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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032490
Receipt No. R000037051
Scientific Title Effect of depilation on arms and legs using lotion containing soymilk
Date of disclosure of the study information 2018/05/08
Last modified on 2018/05/07

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Basic information
Public title Effect of depilation on arms and legs using lotion containing soymilk
Acronym Effect of depilation on arms and legs using lotion containing soymilk
Scientific Title Effect of depilation on arms and legs using lotion containing soymilk
Scientific Title:Acronym Effect of depilation on arms and legs using lotion containing soymilk
Region
Japan

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

Objectives
Narrative objectives1 Evaluate the effect on body hair when using lotion for 4 weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of body hair condition before starting use of test article and 4 weeks after use
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 Prevention
Type of intervention
Other
Interventions/Control_1 Using cosmetic lotion for 4 consecutive weeks
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
59 years-old >=
Gender Male and Female
Key inclusion criteria 1.Subjects suffering from unwanted hair on arms and legs
2.During the test period, subjects who can consent to use the test article only on one side of the left and right
Key exclusion criteria 1.Subjects with cosmetic allergies
2.Subjects who are pregnant or lactating
3.Within 3 years, subjects with experiences of depilation treatment/medical depilation on the test site(arm, leg)
4.Subjects who have hair removal/hair removal schedule for arms and legs during the test period
5. Subjects using products effective for depilation / depilation, subjects scheduled to use
Target sample size 18

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

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Kaneko
Organization Japan Clinical Trial Association
Division name N.A.
Zip code
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 Suzuki Herb Laboratory 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 05 Month 08 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 04 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 08 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 05 Month 07 Day
Last modified on
2018 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037051

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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