A Study Comparing LEO 80190 Ointment With Hydrocortisone Ointment, Both Applied Once Daily in the Treatment of Psoriasis Vulgaris on the Face and Intertriginous Areas

Inclusion Criteria:

• Clinical diagnosis of psoriasis vulgaris involving the face

• Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlierdiagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severityof psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapywith any of the allowed medications

• An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of allfacial lesions)

• Treatment areas (the face and the intertriginous areas) amenable to topicaltreatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) ofointment per week

• Disease severity graded as mild, moderate or severe according to the investigator'sglobal assessment of disease severity of the face

• Aged 6 to 17 years

Exclusion Criteria:

• Systemic treatment with therapies other than biologicals with a potential effect onpsoriasis vulgaris within the 4-week period prior to randomisation

• Systemic treatment with biological therapies (marketed or not marketed) with apossible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation

• PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation

• UVB therapy within the 2-week period prior to randomisation

• Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginousareas within the 2-week period prior to randomisation

• Topical treatment with very potent WHO group IV corticosteroids within the 2-weekperiod prior to randomisation

• Initiation of or expected changes to concomitant medication that may affectpsoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACEinhibitors) during the treatment phase of the study

• Current diagnosis of erythrodermic, exfoliative or pustular psoriasis