LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

Inclusion Criteria:

• Signed and dated informed consent obtained prior to any trial related activities (including any washout period).

• Aged 18 years or above

• Either sex

• Any race or ethnicity

• Attending a hospital outpatient clinic or the private practice of a board certifieddermatologist.

• Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months durationinvolving the non-scalp regions of the body (trunk and/or limbs) amenable totreatment with a maximum of 100 g of topical medication per week.

• An investigator's global assessment of disease severity (IGA) of mild or moderate onthe body (trunk and/or limbs) at Day 0 (Visit 1).

• A minimum modified Psoriasis Area and Severity Index (PASI) score for extent of 2 inat least one body region (i.e. psoriasis affecting at least 10% of arms, and/or 10%of trunk, and/or 10% of legs)

• Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).

• Females of childbearing potential must agree to use a highly effective method ofbirth control during the study. A highly effective method of birth control isdefined as one which results in a low failure rate (less than 1% per year) such asimplants, injectables, combined oral contraceptives, some intrauterine devices,sexual abstinence or vasectomised partner. The patients must have used thecontraceptive method continually for at least 1 month prior to the pregnancy test,and must continue using the contraceptive method for at least 1 week after the lastapplication of study medication. A female is defined as not of child-bearingpotential if she is postmenopausal (12 months with no menses without an alternativemedical cause), or surgically sterile (tubal ligation/section, hysterectomy orbilateral ovariectomy).

• Able to communicate with the investigator and understand and comply with therequirements of the study.

Exclusion Criteria:

• Systemic treatment with biological therapies, whether marketed or not, with apossible effect on psoriasis vulgaris within the following time periods prior torandomisation:

• etanercept - within 4 weeks prior to randomisation

• adalimumab, alefacept, infliximab - within 2 months prior to randomisation

• ustekinumab - within 4 months prior to randomisation

• experimental products - within 4 weeks/5 half-lives (whichever is longer) priorto randomisation

• Systemic treatment with all other therapies with a possible effect on psoriasisvulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and otherimmunosuppressants) within 4 weeks prior to randomisation.

• PUVA or Grenz ray therapy within 4 weeks prior to randomisation.

• UVB therapy within 2 weeks prior to randomisation.

• Any topical treatment of the trunk and/or limbs (except for emollients) within 2weeks prior to randomisation.

• Topical treatment for other relevant skin disorders on the face and flexures (e.g.,facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin Danalogues within 2 weeks prior to randomisation.

• Topical treatment for other relevant skin disorders on the scalp (e.g. scalppsoriasis) with class 1-5 corticosteroids, vitamin D analogues or prescriptionshampoos within 2 weeks prior to randomisation.

• Planned initiation of, or changes to, concomitant medication that could affectpsoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors)during the study.

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

• Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skininfections, parasitic infections, skin manifestations in relation to syphilis ortuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striaeatrophicae, fragility of skin veins, icthyosis, 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 or longer, if the class of substancerequired a longer washout as defined above (e.g. biological treatments).

• Planned excessive exposure to the sun during the study that may affect the psoriasisvulgaris.

• Previously randomised in this study.

• Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or arebreast-feeding. Females of child-bearing potential wishing to become pregnant duringthe study, or not using an adequate method of contraception during the study.