The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6
Male and females between 21 - 55 years of age, inclusive.
Have Fitzpatrick Skin Type V to VI.
Have mild to moderate hair loss (Ludwig scale I-II for women, Norwood-Hamilton scale I-III for males)
Have self-reported thinning or hair loss for more than 6 months prior to screening but less than 5 years.
Clinical diagnosis of alopecia areata or scarring forms of alopecia
Patient is of skin type I-IV
Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy. Subjects of childbearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as postmenopausal (e.g.: absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy
Single group
FoLix treatment for improving the scalp hair appearance
DeviceThe study patients will receive 4 FoLix treatment in 4 weeks intervals. the scalp hair improvement will be evaluated by 3 blinded assessors who shall review before and after images, as well as hair count data
improvement in scalp hair appearance by comparing before and after images
The primary endpoint, the proportion of picture sets correctly classified as before/after by at least 2 of the 3 blinded reviewers, will be summarized by a count a percentage with exact two-sided 95% confidence interval. If the lower limit is greater than 70%, the null hypothesis will be rejected, and the endpoint will be deemed successfully met. There will be no formal interim statistical analysis.
Hair count values
The degree of improvement in hair quality and quantity using trichoscopic analyses will be based on the following: * Terminal to Vellus Ratio * Average hairs per follicular unit * Average hair width (mm) * Inter-follicular mean distance (mm) * Improvement in scalp hair appearance (blinded reviewers)
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