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

A Phase 2a, Proof of Concept Trial, Testing Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema

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.

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