Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO) (NCT05682859) | Clinical Trial Compass
UnknownPhase 4
Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)
Denmark40 participantsStarted 2023-09-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
What they're measuring
1
Proportion of patients achieving at least 75% reduction in hand eczema severity index (HECSI75) at week 16 when compared to HECSI at baseline.
Timeframe: Through study completion, an average of 28 weeks