Clinical trial NCT02310646: Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2014-12-08
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Overall Treatment Preference by Subject's Preference Assessment (SPA) at Week 2 and Association With Baseline Characteristics
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
measure: Within Subject Difference in Response to Topical Product Usability Questionnaire (TPUQ) Items Between Trial Treatments
timeFrame: 2 weeks
measure: Within Subject Difference in Response to TPUQ Between the Last Topical Anti-psoriatic Treatment and Each of the 2 Trial Treatments
timeFrame: Baseline to Week 2
measure: Responses to Comparison to Last Topical Treatment Questionnaire (CLTT) for Each of the Two Trial Treatments (Foam or Gel)
timeFrame: At Week 1 and Week 2
measure: Within Subject Difference in Response to Vehicle Preference Measure (VPM) Items Between Trial Treatments
timeFrame: At Week 1 and Week 2
measure: Reasons for Overall Preference as Assessed by Subject's Preference Assessment (SPA) at Week 2
timeFrame: Baseline to Week 2
Locations:
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc.
state: Ontario
Study officials:
affiliation: K. Papp Clinical Research INC.
name: Kim Papp, MD phD
role: PRINCIPAL_INVESTIGATOR
References: