Hand eczema MedDRA version: 8.1 Level: PT Classification code 10058898 Term: Hand dermatitis
Conditions
Interventions
Product Code: LEO19123
Pharmaceutical Form: Cream
INN or Proposed INN: Calcipotriol Hydrate
CAS Number: 147657-22-5
Concentration unit:
Sponsors
LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of hand eczema with or without atopic etiology/background 2. Investigator’s Global Assessment of disease severity graded as at least mild at Visit 1 3. Patients should be Caucasian males aged from 18 years 4. Attending a hospital outpatient clinic or the private practise of a dermatologist. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (Inhaled or intra-nasal steroids for asthma or rhinitis may be used) 2. PUVA or UVB therapy on the hands within 4 weeks prior to randomisation 3. Topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticoster -oids from WHO groups III or IV on the hands within 2 weeks prior to randomisation 4. Other topical therapy on the hands (except for the use of emollients) within 1 week prior to randomisation 5. Use of other treatment (drug, non-drug) on the hands during the study except for the use of investigational product and emollient 6. Concurrent skin diseases on the hands 7. Current diagnosis of exfoliative dermatitis 8. Significant clinical infection (impetiginised hand eczema) on the hands which requires antibiotic treatment 9. Known or suspected hypersensitivity to component(s) of the investigational product 10. Positive patch test as defined in section 11.7.4.2 of the protocol. 11. Known or suspected severe renal insufficiency or severe hepatic disorders 12. Patients with history/signs/symptoms suggestive of an abnormality of calcium homeo-stasis associated with clinically significant hypercalcaemia 13. Patients with history of cancer except for basal cell carcinoma 14. Current participation in any other interventional clinical trial 15. Patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation 16. Previously randomised in this study 17. 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 |
|---|---|
| Main Objective: To compare the clinical efficacy of LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with hand eczema after once daily treatment for three weeks.;Secondary Objective: To compare the safety LEO19123 cream (calcipotriol 50 mcg/g and LEO80122 0.6 mg/g), LEO19123 cream (calcipotriol 15 mcg/g and LEO80122 0.2 mg/g), and LEO19123 cream vehicle alone, in patients with hand eczema after once daily treatment for three weeks.;Primary end point(s): Investigator’s global assessment at end of treatment. | — |
Countries
United Kingdom
Outcome results
None listed