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 relatedprocedure, including wash-out

• Clinical diagnosis of psoriasis vulgaris involving trunk and/or arms and/or legsamenable to treatment with a maximum of 100 g of LEO 80185 gel per week or 10 g perday of tacalcitol ointment

• Disease severity graded moderate, severe or very severe according to theInvestigator's global assessment (IGA) of disease severity

• A minimum PASI score for extent of 2 in at least one body region (i.e.psoriasisaffecting 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 apossible 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 effecton 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 weeksprior 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. scalppsoriasis) with very potent (WHO group IV) corticosteroids or vitamin D analogueswithin 2 weeks prior to randomisation

• Planned initiation of, or changes to concomitant medication that could affectpsoriasis 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, parasiticinfections, skin manifestations in relation to syphilis or tuberculosis, rosacea,perioral dermatitis, acne vulgaris, atrophic skin, striae atro-phicae, fragility ofskin 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. anagent 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, orare breast-feeding, or not using an adequate method of contraception during thestudy

• Females of child-bearing potential with positive pregnancy test at Visit 1