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

Study Overview
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Brief Summary
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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

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

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: LEO 80190
* Drug: Hydrocortisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LEO 80190 ointment<br> | Drug: LEO 80190<br>* Applied once daily<br>|
| Active Comparator: Hydrocortisone 10 mg/g ointment<br> | Drug: Hydrocortisone<br>* Applied once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage Change in Psoriasis Area and Severity Index (PASI) of the Face Last Observation Carried Forward (LOCF) at End of Treatment | PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula: 0.05 (R+T+S) E It ranged from 0 to 3.6. | From baseline (Day 0) to end of treatment (Week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity on the Face LOCF | For subjects with a baseline (Day 0) severity of moderate or worse - controlled disease of the face was defined as clear or almost clear according to the IGA of the face. For subjects with a baseline (Day 0) severity of mild - controlled disease of the face was defined as clear according to the IGA of the face. At baseline (Day 0) to end of treatment (Week 8) the (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below. Clear, almost clear, mild, moderate, severe and very severe. | At end of treatment (Week 8) | 
| The Percentage Change in PASI of the Face LOCF at Week 4 | PASI of the face was to be calculated based on the (sub)investigator's assessment of extent (E), redness (R), thickness (T) and scaliness (S) using the following formula: 0.05 (R+T+S) E It ranged from 0 to 3.6. | From baseline (Day 0) to Week 4 (Day 28) | 
| Participants With Controlled Disease According to the Investigator's Global Assessment (IGA) of Disease Severity of the Intertriginous Areas LOCF | At baseline (Day 0) to end of treatment (Week 8) the (sub)investigator made an assessment of the disease severity of the intertriginous areas using the following 6-category scale. Clear, almost clear, mild, moderate, severe and very severe. For subjects with a baseline (Day 0) severity of moderate or worse - controlled disease of the intertriginous areas was defined as clear or almost clear according to the IGA of the intertriginous areas. For subjects with a baseline (Day 0) severity of mild - controlled disease of the intertriginous areas was defined as clear according to the IGA of the intertriginous areas. | At end of treatment (Week 8) | 
| The Percentage Change in Total Sign Score (TSS) of the Intertriginous Areas LOCF | For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the intertriginous areas was determined according to the scale below: Redness 0.none mild moderate severe very severe Thickness 0.none mild moderate severe very severe Scaliness 0.none mild moderate severe very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS ranging from 0 to 12. | From baseline (Day 0) to end of treatment (Week 8) |