Effects of an Ultrasound Focusing Device for Noncontact Force Radiation on Hair.

Not Applicable

• Conditions: /A(healthy adults)

• Registration Number: JPRN-UMIN000038797
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-05
• Study Completion: 2020-04-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[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).

Secondary Outcome Measures

Name	Time	Method
*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).