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Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00884169
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : November 3, 2010
Information provided by:

April 17, 2009
April 20, 2009
November 3, 2010
July 2009
Not Provided
Severity of plaque psoriasis
Same as current
Complete list of historical versions of study NCT00884169 on ClinicalTrials.gov Archive Site
Investigator and Patient overall assessment
Same as current
Not Provided
Not Provided
Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
Not Provided
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.
Not Provided
Phase 2
Allocation: Randomized
Masking: Double
Plaque Psoriasis
  • Drug: M518101
    Proper quantity twice a day
  • Drug: placebo
    Proper quantity twice a day
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Not Provided
December 2009
Not Provided

Inclusion Criteria:

  • Who are able and willing to give signed informed consent
  • Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.
  • Who have less than 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 have a history of allergy to vitamin D3 derivative preparations.
  • Who have a history of relevant drug hypersensitivity.
  • Who have a history of contact dermatitis induced by a topical medicine.
  • Who are pregnant or lactating.
  • Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.
  • 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 24 weeks
  • Who have been treated with systemic therapy within 8 weeks
  • Who have been treated with biologics within 12 weeks
  • Who have been treated with topical therapy during the wash-out and lead-in period.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Not Provided
R&D Administration Department, Maruho Co.,Ltd ・Kyoto R&D Center
Maruho Co., Ltd.
Not Provided
Not Provided
Maruho Co., Ltd.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP