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 plus betamethasone dipropionate gel is more effective than twice daily treatment of calcipotriol scalp solution in patients with scalp psoriasis. The primary outcome is patients with clear or minimal disease after 8 weeks treatment. Further the occurrence of relapse and rebound after end of treatment in patients with clear or minimal disease will be investigated.
Interventions
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
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 moderate 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 * 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 non steroid 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 |
|---|---|
| Total sign score at week 8 | — |
| Score for redness, thickness and scaliness at week 8 | — |
| Overall disease severity according to the investigator's assessment at week 2 and 4 | — |
| Overall disease severity according to patients at week 8 | — |
| Relapse and rebound during the study | — |
Countries
Belgium, Canada, Denmark, France, Sweden
Outcome results
None listed