LEO19123 Cream in the Treatment of Hand Eczema

Launched by LEO PHARMA · Nov 27, 2006

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of hand eczema with or without atopic etiology/background
• • Investigator.s Global Assessment of disease severity graded as at least mild at Visit 1
• • Patients should be Caucasian males aged from 18 years
• • Attending a hospital outpatient clinic or the private practise of a dermatologist.
• • Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any trial related activity is carried out, including activities relating to wash-out periods.
• 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).