UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Survey on the current status of treatment of subjective symptoms and the use of topical agents in patients receiving therapy for plaque psoriasis
Title of the study (Brief title)	Survey on the current status of treatment of subjective symptoms and the use of topical agents in patients receiving therapy for plaque psoriasis
Region	Japan

Condition
Condition	psoriasis vulgaris
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to understand how the availability of a new topical compound consisting of active vitamin D3 and steroid affects treatment and patient satisfaction in clinical practice.
Basic objectives2	Others
Basic objectives -Others	Actual condition survey
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- Treatment strategies for plaque psoriasis - Satisfaction with treatment
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	- Patients aged 20 years or older who are diagnosed with plaque psoriasis - Patients who are scheduled to start at least 4 weeks of treatment with a topical compound consisting of active vitamin D3 and steroid or who are currently treated with the compound
Key exclusion criteria	- Patients without plaque psoriasis - Patients under the age of 20 years - Patients who are not scheduled to be treated with a topical compound consisting of active vitamin D3 and steroid
Target sample size	1000

Research contact person
Name of lead principal investigator	Osamu Nemoto
Organization	Sapporo dermatology Clinic
Division name	Director
Address	5th Floor, H&B Plaza Building, 2-1-1 Minami Sanjo Nishi, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	011-221-8807
Email	sapporo@kojinkai.org

Public contact
Name of contact person	Eri Muto
Organization	QOL RD Co.,Ltd.
Division name	Clinical Development Group 1 CRO Department Drug Division
Address	Front Place Nihonbashi Bldg. 2-14-1, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL	03-6386-8801
Homepage URL
Email	tsgp-study@qol-rd.co.jp

Sponsor
Institute	Topical-therapy Survey Study Group for Psoriasis
Institute
Department

Funding Source
Organization	LEO Pharma K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 06 Day
Anticipated trial start date	2014 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	- Treatment strategies for plaque psoriasis - Satisfaction with treatment

Management information
Registered date	2015 Year 01 Month 19 Day
Last modified on	2017 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018841