NCT05682859

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jacob Pontoppidan Thyssen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hand Eczema

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-25
• Primary completion: 2025-04-01
• Completion: 2026-04-01
• First posted: 2023-01-12
• Last updated: 2023-11-18

Locations

1 site across 1 country: Denmark