Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel in Psoriasis Vulgaris

Study Overview
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Brief Summary
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The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks. The primary response criterion is the number of patients with controlled disease at week 8.

Official Title
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Calcipotriol Plus Betamethasone Dipropionate Gel Compared to Betamethasone Dipropionate in the Gel Vehicle, Calcipotriol in the Gel Vehicle and the Gel Vehicle Alone in Psoriasis Vulgaris

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week An investigators' global assessment of disease severity of at least mild Exclusion Criteria: PUVA or Grenz ray therapy within 4 weeks prior to randomisation UVB therapy within 2 weeks prior to randomisation Systemic treatment with biological therapies, with a possible effect on psoriasis vulgaris within 6 months prior to randomisation Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation Topical treatment for other relevant skin disorders (except WHO group I-II corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Calcipotriol plus betamethasone dipropionate (LEO 80185) gel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with controlled disease (minimal or clear and at least two steps change from baseline) according to the investigators' global assessment of disease severity at week 4 and week 8. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8. |  |  | 
| Patients with controlled disease according to the investigators' global assessment of disease severity at week 1, 2, and 6. |  |  | 
| Patients with clear or very mild disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8. |  |  |