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Treatment of Chronic Hand Eczema with Oral Roflumilast (HERO)
EU CTIS ID: 2022-503011-42-00
What this study is testing
To investigate the efficacy and safety of roflumilast (PDE4-inhibitor) in adult patients with chronic hand eczema (CHE).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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))
You likely can't join if
- Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
- Current treatment with topical antibiotics at screening
- Diagnosis of contact eczema of clinical significance 3 months before randomization
- Previous treatment with apremilast (Otezla®) or roflumilast (Daxas®)
- Confirmed pregnancy
- Breast feeding
See the full eligibility 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
- Severe immunological disease, e.g. HIV, systemic lupus, and systemic sclerosis
- Current treatment with topical antibiotics at screening
- 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
- 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 (wash-out period) and during study after week 4
- Systemic therapy for chronic hand eczema 28 days before randomization (wash-out period) and during study
- Current treatment with oral dicloxacillin or macrolide at screening
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.