Treatment for chronic hand eczema using oral roflumilast
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial
This study is testing if the medication roflumilast can help adults with chronic hand eczema feel better and improve their skin condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05682859 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of roflumilast, a PDE4-inhibitor, in adult patients suffering from chronic hand eczema. The study is designed as a multicenter, double-blinded, randomized, placebo-controlled trial, followed by an open-label extension phase. Participants will receive either roflumilast or a placebo for 16 weeks, after which all participants will receive roflumilast for an additional 12 weeks. The primary outcomes include improvements in eczema severity and potential changes in the skin microbiome, as well as secondary outcomes related to lung function and weight loss.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with moderate to severe chronic hand eczema.
Not a fit: Patients with severe immunological diseases, current tuberculosis, or a history of significant liver or heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with chronic hand eczema by reducing symptoms and enhancing skin health.
How similar studies have performed: Other studies have shown promise with PDE4-inhibitors for various inflammatory conditions, suggesting potential success for this approach in treating chronic hand eczema.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Copenhagen
- Department of dermatology and veneorology, Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Jacob P Thyssen, Professor, MD, DMSc
- Email: jacob.pontoppidan.thyssen@regionh.dk
- Phone: 38636173
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.