Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema
Summary
This was a 16-week study in adult participants with chronic hand eczema (CHE). \> The participants visited the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. \> The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.
Timeline
- Start
- 2021-05-10
- Primary completion
- 2022-10-31
- Completion
- 2022-10-31
Outcome
Met primary endpoint
registry analysis (superiority test); Delgocitinib Cream 20 mg/g vs Cream Vehicle; p = 0.006; NCT04871711 ↗
paper At week 16, a greater proportion of delgocitinib-treated patients versus cream vehicle patients had IGA-CHE treatment success PMID 39033766 ↗
release “DELTA1 trial for delgocitinib, a topical pan-JAK inhibitor for treatment of chronic hand eczema, meeting primary and all key secondary endpoints.” leo-pharma.com ↗
Publications
- Results Bissonnette R, Warren RB, Pinter A, Agner T, Gooderham M, Schuttelaar MLA, Crepy MN, Stingeni L, Serra-Baldrich E, Baranowski K, Korn S, Kurvits M, Plohberger U, Strange Vest N, Schliemann S; trial investigators. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024 Aug 3;404(10451):461-473. doi: 10.1016/S0140-6736(24)01027-4. Epub 2024 Jul 18.
- Bauer A, Guenther L, Woolf R, Didriksen Apol E, Maslin D, Nyholm N, Thoning H, Schuttelaar ML. Effect of Delgocitinib Cream on Health-Related Quality of Life in Patients With Moderate to Severe Chronic Hand Eczema. Contact Dermatitis. 2026 Jul;95(1):91-99. doi: 10.1111/cod.70114. Epub 2026 Mar 3.
- Cohen D, Bewley A, Wollenberg A, Hong HC, Armstrong A, Jonsen E, Maslin D, Thoning H, von Eyben R, Chovatiya R. Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. Dermatol Ther (Heidelb). 2026 Jan;16(1):423-436. doi: 10.1007/s13555-025-01592-y. Epub 2025 Nov 15.
- Silverberg JI, Agner T, Baranowski K, Plohberger U, Thoning H, Arbuckle R, Grant L, Skingley G, Bissonnette R. Validation of the Investigator Global Assessment of Chronic Hand Eczema (IGA-CHE): a new clinician reported outcome measure of CHE severity. Arch Dermatol Res. 2024 Mar 20;316(4):110. doi: 10.1007/s00403-024-02818-3.
- Molin S, Larsen LS, Joensson P, Oesterdal ML, Arbuckle R, Grant L, Skingley G, Schuttelaar MLA. Development and Psychometric Validation of a Patient-Reported Outcome Measure to Assess the Signs and Symptoms of Chronic Hand Eczema: The Hand Eczema Symptom Diary (HESD). Dermatol Ther (Heidelb). 2024 Mar;14(3):643-669. doi: 10.1007/s13555-024-01114-2. Epub 2024 Mar 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Delgocitinib | Small molecule | 20 unknown | Topical |
Indications
No indication recorded.