This is a single center, prospective, open label clinical trial with before-after study design. The study is designed to evaluate the feasibility of hair growth in female and male pattern hair loss (androgenic alopecia, telogen effluvium, and alopecia areata) using a fractional non-ablative 1565nm ResurFX module.
This is a single center, prospective, open label clinical trial with before-after study design. The study is designed to evaluate the feasibility of hair growth in female and male pattern hair loss (androgenic alopecia, alopecia areata) using a fractional non-ablative 1565nm ResurFX module. This study will include up to 13 visits at the clinic: screening; at least 5 and up to 10 treatment (Tx) visits 14+/-3 days apart, and follow up (FU) visits at 1 and 3 months (each can be +/-7 days out of window) after the last treatment session. See Figure 3: Study Design for an illustration of the study design, for a summary of the study procedures and Table 1 for the schedule of times and events. The study population will include up to 35 healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber.
AMG
Lviv, Ukraine
Hair Density Improvement
evaluate the change in hair density in the target area hair count between baseline and follow up (at 1 month following last treatment), as assessed by scalp macro-imaging.
Time frame: week 0 and week 24 week follow up
Subjective Improvement
Subjective global assessment of hair regrowth by subjects and the investigator at 1 and 3 months following last treatment using a 5-point improvement scale
Time frame: 24 week and 32 week follow up
Hair Density Improvement
Change in hair density in the target area between baseline and 3 month following last treatment, as assessed by scalp macro-imaging.
Time frame: week 0 and week 32 week follow up
Adverse events
Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events
Time frame: week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32
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