Patient insights following use of LEO 90100 aerosol foam and Daivobet® gel in subjects with psoriasis vulgaris

INTERVENTION: Product Code: LEO 90100 Pharmaceutical Form: Cutaneous foam INN or Proposed INN: CALCIPOTRIOL HYDRATE CAS Number: 147657‐22‐5 Other descriptive name: CALCIPOTRIOL MONOHYDRATE Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 0.05‐ INN or Proposed INN: BETAMETHASONE DIPROPIONATE CAS Number: 5593‐20‐4 Other descriptive name: BETAMETHASONE DIPROPIONATE Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 0.643‐ Trade Name: Daivobet/Dovobet gel Product Name: Daivobet/Dovovet gel Pharmaceutical Form: Gel INN or Proposed INN: CALCIPOTRIOL MONOHYDRATE CAS Number: 147657‐22‐5 Other descriptive name: CALCIPOTRIOL MONOHYDRATE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 0.05‐ INN or Proposed INN: BETAMETHASONE DIPROPIONATE CAS Number: 5593‐20‐4 Other descriptive name: BETAMETHASONE DIPROPIONATE Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 0.643‐ CONDITION: Psoriasis vulgaris ; MedDRA version: 17.1 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858 Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: 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. 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 Secondary Objective: Not Applicable Timepoint(s) of evaluation of this end point: Week 2 SECONDARY OUTCOME: Secondary end point(s): Not Applicable Timepoint(s) of evaluation of this end point: Not Applicable 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