LEO19123 Cream in the Treatment of Hand Eczema

Exclusion Criteria

• •Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intranasal steroids for asthma or rhinitis may be used).
• •PUVA or UVB therapy on the hands within 4 weeks prior to randomisation.
• •Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from WHO groups III or IV on the hands within 2 weeks prior to randomisation.
• •Other topical therapy on the hands (except for the use of emollient) within 1 week prior to randomisation.
• •Use of other treatment (drug, non-drug) on the hands during the trial except for the use of investigational product and emollient.
• •Concurrent skin diseases on the hands.
• •Current diagnosis of exfoliative dermatitis.
• •Significant clinical infection (impetiginised hand eczema) on the hands, which requires antibiotic treatment.
• •Known or suspected hypersensitivity to component(s) of the investigational product.
• •Positive patch test as defined in protocol
• •Known or suspected severe renal insufficiency or severe hepatic disorders.
• •Patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia.
• •Patients with history of cancer except for basal cell carcinoma.
• •Current participation in any other interventional clinical trial.
• •Patients who have received treatment with any nonmarketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation.
• •Previously randomised in this study.
• •Patients known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, or psychotic state).