UMIN-CTR Clinical Trial

Basic information
Public title	A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Acronym	A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Scientific Title	A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Scientific Title:Acronym	A study to evaluate the topical maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Region	Japan

Condition
Condition	Plaque Psoriasis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine efficacy, safety and patient's satisfaction of maintenance therapy after treatment with topical fixed combination drug in patients with plaque psoriasis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	mPASI (modified Psoriasis Area and Severity Index) score and improvement rate
Key secondary outcomes	Total PSI (Psoriasis Severity Index) score and improvement rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Topical combined containing vitamin D3 and corticosteroid
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Clinical diagnosis of plaque psoriasis amenable to topical treatment for psoriasis lesion except for head, face and neck. (2)A target lesion of scoring at least 3 for each of redness, thickness and scale, and at least 10 in total (3)Patients who have 3 - 10% body surface area (BSA) (4)16 years of age or above (5)Patients who signed informed consent after receiving sufficient explanation and agreement of participation of this study (6)If the patient is of minors, written informed consent by the legal guardian should be obtained.
Key exclusion criteria	(1)Serious drug hypersensitivity or history of allergic reaction against maxacalcitol or betamethasone butyrate propionate (2)Patients who have skin disease with bacterium, fungus, spirochaete, virus or skin disease with animal (3)Patients who have ulceration, burn, cold injury (4)Patients who have hypercalcemia (5)Patients who have renal function deterioration (6)Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding (7)Patients who participated in other clinical study within 4 months prior to starting this study (8)Patients who received topical treatment of psoriasis lesion except for head, face and neck within 14 days before starting this study (9)1)Ultraviolet therapy within 28 days before starting this study. 2)Systemic treatments (e.g., vitamin D analogues, retinoids, ciclosporin, apremilast) within 28 days before starting this study. (10)Systemic use of biological treatments with a potential effect on psoriasis vulgaris within the following time periods prior to starting this study: 1)secukinumab:150 days 2)ustekinumab:120 days 3)infliximab, adalimumab, ixekizumab, brodalumab:90 days 4)other products -90 days/5 half-lives (whichever is longer). (11)Planned initiation of, or changes in, concomitant medication that may affect psoriasis vulgaris (e.g., beta-blockers, antimalaria drugs and lithium) during the study. (12)Those who the investigator or sub-investigator judges are ineligible
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hajime Iizuka
Organization	Kojinkai, Association of Medical Corporation Research Institute of Psoriasis Hosui General Medical Clinic
Division name	Dermatology
Zip code
Address	1-4,Nishi2-chome,minami7-jo,Chuo-ku, Sapporo-shi, Hokkaido, Japan
TEL	011-520-2310
Email	iizuka_hajime_chiken@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Ryoichi Tsubouchi
Organization	Linical Co., Ltd.
Division name	Contract Medical Affairs, Clinical Trial Division
Zip code
Address	1-6-1, Miyahara, Yodogawa-ku,
TEL	06-6150-2332
Homepage URL
Email	tsubouchi-ryoichi@linical.co.jp

Sponsor
Institute	Kojinkai, Association of Medical Corporation
Institute
Department

Funding Source
Organization	Maruho Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 19 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036112

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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