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. Identifier: NCT00884169
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : November 3, 2010
Information provided by:
Maruho Co., Ltd.

Brief Summary:
This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: M518101 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Study Start Date : July 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Intervention Details:
    Drug: M518101
    Proper quantity twice a day
    Drug: placebo
    Proper quantity twice a day

Primary Outcome Measures :
  1. Severity of plaque psoriasis

Secondary Outcome Measures :
  1. Investigator and Patient overall assessment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884169

United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Maruho Co., Ltd.

Responsible Party: R&D Administration Department, Maruho Co.,Ltd ・Kyoto R&D Center Identifier: NCT00884169     History of Changes
Other Study ID Numbers: M518101-EU03
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases