Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel Compared With Tacalcitol Ointment and the Gel Vehicle Alone in Patients With Psoriasis Vulgaris

Inclusion criteria

• Signed and dated informed consent to be obtained prior to any trial related procedure, including wash-out
• Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of LEO 80185 gel per week or 10 g per day of tacalcitol ointment
• Disease severity graded moderate, severe or very severe according to the Investigator's global assessment (IGA) of disease severity
• A minimum PASI score for extent of 2 in at least one body region (i.e.psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
• Subjects aged 18 years or above
• Either sex
• Any ethnic origin
• Attending hospital outpatient clinic or the private practice of a dermatologist

Exclusion criteria

• Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
• Systemic treatment with all other therapies than biologics, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 4 weeks prior to randomisation
• Systemic treatment with Vitamin D preparations above 500 IU per day
• PUVA or Grenz ray therapy within 4 weeks prior to randomization
• UVB therapy within 2 weeks prior to randomisation
• Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation
• Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with potent or very potent (WHO group III-IV) corticosteroids or vitamin D analogues within 2 weeks prior to randomisation
• Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with very potent (WHO group IV) corticosteroids or vitamin D analogues within 2 weeks prior to randomisation
• Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, ACE inhibitors, anti-malaria drugs, lithium) during the study
• Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
• Subjects with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atro-phicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
• Known or suspected disorders of calcium metabolism associated with hypercalcaemia
• Known or suspected severe renal insufficiency or severe hepatic disorders
• Known or suspected hypersensitivity to component(s) of the Investigational Products
• Current participation in any other interventional clinical study
• Subjects 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 the 4-week period prior to randomisation, except for biologics (3 months)
• Planned exposure to sun during the study that may affect psoriasis vulgaris
• Previously randomised to this study
• Subjects known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychotic state)
• Females of child-bearing potential wishing to become pregnant during the study, or are breast-feeding, or not using an adequate method of contraception during the study
• Females of child-bearing potential with positive pregnancy test at Visit 1