UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of stratum corneum structure before and after administration of biopharmaceutics in Psoriasis vulgaris patients
Acronym	Evaluation of stratum corneum structure before and after administration of biopharmaceutics in Psoriasis vulgaris patients
Scientific Title	Evaluation of stratum corneum structure before and after administration of biopharmaceutics in Psoriasis vulgaris patients
Scientific Title:Acronym	Evaluation of stratum corneum structure before and after administration of biopharmaceutics in Psoriasis vulgaris patients
Region	Japan

Condition
Condition	Psoriasis vulgaris, Arthropathy of psoriasis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the stratum corneum structure before and after biopharmaceutics in psoriasis patient
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between composition and structure of stratum coreum and clinical condition (PASI score)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Evaluation of the stratum corneum structure before and after biopharmaceutics in psoriasis patients The stratum corneum of patients will be removed by tape stripping method on day 0, 14, 28, 56, 84, 112 and 140 after starting biopharmaceutcal formulation therapy and be analyzed.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients who are diagnosed with vulgarity or arthropathic psoriasis 2. More than 20-years olds patients at the time of enrollement
Key exclusion criteria	1. Patients with a history of allergy for the biopharmaceutics 2. Patients who are considered to be inappropriate in enrollment of this trial by attending physicians
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tomonobu Middle name Last name Uchino
Organization	University of Shizuoka
Division name	Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences,
Zip code	4228526
Address	52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL	054-264-5771
Email	uchinot@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Tomonobu Middle name Last name Uchino
Organization	University of Shizuoka
Division name	Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences,
Zip code	422-8526
Address	52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL	054-264-5771
Homepage URL
Email	uchinot@u-shizuoka-ken.ac.jp

Sponsor
Institute	Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences, University of Shizuoka
Institute
Department

Funding Source
Organization	University of Shizuoka
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shizuoka general hospital
Address	4-27-1 kitaando aoi-ku shizuoka-shi Shizuoka, Japan
Tel	054-247-6111
Email	chiken-sougou@shizuoka-pho.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	SGHIRB#2016081
Org. issuing International ID_1	Shizuoka general hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 07 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	Enrolling by invitation
Date of protocol fixation	2017 Year 09 Month 28 Day
Date of IRB	2017 Year 01 Month 13 Day
Anticipated trial start date	2017 Year 09 Month 28 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 12 Month 07 Day
Last modified on	2020 Year 06 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034599