Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

Inclusion Criteria:

• Clinical diagnosis of psoriasis vulgaris involving the face

• Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlierdiagnosed with psoriasis vulgaris on the trunk and/or the limbs

• An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of allfacial lesions)

• Treatment areas (the face and the intertriginous areas) amenable to topicaltreatment with a maximum of 100 g of ointment per week

• Disease severity graded as mild, moderate, severe or very severe according to theinvestigator's global assessment of disease severity of the face

Exclusion Criteria:

• Systemic treatments with all other therapies than biologicals, with a potentialeffect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids,immunosuppressants) within the 4-week period prior to randomisation

• Systemic use of biological treatments, whether marketed or not, directed against orwith a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab,etanercept, infliximab, adalimumab) within 3 months 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 the face and the intertriginous areas within the 2-week periodprior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the double-blind phase of the study)

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

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

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

• Patients 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, ichthyosis, acne rosacea, ulcers and wounds

• Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitisand cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on theface or on the intertriginous areas

• Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris duringthe study

• Known or suspected severe renal insufficiency or severe hepatic disorders

• Known or suspected disorders of calcium metabolism associated with hypercalcaemia