臨床研究等提出・公開システム

Date of registration	June. 25, 2015
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080222894

Scientific Title	M518101 phase III study in plaque psoriasis patients
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Maruho Co.,Ltd Kyoto R&D Center
	Address	ctinfo@mii.maruho.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design	Multi-center, positive controlled, randomized, double-blind, parallel-group, non-inferiority
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Patients diagnosed with plaque psoriasis
	Exclusion Criteria
	Minimum Age	16age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Plaque psoriasis
Intervention(s)		investigational material(s) Generic name etc : M518101 INN of investigational material : Therapeutic category code : 269 Other agents for epidermis Dosage and Administration for Investigational material : Proper quantity once a day control material(s) Generic name etc : maxacalcitol ointment INN of investigational material : Therapeutic category code : 269 Other agents for epidermis Dosage and Administration for Investigational material : Proper quantity twice a day
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		severity of plaque psoriasis
Secondary Outcome

Primary Sponsor	Maruho Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-152946
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	April. 20, 2016	Detail	Changes
3	April. 20, 2016	Detail	Changes
2	June. 25, 2015	Detail	Changes
1	June. 25, 2015	Detail

List of change history