Psoriasis Clinical Trial
LEO 90100 in the Treatment of Psoriasis Vulgaris
Summary
The purpose of this study is to investigate whether LEO 90100, calcipotriol and betamethasone are effective in the treatment of psoriasis vulgaris.
Eligibility Criteria
Inclusion Criteria:
Signed and dated informed consent obtained prior to any trial related activities (including washout period).
Age 18 years or above
Either sex
Any race or ethnicity
All skin types
Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).
Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year).
Able to communicate with the investigator and understand and comply with the requirements of the study.
Exclusion Criteria:
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, alefacept, infliximab - within 8 weeks prior to randomisation
ustekinumab - within 16 weeks prior to randomisation
other products - 4 weeks/5 half-lives (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 nonmarketed 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.
PUVA therapy within 4 weeks prior to randomisation.
UVB therapy within 2 weeks prior to randomisation.
Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the study.
Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors) during the study.
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds.
Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris.
Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
Known or suspected severe renal insufficiency or severe hepatic disorders.
Known or suspected hypersensitivity to component(s) of the investigational products.
Current participation in any other interventional clinical study.
Previously randomised in this study.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
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There are 31 Locations for this study
Hot Springs Arkansas, 71913, United States
Los Angeles California, 90045, United States
Oceanside California, 92056, United States
San Diego California, 92117, United States
San Diego California, 92123, United States
Santa Monica California, 90404, United States
Denver Colorado, 80210, United States
Denver Colorado, 80220, United States
Coral Gables Florida, 33134, United States
Jacksonville Florida, 32204, United States
Miami Florida, 33144, United States
Arlington Heights Illinois, 60005, United States
Buffalo Grove Illinois, 60089, United States
Evansville Indiana, 47714, United States
Indianapolis Indiana, 46256, United States
Plainfield Indiana, 46168, United States
Owensboro Kentucky, 42303, United States
Ann Arbor Michigan, 48103, United States
Bay City Michigan, 48706, United States
Troy Michigan, 48084, United States
Warren Michigan, 48008, United States
Fridley Minnesota, 55432, United States
East Windsor New Jersey, 08520, United States
Verona New Jersey, 07044, United States
Stony Brook New York, 11790, United States
Fort Washington Pennsylvania, 19034, United States
Dallas Texas, 75246, United States
Houston Texas, 77065, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Norfolk Virginia, 23507, United States
Spokane Washington, 99204, United States
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