Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema

Summary

The purpose of this trial is to test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. At each visit to the clinic, the doctor will assess the severity and extent of CHE, and during the trial, the adolescents will assess their CHE signs and symptoms as well as quality of life. The trial will last up to 22 weeks and has a 1-4 week screening period, a 16-week treatment period and a 2- week follow-up period. During the treatment period, each adolescent participant will use either the delgocitinib cream or cream vehicle twice daily.

Timeline

Start

2022-07-14

Primary completion

2024-12-05

Completion

2024-12-17

Outcome

Met primary endpoint

paper Superiority of delgocitinib cream to cream vehicle was shown for the primary endpoint (IGA-CHE treatment success at week 16). PMID 42235562 ↗

paper 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 PMID 42235562 ↗

Publications

• Molin S, Baselga E, Navarro-Trivino FJ, Reguiai Z, Schepper S, Halpern J, Marcoux D, Su JC, Brzewski P, Antonsen SD, Hiort LC, Sohoel A, Thogersen P, Rubel D. 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 Jun 3:S2352-4642(26)00098-2. doi: 10.1016/S2352-4642(26)00098-2. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delgocitinib	Small molecule	20 unknown	Topical

Indications

No indication recorded.