LEO19123 Cream in the Treatment of Hand Eczema (NCT00404196) | Clinical Trial Compass
CompletedPhase 2
LEO19123 Cream in the Treatment of Hand Eczema
United Kingdom75 participantsStarted 2006-10
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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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…