A Psoriasis Plaque Test Trial With LEO 90100 Compared to Betesil® in Patients With Psoriasis Vulgaris

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

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