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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033934
Receipt No. R000038675
Scientific Title Study of concentration base of patch test/prick test
Date of disclosure of the study information 2018/08/29
Last modified on 2019/08/30

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Basic information
Public title Study on Establishment of Allergy Confirmation Method for Cosmetics and others
Acronym Study on Establishment of Allergy Confirmation Method for Cosmetics and others
Scientific Title Study of concentration base of patch test/prick test
Scientific Title:Acronym patch test/prick test
Region
Japan

Condition
Condition Contact dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, in order to speed up the investigation of the cause when a new adverse event occurs in the future, we conduct epidemiological studies of case information on adverse events that occurred in quasi-drugs, cosmetics etc.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigate and analyze defect cases in skin and body such as contact dermatitis in Japan.
Key secondary outcomes 1.Search for harmful cases
2.Sensitization rate of contact dermatitis allergens
3.Number of cases by region
4.Number of occupational skin disorder cases
5.Comparison with past data

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Implement patch test
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Object
Allergy / photoallergic contact dermatitis, allergic contact urticaria (syndrome), protein contact dermatitis, immediate allergy by ingestion, irritant / irritant / allergic contact erythema (syndrome) due to products and chemical substances used routinely such as cosmetics, Understanding the purpose of this research and notifying the applicant in written form, in patients who are suffering skin and body disorders such as phototoxic contact dermatitis, vitiligo / depigmenting plaques, chemical burns, etc., satisfying certain qualification criteria and not meeting exclusion criteria Children aged (under 20 years old) and adults (over 20 years old)
Selection criteria
1) Patients should have skin disorder induced by any substance / product applied / contacted to the skin.
2) Be patient who is willing to comply with the research implementation plan.
3) Sign the consent form approved by the Ethics Review Committee of the medical institution conducting the trial
about.
Key exclusion criteria A patient whose research doctor judges that participation in research is inappropriate
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Kayoko
Middle name
Last name Matsunaga
Organization Fujita Health University School of Medicine
Division name Department of Integrative Medical Science for Allergic Disease
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
TEL 0562-93-9441
Email kamatsu@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Kayoko
Middle name
Last name Matsunaga
Organization Fujita Health University School of Medicine
Division name Department of Integrative Medical Science for Allergic Disease
Zip code 470-1192
Address 1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
TEL 0562-93-9441
Homepage URL
Email kamatsu@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Fujita Health University School of Medicine
Address 1-98, Dengakugakubo, Kutsukake-cho Toyoake, Aichi 470-1192
Tel 0562932865
Email f-irb@fujita-hu.ac.jp

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 08 Month 29 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 01 Month 25 Day
Date of IRB
2014 Year 07 Month 31 Day
Anticipated trial start date
2014 Year 07 Month 31 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 08 Month 29 Day
Last modified on
2019 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038675

Research Plan
Registered date File name
2019/03/07 3.研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2019/08/30 報告書データ (3).pptx


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