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

LEO Pharma

Status and phase: Completed; Phase 3

Conditions: Psoriasis Vulgaris

Treatments: Drug: LEO 90100 Aerosol Foam; Drug: Daivobet® gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02310646

LP0053-1030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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219 participants in 2 patient groups

Treatment group 1

Active Comparator group

Description:

Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel

Treatment:

Drug: Daivobet® gel

Drug: LEO 90100 Aerosol Foam

Treatment group 2

Active Comparator group

Description:

Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam

Treatment:

Drug: Daivobet® gel

Drug: LEO 90100 Aerosol Foam