Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

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.

Inclusion Criteria:Age ≥ 18 yearsAge ≤ 75 yearsHECSI ≥ 18 (moderate to severe hand eczema)IGA-CHE ≥ 3Body mass index (BMI) ≥ 20 kg/m2Negative pregnancy test (only women of child-bearing potential (see section 2.8))Willing to use safe anticonception during entire study and at least 1 week after end of treatment (-5 times plasma half-life of Roflumilast). This only account for women child-bearing potentialSpeaks, understands, and reads danish.Exclusion Criteria:Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosisDiagnosis of current tuberculosisCurrent viral hepatitisHistory of heart failure (NYHA III-IV)History of moderate or severe liver failure (Child-Pugh B-C)Current or former depression with suicidal ideationTopical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomizationTopical therapy (anti-inflammatory) for chronic hand eczema during studySystemic therapy for chronic hand eczema 28 days before randomizationSystemic therapy for chronic hand eczema during studyCurrent treatment with oral dicloxacillin or macrolideCurrent treatment with topical antibioticsDiagnosis of contact eczema of clinical significance 3 months before randomizationPrevious treatment with apremilast (Otezla®) or roflumilast (Daxas®)Confirmed pregnancyBreast feedingBlood donation during studyAllergy to roflumilast or any other PDE-4 inhibitor