NCT02664805.

Trial name or title	Proof of concept, twice daily applications of LEO 124249 ointment in the treatment of chronic hand eczema Official title: A phase 2a, proof of concept trial, testing twice daily applications of LEO 124249 ointment in the treatment of chronic hand eczema
Methods	Randomised double‐blind vehicle‐controlled parallel‐group study
Participants	91 patients with chronic hand eczema Inclusion criteria Clinical diagnosis of chronic hand eczema with or without atopic aetiology/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 disease Exclusion criteria Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), retinoids (e.g. alitretinoin), or corticosteroids within 6 weeks before randomisation (inhaled or intranasal 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 before randomisation Cutaneously applied treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids on the hands within 2 weeks before randomisation Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 2 weeks before randomisation Concurrent skin disease on the hands Current diagnosis of exfoliative dermatitis Significant clinical infection (impetiginised hand eczema) on the hands that requires antibiotic treatment Markedly abnormal ECG at baseline Known hepatic dysfunction or hepatic dysfunction tested at screening Current participation in any other interventional clinical trial
Interventions	Intervention • LEO 124249 ointment twice‐daily cutaneous application for 8 weeks Control intervention • LEO 124249 ointment vehicle twice‐daily cutaneous application for 8 weeks
Outcomes	Primary outcome of the trial Treatment success according to Physician's Global Assessment (PGA) at end of treatment (8 weeks). Treatment success according to the PGA is defined as follows: subjects having mild disease at baseline must achieve clear. Subjects having moderate or severe disease at baseline must achieve clear or almost clear Secondary outcomes of the trial Hand Eczema Severity Index (HECSI) at end of treatment (8 weeks) Participants with treatment success according to the Patient's Global Assessment of disease severity (PaGA) at end of treatment (8 weeks). Treatment success according to the PaGA is defined as follows: 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
Starting date	February 2016
Contact information	Prof. Dr. Margitta Worm, Allergie‐Centrum‐Charité Klinik für Dermatologie, Venerologie und Allergologie Berlin, Germany 10117
Notes	Sponsor: LEO Pharma