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COMPLETED
NCT05682859
PHASE4

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

Sponsor: Jacob Pontoppidan Thyssen

View on ClinicalTrials.gov

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.

Official title: Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2023-09-25

Completion Date

2025-09-01

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

DRUG

Roflumilast 500 Mcg Oral Tablet

Randomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2.

DRUG

Placebo

Placebo tablets

Locations (1)

Department of dermatology and veneorology, Bispebjerg Hospital

Copenhagen, Denmark