Patient insights following use of LEO 90100 aerosol foam and Daivobet® gel in subjects with psoriasis vulgaris
- Conditions
- Psoriasis vulgarisMedDRA version: 17.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-003072-24-DE
- Lead Sponsor
- EO Pharma A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 219
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br> - Within subject difference in response to TPUQ between previous treatment(s) and each of the two trial treatments <br> - Responses to CLTT for each of the two trial treatments<br> - Overall treatment preference (SPA, week 2) and association with baseline characteristics<br> - Reasons for overall preference assessed by SPA at week 2;Timepoint(s) of evaluation of this end point: Week 2
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable