Hair Regrowth Effects in Patients with Female Pattern Alopecia by Non-contact Focused Ultrasound

JRCT ID: jRCTs032220402

Registered date:21/10/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Female Pattern Hair Loss
• Date of first enrollment: 22/11/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): To verify the effect of non-contact focused ultrasound irradiation on hair growth using the half-head method, the subjects were shaved into a circle 2 cm in diameter with an electric shaver on the left and right parietal areas of the head where hair was thinning (the boundary between the area with hair and the area where hair was thinning). The ultrasound irradiation area was randomized, and each subject was irradiated with ultrasound waves using a non-contact focused ultrasound device on one side of a 2-cm diameter circle, while the opposite circle was not irradiated. The opposite circle will not be ultrasonically irradiated. To identify the shaved area, a marker will be used to mark the area when shaving the hair.

Outcome(s)

Primary Outcome

Phototrichogram evaluation of the test site at 12 and 24 weeks (percentage of growing hairs)
Growth phase hair percentage: The growth phase hair percentage was calculated by determining the number of growth phase hairs immediately after shaving and 3 days later within a shaved area of 2 cm in diameter.

Secondary Outcome

Efficacy endpoints
Phototrichogram evaluation (hair density, hair diameter, and hair growth) at the test site at Weeks 12 and 24
Hair density: Total number of hairs (per square meter) immediately and 3 days after shaving.
Hair diameter: Diameter of hairs from the thickness of growing hairs immediately after shaving and 3 days after shaving.
Hair elongation: Length of hair immediately after shaving and 3 days after shaving.
The phototrichogram evaluation range shall be the same as that within the shaved area of 2 cm in diameter for the main evaluation item.

Safety endpoints
Confirmation of neurological symptoms (headache, dizziness, lightheadedness) by a physician

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 50age old
• Gender: Female

Include criteria

1. Japanese female subjects who are between 20 and 50 years of age at the time of obtaining written conse
nt to participate in the study and who have an understanding of the study
2. have FPHL (Savin classification: II-III, Advanced)
3. who are able to shave the evaluation site and come to the clinic for the procedure
4. who can come to the hospital on the designated examination and treatment days and undergo the examination
5. who are basically engaged in indoor work
6. who have explained about the study using the consent document and obtained consent

Exclude criteria

1. those with anemia, thyroid disease, collagen disease, polycystic ovaries, hyperprolactinemia, or other conditions that cause symptoms of hair loss
2. those who consume excessive amounts of alcohol
3. those whose lifestyle may change during the examination period (e.g., working at night, traveling for long periods of time)
4. who have participated in other clinical trials or clinical studies from the past 6 months to the present
5. who are currently undergoing treatment for FPHL (medication, hair transplantation, etc.)
6. who have been determined to have alopecia due to postpartum
7. who have used drugs such as RiUP for the treatment of female pattern baldness within the past 3 months
8. those who have skin conditions such as skin allergies, atopic dermatitis, seborrheic dermatitis, etc. on the scalp
9. Women who are pregnant or may become pregnant, or who wish to become pregnant during the study period
10. any other person whom the principal investigator or subinvestigator determines to be inappropriate to participate in this study.

Related Information

• Primary Sponsor: Yoshihiro Yasuda
• Secondary Sponsor: ANGFA Co., Ltd.