Psoriasis vulgaris MedDRA version: 17.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Sponsors
LEO Pharma A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 18 years or above - At Day 1 (Visit 1), a clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs amenable to treatment with a maximum of 60 g of study medication per week - Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA) at Day 1 (Visit 1) - A Physician’s Global Assessment of disease severity (PGA) of at least mild on trunk and/or limbs at Day 1 (Visit 1) - A modified PASI (m-PASI) score of at least 2 on the trunk and/or limbs at Day 1 (Visit 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisa-tion. - Any previous topical treatment with Daivobet® gel. - PUVA therapy within 4 weeks prior to randomisation. - UVB therapy within 2 weeks prior to randomisation. - Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps etc.) during the trial. - Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation. - Previously randomised into a clinical trial involving LEO 90100. - Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis. - Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infec-tions, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ulcers and wounds. - Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis. - Known or suspected disorders of calcium metabolism associated with hypercalcaemia. - Known or suspected severe renal insufficiency or severe hepatic disorders. - Known or suspected hypersensitivity to component(s) of the investigational products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.;Secondary Objective: Not Applicable;Primary end point(s): - Within subject difference in response to TPUQ and VPM items between trial treatments - Within subject difference in response to TPUQ between previous treatment(s) and each of the two trial treatments - Responses to CLTT for each of the two trial treatments - Overall treatment preference (SPA, week 2) and association with baseline characteristics - Reasons for overall preference assessed by SPA at week 2;Timepoint(s) of evaluation of this end point: Week 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Canada, Germany
Contacts
Public ContactRichard Bennett
LEO Pharma A/S
Outcome results
None listed