LEO19123 Cream in the Treatment of Hand Eczema

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the efficacy and safety of two different dose combinations of LEO19123 cream (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of patients with hand eczema.

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

Details

• Lead Sponsor: LEO Pharma
• Treatments: Calcipotriene

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).