Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: Calcipotriol plus hydrocortisone (LEO 80190); LEO 80190 Vehicle; Hydrocortisone; Calcipotriol
Intervention description: Once daily application
Intervention MeSH terms: Calcitriol; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Calcipotriene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      There are few therapies suitable for the treatment of psoriasis on the face and skin folds.
      As these areas are sensitive, irritation and other adverse reactions are more common than
      elsewhere on the body. The purpose of the study is to compare the efficacy and safety of once
      daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus
      hydrocortisone 10 mg/g with calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10
      mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis
      vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the
      safety and efficacy will be evaluated for up to 60 weeks treatment as required of
      calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face
      and intertriginous areas (= open-label phase).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of psoriasis vulgaris involving the face

          -  Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier
             diagnosed 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 all
             facial lesions)

          -  Treatment areas (the face and the intertriginous areas) amenable to topical treatment
             with a maximum of 100 g of ointment per week

          -  Disease severity graded as mild, moderate, severe or very severe according to the
             investigator's global assessment of disease severity of the face

        Exclusion Criteria:

          -  Systemic treatments with all other therapies than biologicals, with a potential effect
             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 or
             with 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 period
             prior 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-week
             period prior to randomisation

          -  Initiation of or expected changes in concomitant medication that may affect psoriasis
             vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) 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 skin infections,
             parasitic infections, skin manifestations in relation to syphilis or tuberculosis,
             rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae,
             fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds

          -  Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitis and
             cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on the face
             or on the intertriginous areas

          -  Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the
             study

          -  Known or suspected severe renal insufficiency or severe hepatic disorders

          -  Known or suspected disorders of calcium metabolism associated with hypercalcaemia