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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034326
Receipt No. R000039137
Scientific Title Safety test by patch test of SMH hair foundation (RUAN)
Date of disclosure of the study information 2018/10/03
Last modified on 2018/09/29

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Basic information
Public title Safety test by patch test of SMH hair foundation (RUAN)
Acronym Safety test of SMH hair foundation
Scientific Title Safety test by patch test of SMH hair foundation (RUAN)
Scientific Title:Acronym Safety test of SMH hair foundation
Region
Japan

Condition
Condition gray hair
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 safety test
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety test of SMH hair foundation
Confirm skin reaction (contact dermatitis)
Key secondary outcomes Not applicable

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 Vaseline
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
30 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria 1)30 to 60-year-old man
2)People application site (upper arm) is a healthy skin
3)People who consent is obtained in writing with respect to participation in the study
Key exclusion criteria 1)People allergic to the product of components and medical tape, to the magic
2)People with eczema on the upper arm (patch test application site)
3)People who take oral steroids and anti-allergic agents
4)Others, who has been determined to be inappropriate as a target by the judgment of the practitioner
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Shimizu
Organization Gunma university hospital
Division name Department of dermatology
Zip code
Address 3-39-22 Showamachi, Maebashi
TEL 0272208284
Email shimizuakira@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Shimizu
Organization Gunma university hospital
Division name Department of dermatology
Zip code
Address 3-39-22 Showamachi, Maebashi
TEL 0272208284
Homepage URL
Email shimizuakira@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization RUAN 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 10 Month 03 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
2018 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 05 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 09 Month 29 Day
Last modified on
2018 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039137

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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