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.

View Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

303

Study ID:

NCT01536938

Recruitment Status:

Completed

Sponsor:

LEO Pharma

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There are 31 Locations for this study

See Locations Near You

Burke Pharmaceutical Research
Hot Springs Arkansas, 71913, United States
Dermatology Research Associates
Los Angeles California, 90045, United States
Dermatology Specialists, Inc.
Oceanside California, 92056, United States
Skin Surgery Medical Group, Inc
San Diego California, 92117, United States
University Clinical Trials, Inc.
San Diego California, 92123, United States
Clinical Science Institute
Santa Monica California, 90404, United States
Colorado Medical Research Center, Inc
Denver Colorado, 80210, United States
Horizons Clinical Research Center
Denver Colorado, 80220, United States
Dermatology Associates and Research
Coral Gables Florida, 33134, United States
North Florida Dermatology Associates, PA
Jacksonville Florida, 32204, United States
International Dermatology Research, Inc.
Miami Florida, 33144, United States
Altman Dermatology Associates
Arlington Heights Illinois, 60005, United States
Glazer Dermatology
Buffalo Grove Illinois, 60089, United States
Clinical Research Advantage, Inc./Hudson Dermatology, LLC
Evansville Indiana, 47714, United States
Dawes Fretzin Clinical Research Group
Indianapolis Indiana, 46256, United States
The Indiana Clinical Trials Center
Plainfield Indiana, 46168, United States
Owensboro Dermatology Associates
Owensboro Kentucky, 42303, United States
David Fivenson, MD, PLC
Ann Arbor Michigan, 48103, United States
Great Lakes Research Group, Inc.
Bay City Michigan, 48706, United States
Derm Center
Troy Michigan, 48084, United States
Grekin Skin Institute
Warren Michigan, 48008, United States
Minnesota Clinical Study Center
Fridley Minnesota, 55432, United States
Psoriasis Treatment Center of Central NJ
East Windsor New Jersey, 08520, United States
The Dermatology Group, PC
Verona New Jersey, 07044, United States
Derm Research Center of New York
Stony Brook New York, 11790, United States
Philadelphia Institute of Dermatology
Fort Washington Pennsylvania, 19034, United States
Menter Dermatology Research Institute
Dallas Texas, 75246, United States
Center for Clinical Studies
Houston Texas, 77065, United States
Clinical Trials of Texas, Inc
San Antonio Texas, 78229, United States
Dermatology Clinical Research Center of San Antonio
San Antonio Texas, 78229, United States
Progressive Clinical Research
San Antonio Texas, 78229, United States
Virginia Clinical Research, Inc.
Norfolk Virginia, 23507, United States
Premier Clinical Research
Spokane Washington, 99204, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

303

Study ID:

NCT01536938

Recruitment Status:

Completed

Sponsor:


LEO Pharma

How clear is this clinincal trial information?

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