Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris

Study Overview
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Brief Summary
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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.

Detailed Description
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An international, multi-centre, prospective, open-label, randomised, 2-arm, cross-over study with 14-days once daily treatment in subjects with psoriasis vulgaris. 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.

Official Title
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A Clinical Trial Gathering Insight of Patient Reported Factors That Influence Preference Following Once Daily Topical Treatment With LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris

Conditions
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Psoriasis Vulgaris

Intervention / Treatment
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* Drug: LEO 90100 Aerosol Foam
* Drug: Daivobet® gel


Participation Criteria
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Eligibility Criteria
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Inclusion: 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) Exclusion: Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisation. Any previous topical treatment with calcipotriol plus betamethasone gel (Daivobet® gel or Xamiol® gel). Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation. Ultraviolet B (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 participation in any other interventional clinical trial. Previously randomised into this trial. 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 infections, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group 1<br>Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel | Drug: LEO 90100 Aerosol Foam<br>* Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week<br>Drug: Daivobet® gel<br>* Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week.<br>|
| Active Comparator: Treatment group 2<br>Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam | Drug: LEO 90100 Aerosol Foam<br>* Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week<br>Drug: Daivobet® gel<br>* Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics | The SPA questionnaire was completed at Week 2 and consisted of 2 parts: (i) the subject indicated if they preferred LEO 90100 foam or Daivobet® gel based on their experience using these products for 1 week each during the 2-weeks treatment period; (ii) the subject indicated how much each of the 22 items under the application, formulation, and container domains contributed to their overall decision of which product they preferred. This part of the SPA tool used a 4-point scale ranging from 'very important factor' to 'not at all important factor'. The statistical significance of each of the following 7 baseline characteristics (gender, age, disease severity, distribution, plaque size, skin thickness, onset) was tested in a 2-factor logistic regression model with treatment sequence and each baseline characteristic as factors. Results of multiple regression analyses are provided in the Clinical Study Report which can be found on the LEO Pharma website. | 2 weeks |