LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

Study Overview
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Brief Summary
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The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

Official Title
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LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: LEO 90100 aerosol foam
* Drug: Aerosol foam vehicle
* Drug: Calcipotriol BDP gel
* Drug: Gel vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or above Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA) A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs. Exclusion Criteria: Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation: etanercept - within 4 weeks prior to randomisation adalimumab, infliximab - within 8 weeks prior to randomisation ustekinumab - within 16 weeks prior to randomisation other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer) Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to randomisation) Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEO 90100<br>LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks | Drug: LEO 90100 aerosol foam<br> <br> |
| Placebo Comparator: Aerosol foam vehicle<br>Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks | Drug: Aerosol foam vehicle<br> <br> |
| Active Comparator: Calcipotriol BDP gel<br>Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks | Drug: Calcipotriol BDP gel<br> <br> |
| Placebo Comparator: Gel vehicle<br>Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks | Drug: Gel vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success According to the PGA | To compare the efficacy of treatment of LEO 90100 at Week 4 to that of calcipotriol BDP gel at Week 8 in subjects with psoriasis vulgaris. Five-point assessment (clear, almost clear, mild, moderate, and severe) was made for the severity of psoriasis vulgaris on the trunk and limbs at all on-treatment visits using Physician's Global Assessment of Disease Severity (PGA). 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline. | 4 Weeks for LEO 90100 and 8 weeks for calcipotriol BDP gel | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With PASI 75 at Week 4 for LEO 90100 and at Week 8 for Calcipotriol BDP Gel. | Subjects with PASI 75 (a 75% reduction in the modified Psoriasis Area and Severity Index) at Week 4 for LEO 90100 and at Week 8 for calcipotriol BDP gel. | Week 4 for LEO 90100; Week 8 for calcipotriol BDP gel | 
| Time to 'Treatment Success' According to PGA. | Time to treatment success was calculated as the number of weeks from baseline to the visit where the subject first achieved treatment success. 'Treatment success' was defined as achieving 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline and 'clear' for subjects with 'mild' disease at baseline. | From Baseline to Week 12 | 
| Change in Itch as Assessed on a VAS Scale (LEO 90100 vs. the Foam Vehicle Group). | Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale (VAS) - range from 0 (no itch at all) to 100 mm (worst itch one could imagine). | Baseline to Week 4 | 
| Change in Itch as Assessed on a VAS Scale From Baseline to Week 4 (LEO 90100) vs. Week 8 (Calcipotriol BDP Gel). | Maximum itch during the previous 24 hours was assessed on a Visual Analogue Scale - range from 0 (no itch at all) to 100 mm (worst itch one could imagine). | Baseline to Week 4; Baseline to Week 8 |