PS10-FPHL study

JRCT ID: jRCTs032220646

Registered date:17/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: FPHL
• Date of first enrollment: 01/03/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Subjects are divided into two groups (test article use group, non-intervention group) to evaluate the effects on hair.

Outcome(s)

• Primary Outcome: Hair diameter, crown evaluation, equipment measurement(number and density of hair)
• Secondary Outcome: subjective assessment

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 59age old
• Gender: Female

Include criteria

1. Female Pattern Hair Loss (FPHL) over 40 years old (including FAGA and alopecia areata)
2.Persons whose parietal condition corresponds to I-2 to II-1 on the Savin Female Density scale
3. When using the test equipment, test that you do not put or wear electronic products (including smartphones, chargers, music players, earphones, mobile games, etc.) within 1m from your body (including the next room across the wall). Those who can continue during the implementation period
4. Those who can promise not to wear metal objects (accessories, buttons, watches, hairpins, etc.) when using the test equipment.
5. Those who can promise not to wear chemical fiber clothing (polyester, nylon, vinyl, fleece, etc.) when using the test equipment (bedding such as 100% cotton or silk pajamas is acceptable)
6.Subjects who can use 100% cotton or linen sheets at bedtime during the test period.
7.Subjects who fully understood the participation in this research and gave written informed consent of their own free will.

Exclude criteria

1.Subjects with symptoms of atopic dermatitis
2. Those who are receiving treatment, medication, or lifestyle guidance from a doctor
3. Severe cerebrovascular disease, heart disease, liver disease, renal disease, digestive system disease, infectious disease requiring notification, etc. suffering from
4. Those who use a pacemaker or defibrillator
5. Excessive smokers*1 and regular alcohol users*2
6.Subjects with significant abnormalities in blood pressure measurement and blood tests
7. Those who are pregnant or breast-feeding, or those planning to do so (including those who have just given birth)
8.Subjects who are receiving hormone replacement therapy
9.Subjects who plan to start new hair care (hair restorer, thinning hair treatment, hair beauty treatment, etc.) during the test period, or those who have started within the last 2 months
10. Subjects who have experience of aesthetic medicine on the test site, and who have hair thickening
11.Subjects who plan to change their lifestyle habits during the test period
12.Subjects who have participated in, or plan to participate in, other clinical trials that are affected by this study within one month prior to obtaining informed consent
13.In addition, those who are judged to be inappropriate by the principal investigator

Related Information

• Primary Sponsor: Miyata Akinobu
• Source(s) of Monetary Support: WellenKraft Inc.