LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris
NCT ID: NCT01536886
Last Updated: 2025-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
376 participants
INTERVENTIONAL
2012-05-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LEO 90100 vehicle
Aerosol foam with no active ingredient
LEO 90100 vehicle
Betamethasone plus calcipotriol
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
Betamethasone plus calcipotriol
LEO 90100
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
LEO 90100
Ointment vehicle
Ointment with no active ingredients
Ointment vehicle
Interventions
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LEO 90100
Betamethasone plus calcipotriol
Ointment vehicle
LEO 90100 vehicle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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LEO Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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John Koo, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco School of Medicine
Locations
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Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Dermatology Research Associates
Los Angeles, California, United States
Dermatology Specialists, Inc.
Oceanside, California, United States
Skin Surgery Medical Group, Inc
San Diego, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
About Skin Dermatology and DermSurgery, PC
Denver, Colorado, United States
Colorado Medical Research Center, Inc
Denver, Colorado, United States
Horizons Clinical Research Center
Denver, Colorado, United States
Dermatology Associates and Research
Coral Gables, Florida, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Ameriderm Research
Ormond Beach, Florida, United States
Gwinnett Clinical Research Ctr, Inc
Snellville, Georgia, United States
Altman Dermatology Associates
Arlington Heights, Illinois, United States
Glazer Dermatology
Buffalo Grove, Illinois, United States
Clinical Research Advantage, Inc./Hudson Dermatology, LLC
Evansville, Indiana, United States
Dawes Fretzin Clinical Research Group
Indianapolis, Indiana, United States
The Indiana Clinical Trials Center
Plainfield, Indiana, United States
Owensboro Dermatology Associates
Owensboro, Kentucky, United States
David Fivenson, MD, PLC
Ann Arbor, Michigan, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Derm Center
Troy, Michigan, United States
Grekin Skin Institute
Warren, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Psoriasis Treatment Center of Central NJ
East Windsor, New Jersey, United States
The Dermatology Group, PC
Verona, New Jersey, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Derm Research Center of New York
Stony Brook, New York, United States
Philadelphia Institute of Dermatology
Fort Washington, Pennsylvania, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Countries
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References
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Koo J, Tyring S, Werschler WP, Bruce S, Olesen M, Villumsen J, Bagel J. Superior efficacy of the fixed combination calcipotriene plus betamethasone dipropionate in a novel aerosol foam versus ointment in patients with psoriasis vulgaris. Semin Cutan Med Surg. 2015;34 S1:PA-42.
Iversen L, Kurvits M, Snel-Prento AM, Menter A. Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA >/= 3: Post-Hoc Analysis From Three Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Oct;10(5):1111-1120. doi: 10.1007/s13555-020-00419-2. Epub 2020 Aug 12.
Related Links
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Clinical Trials at LEO Pharma
Other Identifiers
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LEO 90100-35
Identifier Type: -
Identifier Source: org_study_id
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