Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial
Jacob Pontoppidan Thyssen
40 participants
Sep 25, 2023
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
Inclusion Criteria8
- 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 Criteria18
- 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
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Interventions
Randomized to either systemic roflumilast or placebo in phase 1. All participating patients will receive roflumilast in phase 2.
Placebo tablets
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05682859