Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-24 @ 2:42 PM
NCT ID:
NCT05682859
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05682859
Study Brief:
Protocol Section:
NCT05682859