Hand Eczema
Conditions
Brief 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.
Interventions
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proof of concept | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
Countries
United Kingdom
Outcome results
None listed