurring at similar rates in both groups. Three patients in each treatment arm discontinued the trial, citing lack of efficacy, adverse events, or, in 1 case in the vehicle group, loss to follow-up.

The researchers noted that DELTA TEEN's 16-week treatment period did not generate long-term safety data in adolescents, though they said extrapolation from up to 52 weeks of safety data in adults, whose safety profile has remained consistent, is reasonable. Other limitations included low diversity in skin type, since the trial population was 91% White, and reduced precision around the vehicle arm's estimates that resulted from the trial's 3-to-1 randomization ratio, a design chosen to limit how many adolescents were assigned to inactive treatment.

With no guidelines or approved treatments yet specific to CHE in adolescents, the researchers said the trial addresses a population that clinicians have had to manage largely by extrapolating from adult data and off-label options. They emphasized that the findings support delgocitinib cream as a nonsteroidal option that could reduce reliance on topical corticosteroids in a group whose thinner, more sensitive skin makes long-term steroid use especially concerning.

References

1. Molin S, Baselga E, Navarro-Triviño FJ, et al. Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial. Lancet Child Adolesc Health. 2026;10:552-561. doi:10.1016/S2352-4642(26)00098-2
2. American Academy of Dermatology. Eczema treatment: corticosteroids applied to the skin. Accessed July 30, 2026. https://www.aad.org/public/diseases/eczema/childhood/treating/corticosteroids-applied-to-skin