Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
NCT ID: NCT01908595
Last Updated: 2015-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
480 participants
INTERVENTIONAL
2013-08-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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M518101
Proper quantity twice daily
M518101
Interventions
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M518101
Eligibility Criteria
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Inclusion Criteria
* Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
* Who have up to 20% of body surface area (BSA) afflicted with plaques
* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
Exclusion Criteria
* Who are pregnant or lactating.
* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
* Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study.
* Whose serum calcium levels exceed the upper limit of reference range
* Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of treatment.
* Who have been treated with systemic therapy within 30days of treatment.
* Who have treated with biologics within 5 half-lives of the biologics before the day of treatment
* Who have been treated with topical therapy within 14days before the day of treatment.
18 Years
ALL
No
Sponsors
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Maruho North America Inc.
INDUSTRY
Responsible Party
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Locations
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Agave Clinical Research
Mesa, Arizona, United States
Bakersfield Dermatology and Skin Cancer Medical Group
Bakersfield, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Medical Center for Clinical Research
San Diego, California, United States
ATS Clinical Research
Santa Monica, California, United States
Horizons Clinical Research Center
Denver, Colorado, United States
Dermatology and Aesthetic Center Skin Care
Boca Raton, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
FXM Research Miramar
Miramar, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Peachtree Dermatology Associates Research Center
Atlanta, Georgia, United States
Northshore University Health System
Skokie, Illinois, United States
South bend clinic
South Bend, Indiana, United States
Kansas City Dermatology
Overland Park, Kansas, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
J Woodson Dermatology and Associates
Henderson, Nevada, United States
New York University
New York, New York, United States
PMG research of raleigh
Cary, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Radiant Research
Cincinnati, Ohio, United States
Bager Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States
PMG Research of Bristol
Kingsport, Tennessee, United States
Dermatology Associates of Knoxville
Knoxville, Tennessee, United States
The skin wellness center
Knoxville, Tennessee, United States
Suzanne Bruce & Associates
Houston, Texas, United States
Research Across America
Plano, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Stephen Miller
San Antonio, Texas, United States
Dermatology Research Center
Salt Lake City, Utah, United States
Madison Skin & Research
Madison, Wisconsin, United States
Countries
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Other Identifiers
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M518101-US04
Identifier Type: -
Identifier Source: org_study_id
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