a psoriasis plaque test trial with leo 90100 compared to betesil® in patients with psoriasis vulgaris

Conditions: Skin and Connective Tissue Diseases

Summary: the purpose of this study is to evaluate the anti-psoriatic effect of leo 90100 aerosol foam compared with betesil® medicated plaster

the products will be applied on 6 test sites (each product on 3 test sites) once daily 6 days a week (except sundays) for 4 weeks. the application sites for each product will be determined according to random assignment. depending on the size of the psoriasis plaques, 2 or 4 test sites will be located within the same plaque; the treatment assignment will be done pair-wise.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent has been obtained * subjects with a diagnosis of psoriasis vulgaris with preferably three lesions (plaques) located on arms, legs and/or trunk or at least two lesions (plaques) located on arms, legs and/or trunk. for subjects with three lesions, each lesion must have a size suitable to accommodate 2 test sites (test site area 5 cm2, distance between two test sites at least 2 cm). for subjects with two lesions, one lesion must have a size suitable to accommodate 4 test sites, and the other lesion must accommodate 2 test sites. * age 18 years or above * outpatients * female subjects must be of either * non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or, * child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy. exclusion criteria: * female subjects who are breast feeding * 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 and during the trial * adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial * ustekinumab - within 16 weeks prior to randomisation and during the trial * other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer) * systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial * subjects using phototherapy within the following time periods prior to randomisation and during the trial: * puva: 4 weeks * uvb: 2 weeks * subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial: * potent or very potent (who group iii-iv) corticosteroids * subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial: * who group i-ii corticosteroids (except if used for treatment of scalp and/or facial psoriasis) * topical retinoids, vitamin d analogues, topical immunomodulators (e.g. calcineurin inhibitors), tar products, salicylic acid * subjects using emollients on the selected plaques within 1 week before randomisation and during the trial * initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ace inhibitors) within 2 weeks prior to the randomisation and during the trial * subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Keywords: psoriasis