Clinical trial NCT00670241 (phase 3, status: completed)
Conditions: psoriasis vulgaris
ICD codes: L40.0
Drugs: calcipotriol and betamethasone (leo 80185 gel), leo 80185 vehicle, tacalcitol ointment
SMILES: [H][C@@]12C[C@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, CC1=CC(O)=CC(C)=C1Cl, CC(C)[C@H](O)CC[C@@H](C)[C@H]1CC[C@H]2\C(CCC[C@]12C)=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Eligibility criteria:

        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