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Clinical trial

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

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Last updated:12th Jun 2024
Status: RECRUITING
Identifier: NCT05682859
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)


ClinicalTrials.gov ID: NCT05682859

Sponsor: Jacob Pontoppidan Thyssen
Information provided by: Jacob Pontoppidan Thyssen, Bispebjerg Hospital (Responsible Party)
Last Update Posted: 2023-11-18

Brief 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.

Detailed Description:
This study will investigate the efficacy and safety of roflumilast in adult patients with CHE and it is hypothesized that patients treated with oral roflumilast (500 microgram once daily) will experience an improvement in their moderate-to-severe CHE (measured by hand eczema severity index (HECSI)) and alter the skin microbiome. Secondly, it is hypothesized that patients treated with oral roflumilast will experience improved lung function and weight loss.

This study includes two phases:

- Phase 1: 20 patients will receive 500 microgram tablet of roflumilast once daily for 16 weeks while 20 patients will receive placebo once daily for 16 weeks.
- Phase 2: All 40 patients from phase 1 will receive 500 microgram tablet of roflumilast once daily for 12 weeks.

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

Intervention / Treatment: 
- Drug: Roflumilast 500 Mcg Oral Tablet
- Drug: Placebo

Category Value
Study Start (Actual) 2023-09-25
Primary Completion (Estimated) 2025-04-01
Study Completion (Estimated) 2026-04-01
Enrollment (Estimated) 40
Study Type Interventional
Phase Phase 4
Other Study ID Numbers
MC-HE-RO

2022-503011-42-00 (Other Identifier) (OTHER: EU trial number)


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