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

Study Overview
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Brief Summary
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The purpose of the study is to evaluate whether once daily topical 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 and calcipotriol 50 mcg/g in the gel vehicle in patients with scalp psoriasis. The primary response criterion is the number of patients with absence of disease and 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 and Calcipotriol in the Gel Vehicle 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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Inclusion Criteria: Scalp psoriasis amenable to topical treatment with a maximum of 100 g of medication per week Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs Extent of scalp psoriasis involving more than 10% of the total scalp area Investigator's assessment of clinical signs of the scalp of at least 2 in one of the clinical signs, erythema, thickness and scaliness, and at least 1 in each of the other two clinical signs Disease severity on the scalp graded as Mild, Moderate, Severe or Very severe according to the investigator's global assessment of disease severity 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 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 |
| --- | --- | --- |
| - Patients with Controlled disease (Absence of disease or Very mild disease) according to investigator's global assessment of disease severity 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 |  |  | 
| - Patients with Controlled disease (Absence of disease or Very mild disease) according to investigator's global assessment of disease severity at week 2 and 4 |  |  | 
| - Patients with Treatment success (Almost clear or Cleared) according to patient's overall assessment of disease severity at week 8 |  |  | 
| - Evaluation of Adverse Events |  |  | 
| - Evaluation of Laboratory Data |  |  |