Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial
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.
• Age ≥ 18 years
• HECSI ≥ 18 (moderate to severe hand eczema)
• IGA-CHE ≥ 3
• Body mass index (BMI) ≥ 20 kg/m2
• Negative 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 potential
• Speaks, understands, and reads danish.