Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jacob Pontoppidan Thyssen
• Collaborator: The Novo Nordic Foundation

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Age ≤ 75 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.

Exclusion Criteria:

• Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis

• Diagnosis of current tuberculosis

• Current viral hepatitis

• History of heart failure (NYHA III-IV)

• History of moderate or severe liver failure (Child-Pugh B-C)

• Current or former depression with suicidal ideation

• Topical therapy (anti-inflammatory) for chronic hand eczema 14 days before randomization

• Topical therapy (anti-inflammatory) for chronic hand eczema during study

• Systemic therapy for chronic hand eczema 28 days before randomization

• Systemic therapy for chronic hand eczema during study

• Current treatment with oral dicloxacillin or macrolide

• Current treatment with topical antibiotics

• Diagnosis of contact eczema of clinical significance 3 months before randomization

• Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®)

• Confirmed pregnancy

• Breast feeding

• Blood donation during study

• Allergy to roflumilast or any other PDE-4 inhibitor