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

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2022
INTERVENTION: 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. CONDITION: Female Pattern Hair Loss ; FPHL 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 INCLUSION 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
Epistemonikos ID: 7084e3809d00ea0976d087bcef194c7b3eba53cd
First added on: Aug 26, 2024