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
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 80190; Hydrocortisone
Intervention description: Applied once daily; Applied once daily
Intervention MeSH terms: Hydrocortisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      An international, multi-centre, prospective, randomised, double-blind, active-controlled,
      2-arm, parallel group, 8-week, phase 3 clinical study in paediatric patients (aged 6 to 17
      years) with psoriasis vulgaris on the face and on the intertriginous areas
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of psoriasis vulgaris involving the face

          -  Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier
             diagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity
             of psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapy with
             any of the allowed medications

          -  An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all
             facial lesions)

          -  Treatment areas (the face and the intertriginous areas) amenable to topical treatment
             with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week

          -  Disease severity graded as mild, moderate or severe according to the investigator's
             global 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 on
             psoriasis vulgaris within the 4-week period prior to randomisation

          -  Systemic treatment with biological therapies (marketed or not marketed) with a
             possible 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 intertriginous
             areas within the 2-week period prior to randomisation

          -  Topical treatment with very potent WHO group IV corticosteroids within the 2-week
             period prior to randomisation

          -  Initiation of or expected changes to concomitant medication that may affect psoriasis
             vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during
             the treatment phase of the study

          -  Current diagnosis of erythrodermic, exfoliative or pustular psoriasis