PS10-FPHL study
- Conditions
- FPH
- Registration Number
- JPRN-jRCTs032220646
- Lead Sponsor
- Miyata Akinobu
- Brief Summary
The test product was used continuously for 12 weeks to evaluate the condition of female pattern hair loss patients aged 40 years and older. As a result, compared to the non-intervention group, the test product group showed significant improvement in hair diameter and head condition after 12 weeks. In comparison with before use, significant improvements were seen in the condition of the head after 8 weeks and in the hair diameter and condition of the head after 12 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 27
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hair diameter, crown evaluation, equipment measurement(number and density of hair)
- Secondary Outcome Measures
Name Time Method subjective assessment