LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris
- Conditions
- Psoriasis Vulgaris
- Interventions
- Registration Number
- NCT01536886
- Lead Sponsor
- LEO Pharma
- Brief Summary
The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 376
- 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.
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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)
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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.
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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.
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PUVA therapy within 4 weeks prior to randomisation.
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UVB therapy within 2 weeks prior to randomisation.
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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.
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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.
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Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
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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.
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Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris.
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Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
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Known or suspected severe renal insufficiency or severe hepatic disorders.
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Known or suspected hypersensitivity to component(s) of the investigational products.
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Current participation in any other interventional clinical study.
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Previously randomised in this study.
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Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ointment vehicle Ointment vehicle Ointment with no active ingredients LEO 90100 vehicle LEO 90100 vehicle Aerosol foam with no active ingredient Betamethasone plus calcipotriol Betamethasone plus calcipotriol Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment LEO 90100 LEO 90100 LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
- Primary Outcome Measures
Name Time Method Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4. 4 weeks Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
Menter Dermatology Research Institute
🇺🇸Dallas, Texas, United States
International Dermatology Research, Inc.
🇺🇸Miami, Florida, United States
Dawes Fretzin Clinical Research Group
🇺🇸Indianapolis, Indiana, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, 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 Trials of Texas, Inc
🇺🇸San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Clinical Research Advantage, Inc./Hudson Dermatology, LLC
🇺🇸Evansville, Indiana, United States
Philadelphia Institute of Dermatology
🇺🇸Fort Washington, Pennsylvania, United States
The Dermatology Group, PC
🇺🇸Verona, New Jersey, United States
Psoriasis Treatment Center of Central NJ
🇺🇸East Windsor, New Jersey, United States
North Florida Dermatology Associates, PA
🇺🇸Jacksonville, Florida, United States
Glazer Dermatology
🇺🇸Buffalo Grove, Illinois, United States
Ameriderm Research
🇺🇸Ormond Beach, Florida, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Derm Research Center of New York
🇺🇸Stony Brook, New York, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Dermatology Associates and Research
🇺🇸Coral Gables, Florida, United States
Gwinnett Clinical Research Ctr, Inc
🇺🇸Snellville, Georgia, United States
Owensboro Dermatology Associates
🇺🇸Owensboro, Kentucky, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, 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
Horizons Clinical Research Center
🇺🇸Denver, Colorado, United States
Colorado Medical Research Center, Inc
🇺🇸Denver, Colorado, United States
David Fivenson, MD, PLC
🇺🇸Ann Arbor, Michigan, United States
Dermatology Research Center, Inc.
🇺🇸Salt Lake City, Utah, United States
About Skin Dermatology and DermSurgery, PC
🇺🇸Denver, Colorado, United States
Derm Center
🇺🇸Troy, Michigan, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States