UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030294 |
|---|---|
| Receipt number | R000034599 |
| Scientific Title | Evaluation of stratum corneum structure before and after administration of biopharmaceutics in Psoriasis vulgaris patients |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2020/06/23 14:14:44 |
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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
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
uchinot@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmaceutics, School of Pharmaceutical Sciences, University of Shizuoka
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034599
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
