UMIN-CTR Clinical Trial

Basic information
Public title	Effects of an Ultrasound Focusing Device for Noncontact Force Radiation on Hair.
Acronym	Effects of an Ultrasound Focusing Device for Noncontact Force Radiation on Hair.
Scientific Title	Effects of an Ultrasound Focusing Device for Noncontact Force Radiation on Hair.
Scientific Title:Acronym	Effects of an Ultrasound Focusing Device for Noncontact Force Radiation on Hair.
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of an ultrasound focusing device for noncontact force radiation for hair.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Analysis of the number of hairs, the hair density, and the anagen:telogen ratio with TrichoScan (Week 0 and just after hair cutting, Week 0 and 3 days after hair cutting, Week 16 and just after hair cutting, Week 16 and 3 days after hair cutting).
Key secondary outcomes	*Secondary outcomes [1]Gene expression test on a hair cycle (Week 0 and just after hair cutting, Week 16 and just after hair cutting). [2]Questionnaire of physical feeling (Week 0 and just after hair cutting, Week 16 and just after hair cutting). *Safety [1]Visual examination of head by a medical doctor (Screening, Week 0 and just after hair cutting, Week 16 and just after hair cutting). [2]Doctor's questions (Screening, Week 0 and just after hair cutting, Week 16 and just after hair cutting). [2]Subject's diary (From the first day of ingestion of a test material to the last day of the test).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Radiating an ultrasound on measurement point (20 minutes / time; 16 times).
Interventions/Control_2	Nonradiating an ultrasound on measurement point (20 minutes / time; 16 times).
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	30 years-old >
Gender	Male
Key inclusion criteria	[1]Healthy Japanese females aged 20-29 years. [2]Individuals who are healthy and have no chronic physical disease including skin disease. [3]Individuals whose working space is indoors. [4]Individuals whose written informed consent has been obtained. [5]Individuals who can have an examination on a designated check day. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals with thinning hair or male pattern baldness. [3] Individuals with skin disease, such as atopic dermatitis on scalp. [4]Individuals who used a drug to treat Androgenetic Alopecia in the past 3 months. [5]Individuals who used a drug to treat a disease in the past 1 month. [6]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [7]Individuals who contract or have a history of serious gastrointestinal disease. [8]Individuals whose BMI is over 30.0. [9]Individuals who have a habit to use a similar treatment with the test method or other hair growth promotion method. [10]Individuals who have an addiction to alcohol or a mental illness. [11]Individuals with possible changes of life style during the test period. [12]Individuals who participated in other clinical studies in the past 3 months. [13]Individuals judged inappropriate for the study by the principal.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	ANGFA 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
Email	jimukyoku@tes-h.co.jp

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	2019 Year 12 Month 05 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	Completed
Date of protocol fixation	2019 Year 11 Month 01 Day
Date of IRB	2019 Year 11 Month 06 Day
Anticipated trial start date	2019 Year 12 Month 13 Day
Last follow-up date	2020 Year 04 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 12 Month 05 Day
Last modified on	2021 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044223