Status:
COMPLETED
LEO19123 Cream in the Treatment of Hand Eczema
Lead Sponsor:
LEO Pharma
Conditions:
Hand Eczema
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 eczem...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2007
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00404196
Start Date
October 1 2006
End Date
March 1 2007
Last Update
February 24 2025
Active Locations (1)
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1
Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH