LEO 90100 in the Treatment of Psoriasis Vulgaris



Status:Completed
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2012
End Date:November 2012

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The purpose of this study is to investigate whether LEO 90100, calcipotriol and
betamethasone are effective in the treatment of psoriasis vulgaris.


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.
We found this trial at
33
sites
Stony Brook, New York 11790
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Stony Brook, NY
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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Denver, CO
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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San Antonio, TX
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
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San Antonio, TX
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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San Antonio, TX
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Ann Arbor, Michigan 48103
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Ann Arbor, MI
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Arlington Heights, Illinois 60005
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Arlington Heights, IL
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Bay City, Michigan 48706
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Bay City, MI
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Buffalo Grove, Illinois 60089
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Buffalo Grove, IL
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Coral Gables, Florida 33134
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Coral Gables, FL
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Dallas, TX
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Denver, Colorado 80210
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East Windsor, New Jersey 08520
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East Windsor, NJ
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Evansville, IN
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Fort Washington, Pennsylvania 19034
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Fort Washington, PA
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Fridley, Minnesota 55432
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Fridley, MN
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Hot Springs, Arkansas 71913
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Hot Springs, AR
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Houston, Texas 77030
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Houston, TX
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Indianapolis, Indiana 46256
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Indianapolis, IN
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Jacksonville, Florida 32204
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Jacksonville, FL
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Los Angeles, California 90045
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Los Angeles, CA
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Miami, FL
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Norfolk, Virginia 23507
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Norfolk, VA
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Oceanside, California 92056
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Owensboro, Kentucky 42303
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Plainfield, Indiana 46168
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San Diego, California 92117
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San Diego, CA
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San Diego, California 92123
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Santa Monica, California 90404
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Santa Monica, CA
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Spokane, Washington 99204
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Spokane, WA
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Troy, Michigan 48084
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Troy, MI
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Verona, New Jersey 07044
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Verona, NJ
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Warren, Michigan 48093
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Warren, MI
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