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
Fridley, Minnesota 55432
629
mi
from 43215
Fridley, MN
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
1159
mi
from 43215
Denver, CO
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1137
mi
from 43215
San Antonio, TX
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
1137
mi
from 43215
San Antonio, TX
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
1137
mi
from 43215
San Antonio, TX
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Ann Arbor, Michigan 48103
164
mi
from 43215
Ann Arbor, MI
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Arlington Heights, Illinois 60005
299
mi
from 43215
Arlington Heights, IL
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Bay City, Michigan 48706
255
mi
from 43215
Bay City, MI
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Buffalo Grove, Illinois 60089
298
mi
from 43215
Buffalo Grove, IL
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Coral Gables, Florida 33134
995
mi
from 43215
Coral Gables, FL
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911
mi
from 43215
Dallas, TX
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Denver, Colorado 80210
1161
mi
from 43215
Denver, CO
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East Windsor, New Jersey 08520
448
mi
from 43215
East Windsor, NJ
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278
mi
from 43215
Evansville, IN
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Fort Washington, Pennsylvania 19034
413
mi
from 43215
Fort Washington, PA
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Hot Springs, Arkansas 71913
670
mi
from 43215
Hot Springs, AR
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Houston, Texas 77030
995
mi
from 43215
Houston, TX
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Indianapolis, Indiana 46256
158
mi
from 43215
Indianapolis, IN
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Jacksonville, Florida 32204
670
mi
from 43215
Jacksonville, FL
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Los Angeles, California 90045
1982
mi
from 43215
Los Angeles, CA
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993
mi
from 43215
Miami, FL
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Norfolk, Virginia 23507
422
mi
from 43215
Norfolk, VA
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Oceanside, California 92056
1945
mi
from 43215
Oceanside, CA
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Owensboro, Kentucky 42303
267
mi
from 43215
Owensboro, KY
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Plainfield, Indiana 46168
179
mi
from 43215
Plainfield, IN
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San Diego, California 92117
1950
mi
from 43215
San Diego, CA
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San Diego, California 92123
1951
mi
from 43215
San Diego, CA
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Santa Monica, California 90404
1984
mi
from 43215
Santa Monica, CA
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Spokane, Washington 99204
1779
mi
from 43215
Spokane, WA
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Stony Brook, New York 11790
524
mi
from 43215
Stony Brook, NY
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Troy, Michigan 48084
179
mi
from 43215
Troy, MI
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Verona, New Jersey 07044
465
mi
from 43215
Verona, NJ
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Warren, Michigan 48093
175
mi
from 43215
Warren, MI
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