Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: LEO 90100 Aerosol Foam; Daivobet® gel
Intervention description: 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; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion:

          1. 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

          2. 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)

          3. A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk
             and/or limbs at Day 1 (Visit 1)

          4. A modified PASI (m-PASI) score of at least 2 on the trunk and/or limbs at Day 1 (Visit
             1)

        Exclusion:

          1. Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to
             randomisation.

          2. Any previous topical treatment with calcipotriol plus betamethasone gel (Daivobet® gel
             or Xamiol® gel).

          3. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to
             randomisation.

          4. Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation.

          5. 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.

          6. 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.

          7. Previously randomised into a clinical trial involving LEO 90100.

          8. Current participation in any other interventional clinical trial.

          9. Previously randomised into this trial.

         10. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.

         11. 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.

         12. Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis)
             on the treatment area that may confound the evaluation of psoriasis.

         13. Known or suspected disorders of calcium metabolism associated with hypercalcaemia.

         14. Known or suspected severe renal insufficiency or severe hepatic disorders.