Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)
Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)
ClinicalTrials.gov ID: NCT05355818
Sponsor: LEO Pharma
Information provided by: LEO Pharma (Responsible Party)
Last Update Posted: 2024-05-31
Brief Summary:
The purpose of this trial is to test if delgocitinib cream is effective at treating chronic hand eczema (CHE) and what side effects it may have, in children aged 12-17. There will be a range of assessments that rate the severity and extent of CHE symptoms, general health and quality of life.
Delgocitinib is a cream that suppresses specific processes in the body's response to diseases like CHE, such as inflammation.
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 child will use either delgocitinib cream or a cream vehicle twice a day. Which cream each child receives is chosen randomly by a computer. The cream vehicle is made of the same ingredients as the delgocitinib cream except for the active medical ingredient. There will be 8 visits with the trial doctor.
Official Title:
A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
Intervention / Treatment:
- Drug: Delgocitinib
- Drug: Cream vehicle
| Category | Value |
|---|---|
| Study Start (Actual) | 2022-07-14 |
| Primary Completion (Estimated) | 2024-12-03 |
| Study Completion (Estimated) | 2024-12-17 |
| Enrollment (Estimated) | 92 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
LP0133-1426
2021-006340-27 (EudraCT Number) |