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
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
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
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
