Psoriasis of Scalp
Conditions
Brief summary
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.
Interventions
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall disease severity according to investigator's assessment at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Total sign score at week 8 | — |
| Adverse events | — |
| Laboratory data | — |
| Overall disease severity according to patients at week 8 | — |
Countries
Canada, Denmark, France, Norway, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed