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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036874
Receipt No. R000042012
Scientific Title Skin patch testing of hair and skincare products to the normal volunteer.
Date of disclosure of the study information 2019/05/28
Last modified on 2019/09/25

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Basic information
Public title Skin patch testing of hair and skincare products to the normal volunteer.
Acronym Skin patch testing of hair and skincare products to the normal volunteer.
Scientific Title Skin patch testing of hair and skincare products to the normal volunteer.
Scientific Title:Acronym Skin patch testing of hair and skincare products to the normal volunteer.
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Dermatology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate irritative reaction of new cosmetic products.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Patch testing
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Patch testing of 35 samples using fin-chamber for 48 hours on volunteer's back.
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 Healthy volunteer
Key exclusion criteria 1.Patients who are hospitalized or use steroid ointment.

2.Under the pregnancy

3.Patients who have eczema it their back and a patch test is difficult.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Funasaka
Organization Nippon medical school hospital
Division name Dermatology
Zip code 113-8602
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email funasaka@nms.ac.jp

Public contact
Name of contact person
1st name Hidehisa
Middle name
Last name Saeki
Organization Nippon medical school hospital
Division name Dermatology
Zip code 113-8602
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Homepage URL
Email h-saeki@nms.ac.jp

Sponsor
Institute Nippon medical school hospital

Institute
Department

Funding Source
Organization MOCHIDA HEALTHCARE 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 Nippon Medical School Hospital IRB
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel 03-3822-2131
Email clinicaltrial@nms.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
2019 Year 05 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 29 Day
Date of IRB
2019 Year 05 Month 13 Day
Anticipated trial start date
2019 Year 05 Month 29 Day
Last follow-up date
2019 Year 09 Month 24 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 09 Month 09 Day
Date analysis concluded
2019 Year 09 Month 24 Day

Other
Other related information

Management information
Registered date
2019 Year 05 Month 28 Day
Last modified on
2019 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042012

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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