UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications	https://www.shinryo-to-shinyaku.com/db/pdf/sin_0059_05_0253.pdf
Number of participants that the trial has enrolled	25
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 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 07 Month 05 Day

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