Efficacy and Safety of Calcipotriol Plus Betamethasone Gel in the Treatment of Scalp Psoriasis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether once daily treatment for up to 8 weeks of calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel is safe and more effective than betamethasone 0.5 mg/g (as dipropionate) in the gel vehicle, calcipotriol 50 mcg/g in the gel vehicle or the gel vehicle used alone in patients with scalp psoriasis. The primary outcome is the proportion of patients with absence of disease or very mild disease after 8 weeks of treatment.

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 Scalp Psoriasis

Conditions
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Psoriasis of Scalp

Intervention / Treatment
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* Drug: Calcipotriol plus betamethasone dipropionate (LEO80185 gel)


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Scalp psoriasis amenable to topical treatment Psoriasis vulgaris on trunk and/or limbs Extent of scalp psoriasis involving more than 10% of the total scalp area Disease severity on the scalp graded as mild or worse by the investigator Consenting out-patients of 18 years or above Main Exclusion Criteria: PUVA or Grenz ray therapy within 4 weeks prior to randomisation UVB therapy within 2 weeks prior to randomisation Systematic treatment with biological therapies, with a possible effect on scalp psoriasis within 6 months prior to randomisation Systemic treatment with all other therapies than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation Topical treatment of the face, trunk and/or limbs with very potent WHO group IV corticosteroids within 2 weeks prior to randomisation Current diagnosis of 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 (LEO80185 gel)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall disease severity according to investigator's assessment at week 8 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sign score at week 8 |  |  | 
| Score for scaliness, redness and thickness at week 8 |  |  | 
| Extent of scalp psoriasis at week 8 |  |  | 
| Overall disease severity according to investigator's assessment at week 2 and 4 |  |  | 
| Overall disease severity according to patients at week 8 |  |  | 
| Adverse events |  |  | 
| Laboratory data |  |  |