臨床研究等提出・公開システム

Effect on Female Pattern Hair Loss by health equipment "RAYOCOMP"

PS10-FPHL study

27

Group A; n15(Female), 51.8years-old (Active) Group B; n12(Female), 49.2years-old (placebo)

28 started the study. 27 completed the study.

no

Hair diameter: Group A showed a significant difference in increase compared to Group B after 12 weeks. In comparison with before use, group A showed a significant increase after 12 weeks. Group B showed a significant decrease after 12 weeks. Head condition: Group A showed a significant difference in increase compared to Group B after 12 weeks. When compared with before use, group A showed a significant increase after 8 and 12 weeks. Group B showed a significant increase after 4 weeks. Total number of hairs, hair density, and percentage of anagen hairs: No significant differences were observed. Subjective assessment: Group A showed a significant increase in 5 items after 8 weeks and 2 items after 12 weeks when compared with Group B. In comparison with before use, there was a significant increase in 1 item after 4 weeks, 4 items after 8 weeks, and 6 items after 12 weeks. No significant changes were observed in Group B. No adverse events were observed in this study.

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.

Nov. 30, 2023

Nov. 30, 2023

No

no

https://jrct.mhlw.go.jp/latest-detail/jRCTs032220646

Miyata Akinobu

Miyata Medical Clinic

9F, 2-2-8 Nihonbashi, Chuoku, Tokyo

nihonbashi.ms.cl@gmail.com

Kaneko Takeshi

Japan Clinical Trial Association

5F, 4-3-17 Shinjuku, Shinjukuku, Tokyo

+81-3-6302-0593

kaneko@usjri.com

Complete

Mar. 01, 2023

Interventional

randomized controlled trial

single blind

no treatment control/standard of care control

parallel assignment

treatment purpose

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

Female

FPHL

Subjects are divided into two groups (test article use group, non-intervention group) to evaluate the effects on hair.

Hair diameter, crown evaluation, equipment measurement(number and density of hair)

subjective assessment

+81-3-5326-3129

Feb. 16, 2023

none