Efficacy Study Comparing Topical M518101 and Vitamin D3 in Adult Psoriasis Patients
NCT ID: NCT01989429
Last Updated: 2015-12-31
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
788 participants
INTERVENTIONAL
2013-10-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis.
Based on the results of previous phase II trials the phase III trial has been designed to evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger population of patients with stable plaque psoriasis.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Daivonex
topical application
M518101
8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse
vehicle
topical application
M518101
8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse
M518101
topical application
M518101
8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
M518101
8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Psoriasis patients with up to 20% affected body surface area ( BSA) (not including face or scalp)
* Investigator Global Assessment(IGA) of moderate to severe and who are suitable for topical therapy
Exclusion Criteria
* Patients with known allergic reactions, irritations or sensitivity to vitamin D3 derivatives drug hypersensitivity to other components of the investigational products;
* Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) salicylic acid within 14 days of randomization
* Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial
* Patients whose calcium test at screening exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone);
* Patients who have used any study drug (including experimental biologics) and/or participated in any clinical trial within the last 60 days before the day of randomization
* Patients who have been treated with any biologics for their psoriasis within 30 days or 5 half-lives (whichever is longer) of the biologic before the day of randomization the longest documented half-life of the biologic should be used to calculate the 5 half-lives;
* Patients who have been treated with phototherapy (laser, oral steroids, oral retinoid, oral immunosuppressive/immunomodulative drugs, cytostatics, cyclosporine or methotrexate within 30 days of randomization
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maruho Co., Ltd.
INDUSTRY
Maruho Europe Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
D Thaci, Prof.Dr
Role: PRINCIPAL_INVESTIGATOR
University of Lubeck, Dermatology Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universitätsklinik für Dermatologie und Venerologie,
Graz, , Austria
DCC "Chaika" EOOD
Varna, , Bulgaria
Universitatsklinikum Schleswig-Holstein
Lübeck, , Germany
Semmelweis Hospital
Miskolc, Csabai Kapu 9-11,, Hungary
PI Hospital of Lithuanian University of Health Sciences
Kaunas, , Lithuania
CSK MON Wojskowego Instytutu Medycznego
Warsaw, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-001632-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M518101-EU04
Identifier Type: -
Identifier Source: org_study_id