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

LEO Pharma1,485 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,485

Conditions

Psoriasis of Scalp

Interventions

Calcipotriol plus betamethasone dipropionate (LEO80185 gel)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

FRCPC, Centre de Recherche Dermatologique du Quebec Metropolitain

Québec, Canada

Roskilde Hospital, Division of Dermatology

Roskilde, Denmark

Hôpital de l'Archet, Service de Dermatologie

Nice, France

Hudlegekontoret

Sandvika, Norway

Outcomes

Primary Outcomes

Overall disease severity according to investigator's assessment at week 8

Secondary Outcomes

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

Data from ClinicalTrials.gov

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