Psoriasis Vulgaris
Conditions
Brief summary
The objective of the study is to compare the use of calcipotriol plus betamethasone dipropionate gel with betamethasone dipropionate in the gel vehicle, calcipotriol in the gel vehicle and the gel vehicle alone when used in patients with psoriasis vulgaris on the trunk and/or limbs. Patients will be treated once daily for up to 8 weeks. The primary response criterion is the number of patients with controlled disease at week 8.
Interventions
DRUGCalcipotriol plus betamethasone dipropionate (LEO 80185) gel
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
* Psoriasis vulgaris involving trunk and/or arms and/or legs amenable to treatment with a maximum of 100 g of topical medication per week * An investigators' global assessment of disease severity of at least mild
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 psoriasis vulgaris within 6 months prior to randomisation * Systemic treatment with all other therapies than biologicals, with a possible effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to randomisation * Any topical treatment of the trunk/limbs (except for emollients) within 2 weeks prior to randomisation * Topical treatment for other relevant skin disorders (except WHO group I-II corticosteroids, tar, retinoid and dithranol on face, scalp, or flexures) within 2 weeks prior to randomisation * Planned initiation of, or changes to concomitant medication that could affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium) during the study * Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with controlled disease (minimal or clear and at least two steps change from baseline) according to the investigators' global assessment of disease severity at week 4 and week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patients with clear or very mild disease by the patient's global assessment of disease severity at week 1, 2, 4, 6, and 8. | — |
| The absolute and percentage change in PASI from baseline to week 1, 2, 4, 6, and 8. | — |
| Patients with controlled disease according to the investigators' global assessment of disease severity at week 1, 2, and 6. | — |
Countries
Canada, Germany, Ireland, Sweden, United Kingdom
Outcome results
None listed