Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients
NCT ID: NCT01301157
Last Updated: 2015-11-05
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
PHASE2
294 participants
INTERVENTIONAL
2011-02-28
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
DOUBLE
Study Groups
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25ug M518101
M518101
Proper quantity twice a day
Vehicle
placebo
Proper quantity twice a day
Dovonex
Dovonex
Proper quantity twice a day
50ug M518101
M518101
Proper quantity twice a day
Interventions
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M518101
Proper quantity twice a day
placebo
Proper quantity twice a day
Dovonex
Proper quantity twice a day
Eligibility Criteria
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Inclusion Criteria
2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.
3. Who have less than 20% of body surface area (BSA) afflicted with plaques
4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.
Exclusion Criteria
2. Who have a history of relevant drug hypersensitivity.
3. Who have a history of contact dermatitis induced by a topical medicine.
4. Who are pregnant or lactating.
5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
6. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.
7. 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.
8. Whose serum calcium levels exceed the upper limit of reference range
9. Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.
10. Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.
11. Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.
12. Who have been treated with topical therapy during the wash-out period.
18 Years
ALL
No
Sponsors
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Maruho Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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University of Alabama (UAB) Dermatology
Birmingham, Alabama, United States
Coastal Carolina Research
Mobile, Alabama, United States
Sierra Medical Research
Fresno, California, United States
Therapeutics Clinical Research
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Visions Clinical Research
Boynton Beach, Florida, United States
Ameriderm Research
Jacsonville, Florida, United States
Ameriderm Research
Ormond Beach, Florida, United States
Atlanta Dermatology, Vein & Research Ctr
Alpharetta, Georgia, United States
NorthShore University HealthSystem
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
The Southbend Clinic, LLC
South Bend, Indiana, United States
Derm Research
Louisville, Kentucky, United States
Medical Development Centers, LLC
Baton Rouge, Louisiana, United States
Medical Development Centers, LLC
Opelousas, Louisiana, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, United States
Central Dermatology
St Louis, Missouri, United States
Washington University, Dermatology Clinical Trials Unit
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center, Section of Dermatology
Lebanon, New Hampshire, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
DermResearchCenter of New York, Inc
Stony Brook, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
Radiant Research
Columbus, Ohio, United States
OUHSC-Dermatology
Oklahoma City, Oklahoma, United States
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, United States
Palmetto Clinical Trial Services, LLC
Greenville, South Carolina, United States
Arlington Research Center, Inc
Arlington, Texas, United States
Center for Clinical Studies, Texas Medical Center
Houston, Texas, United States
Dermatology Clinical Research Center
San Antonio, Texas, United States
Virginia Clinical Research Inc.
Norfolk, Virginia, United States
Dermatology Associates
Seattle, Washington, United States
Countries
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Other Identifiers
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M518101-US01
Identifier Type: -
Identifier Source: org_study_id
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