NCT05682859CompletedPhase 4
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) - a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 41 (actual)
- First submitted
- 16 Dec 2022
- Start date
- 25 Sept 2023
- Primary completion date
- 17 Jun 2025
- Lead sponsor
- Jacob Pontoppidan Thyssen
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT05682859
- EU CT number
- 2022-503011-42-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 41
- From 25 Sept 2023 to the primary completion date, 17 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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®)
Other illness
- 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)
- Allergy to roflumilast or any other PDE-4 inhibitor
Other
- Current or former depression with suicidal ideation
- Confirmed pregnancy
- Breast feeding
- Blood donation during study
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of dermatology and veneorology, Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.