drugset / Trial / NCT05682859

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

NCT05682859

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

EvaluationDrugModalityDoseRoute
Comparator Roflumilast Small molecule 500 ug Oral

Indications

No indication recorded.