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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044162
Receipt No. R000050432
Scientific Title Effect on the scalp by using a hair dryer with a scalp care function : single blinded study
Date of disclosure of the study information 2021/05/17
Last modified on 2021/11/08

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Basic information
Public title Effect on the scalp by using a hair dryer with a scalp care function
Acronym T dryer study
Scientific Title Effect on the scalp by using a hair dryer with a scalp care function : single blinded study
Scientific Title:Acronym Effect on the scalp by using a hair dryer with a scalp care function
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the effects of using a hair dryer on the scalp
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes moisture content, sebum content, volume of hair, stratum corneum condition
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Using test article for 12 consecutive weeks
Interventions/Control_2 Using a control article without scalp care function for 12 weeks
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
50 years-old >=
Gender Male and Female
Key inclusion criteria 1.Subjects with a length of 10 cm or more from the root of the hair to the tip of the hair (male)
2.Subjects whose length from the root of the hair to the tip of the hair is below the shoulder to above the waist (female)
3.Subjects who are worried about the amount of sebum, dryness, and itching of the scalp
4.Subjects that tend to cause redness and rashes on the skin
Key exclusion criteria 1. Pregnant and lactating
2. Subjects with inflammation or scratches on the forehead or scalp
3. Subjects with sensitive skin
4. Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Masatomo
Middle name
Last name Najima
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Email info@yakujihou.org

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code 1600022
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
TEL 0364574666
Homepage URL
Email info@yakujihou.org

Sponsor
Institute Japan Clinical Trial Association
Institute
Department

Funding Source
Organization YA-MAN 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 Institutional Review Board of Pharmaceutical Law Wisdoms
Address 5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo
Tel 0364574911
Email master@yakujihou.net

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
2021 Year 05 Month 17 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 29
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
2021 Year 03 Month 16 Day
Date of IRB
2021 Year 04 Month 15 Day
Anticipated trial start date
2021 Year 05 Month 17 Day
Last follow-up date
2021 Year 08 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 10 Day
Last modified on
2021 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050432

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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