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Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)
Sponsor: Jacob Pontoppidan Thyssen
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
Conditions
Interventions
Roflumilast 500 Mcg Oral Tablet
Randomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2.
Placebo
Placebo tablets
Locations (1)
Department of dermatology and veneorology, Bispebjerg Hospital
Copenhagen, Denmark