RecruitingPhase 4NCT05682859

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

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


Sponsor

Jacob Pontoppidan Thyssen

Enrollment

40 participants

Start Date

Sep 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (HERO) tests whether roflumilast, an oral medication, can reduce inflammation and improve chronic hand eczema — a skin condition causing persistent, uncomfortable redness and rash on the hands. You may be eligible if you: - Are aged 18 to 75 - Have moderate to severe chronic hand eczema (HECSI ≥18, IGA-CHE ≥3) - Have a BMI of at least 20 kg/m² - Are willing to use contraception during the study (if applicable) - Read and understand Danish You may NOT be eligible if you: - Have a severe immune disease (HIV, lupus, systemic sclerosis) - Have active tuberculosis or viral hepatitis - Have or have had depression with suicidal thoughts - Are currently pregnant or breastfeeding - Are allergic to roflumilast Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRoflumilast 500 Mcg Oral Tablet

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

DRUGPlacebo

Placebo tablets


Locations(1)

Department of dermatology and veneorology, Bispebjerg Hospital

Copenhagen, Denmark

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NCT05682859


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