Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis
- Registration Number
- NCT01908595
- Lead Sponsor
- Maruho North America Inc.
- Brief Summary
This study is to evaluate the efficacy and safety for long term use of M518101 in subjects with plaque psoriasis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
- Who are able and willing to give signed informed consent
- 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.
- Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description M518101 M518101 Proper quantity twice daily
- Primary Outcome Measures
Name Time Method Time course change of Investigator Global Assessment 4 weeks interval
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Dermatology and Aesthetic Center Skin Care
🇺🇸Boca Raton, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Peachtree Dermatology Associates Research Center
🇺🇸Atlanta, Georgia, United States
Northshore University Health System
🇺🇸Skokie, Illinois, United States
PMG Research of Bristol
🇺🇸Kingsport, Tennessee, United States
Dermatology Associates of Knoxville
🇺🇸Knoxville, Tennessee, United States
Horizons Clinical Research Center
🇺🇸Denver, Colorado, United States
Bakersfield Dermatology and Skin Cancer Medical Group
🇺🇸Bakersfield, California, United States
FXM Research Miramar
🇺🇸Miramar, Florida, United States
Suzanne Bruce & Associates
🇺🇸Houston, Texas, United States
USF Health Morsani Center for Advanced Healthcare
🇺🇸Tampa, Florida, United States
Bager Allergy, Asthma and Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Agave Clinical Research
🇺🇸Mesa, Arizona, United States
ATS Clinical Research
🇺🇸Santa Monica, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
PMG research of raleigh
🇺🇸Cary, North Carolina, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Stephen Miller
🇺🇸San Antonio, Texas, United States
J Woodson Dermatology and Associates
🇺🇸Henderson, Nevada, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
South bend clinic
🇺🇸South Bend, Indiana, United States
New York University
🇺🇸New York, New York, United States
Madison Skin & Research
🇺🇸Madison, Wisconsin, United States
Dermatology Research Center
🇺🇸Salt Lake City, Utah, United States
Research Across America
🇺🇸Plano, Texas, United States
Kansas City Dermatology
🇺🇸Overland Park, Kansas, United States
The skin wellness center
🇺🇸Knoxville, Tennessee, United States
Radiant Research
🇺🇸Cincinnati, Ohio, United States