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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046532
Receipt No. R000053094
Scientific Title Improvement effects on scalp and hair by medicated hair restorer containing 5 kinds of active ingredients: single blinded study
Date of disclosure of the study information 2022/01/06
Last modified on 2022/01/04

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Basic information
Public title Improvement effects on scalp and hair by medicated hair restorer containing 5 kinds of active ingredients
Acronym New POLYPURE study
Scientific Title Improvement effects on scalp and hair by medicated hair restorer containing 5 kinds of active ingredients: single blinded study
Scientific Title:Acronym Improvement effects on scalp and hair by medicated hair restorer containing 5 kinds of active ingredients
Region
Japan

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

Objectives
Narrative objectives1 Use test article for 4 weeks to assess the condition of hair and scalp
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes evaluation of scalp condition, hair thickness measurement
Key secondary outcomes subjective assessment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Using test article for 4 consecutive weeks
Interventions/Control_2 Life as usual for a certain period of time
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
59 years-old >=
Gender Male and Female
Key inclusion criteria 1.Subjects who feel that hair has become thin
2.Males from "Type II" to "Type IV" in the Hamilton-Norwood classification
3.Females from "I-2" to "I-4" in Olsen (Christmas tree) type
Key exclusion criteria 1.Subjects with rash and inflammation throughout the scalp
2.Subjects planning to receive treatment or special treatment on AGA,FPHL treatment and scalp, hair during the study period
3.Subjects who plan to start new use and intake of hair restorer and food related to hair growth during the test period
4.Subjects with cosmetic allergies
5.Subjects who is participating in other human exams within the past 4 weeks
6.Subjects who are judged as unsuitable for the study by the investigator for the other reason
Target sample size 26

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 160-0022
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 CSC 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 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
2022 Year 01 Month 06 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
2021 Year 11 Month 25 Day
Date of IRB
2021 Year 12 Month 02 Day
Anticipated trial start date
2022 Year 01 Month 06 Day
Last follow-up date
2022 Year 02 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 04 Day
Last modified on
2022 Year 01 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053094

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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