UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038797
Receipt number R000044223
Scientific Title Effects of an Ultrasound Focusing Device for Noncontact Force Radiation on Hair.
Date of disclosure of the study information 2019/12/05
Last modified on 2021/06/07 12:11:50

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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 or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044223


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name