Psoriasis of Scalp
Conditions
Brief summary
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.
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
* 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| - 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 | — |
| - Total sign score at week 8 | — |
| - Evaluation of Adverse Events | — |
| - Evaluation of Laboratory Data | — |
| - Patients with Treatment success (Almost clear or Cleared) according to patient's overall assessment of disease severity at week 8 | — |
Countries
Belgium, Canada, Finland, France, Germany, Netherlands, United Kingdom
Outcome results
None listed