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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

Criteria

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