Official Title: “Calcipotriol Plus Hydrocortisone in Paediatric Patients (Aged 6 to 17 Years) With Psoriasis Vulgaris on the Face and on the Intertriginous Areas”

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

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: March 2011

Intervention(s) in this Clinical Trial

• Drug: LEO 80190
  • Applied once daily
• Drug: Hydrocortisone
  • Applied once daily

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: LEO 80190 ointment
• Active Comparator: Hydrocortisone 10 mg/g ointment

Primary Measures

• The percentage change in PASI of the face from baseline to week 8
  • Time Frame: Week 8
    Safety Issue?: No

Secondary Measures

• Patients with "controlled disease" according to the investigator's global assessment of disease severity on the face
  • Time Frame: Week 8
    Safety Issue?: No
• The percentage change in PASI of the face from baseline to Week 4
  • Time Frame: Week 4
    Safety Issue?: No
• Patients with "controlled disease" according to the investigator's global assessment of disease severity of the intertriginous areas
  • Time Frame: Week 8
    Safety Issue?: No
• The percentage change in Total Sign Score of the intertriginous areas from baseline to week 8
  • Time Frame: Week 8
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: LEO Pharma

Overall Clinical Trial Officials and Contacts

Frédéric Cambazard, MD Principal Investigator FRANCE  

Overall Contact: Richard Bennett, BSc +44 1844 276264 richard.bennett@leo-pharma.com

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01007591

Study ID Number: LEO 80190-O25

ClinicalTrials.gov Identifier: NCT01007591

Health Authority: Canada: Health Canada