drugset / Trial / NCT05682859
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a multicentre, double-blinded, randomized, placebo-controlled, clinical trial with open-label extension. The purpose and aim of this study is to investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE). Patients will receive 16-week treatment with either roflumilast or placebo tablets. Hereafter, both groups continue in open-label treatment for 12 weeks where both groups will receive treatment with roflumilast.
Timeline
- Start
- 2023-09-25
- Primary completion
- 2025-04-01
- Completion
- 2026-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Roflumilast | Small molecule | 500 ug | Oral |
Indications
No indication recorded.