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

Launched by LEO PHARMA · May 6, 2014

Keywords

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Gender

ALL

Eligibility criteria

• 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