Chronic Hand Eczema
Conditions
Brief summary
To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249 ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.
Interventions
DRUGLEO 124249 ointment
Ointment
Ointment vehicle
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of chronic hand eczema with or without atopic etiology/background with a history of not adequately controlled disease activity with cutaneously applied steroid * Physician's Global Assessment of disease severity graded as at least mild at Visit 1 * In overall good health including well controlled diseases
Exclusion criteria
* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin) or corticosteroids within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used). * PUVA (Psoralen Ultraviolet A) or UVB (Ultraviolet B) therapy on the hands within 4 weeks prior to randomization * Cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks prior to randomization. * Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks prior to randomization * Concurrent skin diseases on the hands * Current diagnosis of exfoliative dermatitis * Significant clinical infection (impetiginized hand eczema) on the hands which requires antibiotic treatment * A marked abnormal ECG at baseline * Known hepatic dysfunction or hepatic dysfunction tested at Screening * Current participation in any other interventional clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects with treatment success according to Physician's Global Assessment (PGA) at visit 6 (End of Treatment) | 56 days | Treatment success according to the PGA is defined as: Subjects having mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or almost clear |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand Eczema Severity Index (HECSI) at visit 6 | 56 days | — |
| Subjects with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at visit 6 (End of Treatment) | 56 days | Treatment success according to the PaGA is defined as: Subjects having very mild or mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or very mild |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORMargitta Worm, Prof Dr
Allergie-Centrum-Charité Klinik für Dermatologie, Venerologie und Allergologie
Outcome results
None listed