Proof of Concept, Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema

This is an interventional treatment trial for Hand Eczema Read More

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