Skip to main content
OpenTrials
Completed

NCT Number: NCT00884169

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

M518101

Drug

Proper quantity twice a day

Placebo

Drug

Proper quantity twice a day

Primary outcomes

  1. Severity of plaque psoriasis

Secondary outcomes

  1. Investigator and Patient overall assessment

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Important dates

Study start
2009
Study completion
2009
First posted
Apr 20, 2009
Registry last updated
Nov 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.