drugset / Trial / NCT03683719
Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.
Timeline
- Start
- 2018-11-28
- Primary completion
- 2020-03-06
- Completion
- 2020-04-20
Publications
- Buhl T, Bauer A, Ehst BD, Thyssen JP, Hahn-Pedersen J, Hagen BF, Apol ED, Agner T. Health-Related Quality of Life in Chronic Hand Eczema in a Phase 2b Trial of Delgocitinib Cream. Dermatol Ther (Heidelb). 2025 May;15(5):1181-1193. doi: 10.1007/s13555-025-01384-4. Epub 2025 Apr 5.
- Weisshaar E, Yuksel YT, Agner T, Larsen LS, Grant L, Arbuckle R, Jones AM, Fromy P, Balita-Crisostomo CL, Mathiasen NN, Thoning H, Apfelbacher C. Development and Validation of a Patient-Reported Outcome Measure of the Impact of Chronic Hand Eczema on Health-Related Quality of Life: the Hand Eczema Impact Scale (HEIS). Dermatol Ther (Heidelb). 2024 Nov;14(11):3047-3070. doi: 10.1007/s13555-024-01267-0. Epub 2024 Oct 21.
- 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 | 1 unknown | Topical |
| Subject | Delgocitinib | Small molecule | 3 unknown | Topical |
| Subject | Delgocitinib | Small molecule | 8 unknown | Topical |
| Subject | Delgocitinib | Small molecule | 20 unknown | Topical |
Indications
No indication recorded.