LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

LEO 90100 Aerosol Foam Compared to Calcipotriol Plus Betamethasone Dipropionate Gel in Subjects With Psoriasis Vulgaris

The purpose is to compare the efficacy of treatment with LEO 90100 at Week 4 to that of calcipotriol plus betamethasone dipropionate (BDP) gel at Week 8 in subjects with psoriasis vulgaris

Inclusion Criteria:

• Age 18 years or above
• 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)
• A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and limbs
• A modified Psoriasis Area Severity Index (PASI) score of at least 2 on the trunk and limbs.

Exclusion Criteria:

• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

• Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

  • etanercept - within 4 weeks prior to randomisation
  • adalimumab, infliximab - within 8 weeks prior to randomisation
  • ustekinumab - within 16 weeks prior to randomisation
  • other products - within 4 weeks/5 half-lives prior to randomisation (whichever is longer)

• Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants within 4 weeks prior to randomisation)

• 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.

• Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation

• Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation

• Topical anti-psoriatic treatment on the trunk and limbs (except for emollients) within 2 weeks prior to randomisation

• Topical treatment on the face, scalp and skin folds with corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation

• Females who are pregnant, wishing to become pregnant during the trial or are breastfeeding