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

This study has been completed.
Sponsor:
Information provided by:
Maruho Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00884169
First received: April 17, 2009
Last updated: November 2, 2010
Last verified: November 2010
  Purpose

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


Condition Intervention Phase
Plaque Psoriasis
Drug: M518101
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind

Resource links provided by NLM:


Further study details as provided by Maruho Co., Ltd.:

Primary Outcome Measures:
  • Severity of plaque psoriasis

Secondary Outcome Measures:
  • Investigator and Patient overall assessment

Study Start Date: July 2009
Estimated Study Completion Date: December 2009
Intervention Details:
    Drug: M518101
    Proper quantity twice a day
    Drug: placebo
    Proper quantity twice a day
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884169

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

No publications provided

Responsible Party: R&D Administration Department, Maruho Co.,Ltd ・Kyoto R&D Center
ClinicalTrials.gov Identifier: NCT00884169     History of Changes
Other Study ID Numbers: M518101-EU03
Study First Received: April 17, 2009
Last Updated: November 2, 2010
Health Authority: Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014