A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris

Launched by LEO PHARMA · Apr 18, 2012

Keywords

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
• • 2. Age 18 years or above.
• • 3. Males, or females of non-child bearing potential.
• • 4. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).
• Exclusion Criteria:
• • 1. Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
• • 2. Female subjects who are pregnant, of child-bearing potential or who are breast feeding.
• • 3. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months(adalimumab, alefacept, infliximab), 4 months(ustekinumab) or 4 weeks/5 half-lives (which-ever islonger) for experimental biological products prior to randomisation and during the study.
• • 4. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study.
• 5. Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
• • - Potent or very potent (WHO group III-IV) corticosteroids.
• 6. Subjects using of phototherapy within the following time periods prior to randomisation and during the study:
• • PUVA (4 weeks)
• • UVB (2 weeks)
• 7. Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
• • 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. macrolides)
• • Anthracen derivatives
• • Tar,
• • Salicylic acid.
• • 8. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
• • 9. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
• • 10. Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
• • 11. Subjects with current participation in any other interventional clinical, based on interview of the subject