fractional non-ablative laser for the treatment of hair loss

Conditions: Alopecia

Summary: 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.

Eligibility criteria:
inclusion criteria: * subjects with noticeable alopecia of the following types: androgenic alopecia, telogen effluvium and alopecia areata * experiencing active hair loss within the last 1 months but no longer than 5 years * male/female hair pattern loss base on: 1. male presenting norwood hamilton scale - stage 1 and up to 4 2. female presenting sinclair grade i-iv * subjects in general good health * male and female, age 18-45 years old * women of child-bearing potential that agree to abstain from pregnancy or breastfeeding during the course of the study * women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, nuvaring, partner with vasectomy, implanon or other approved devices, or abstinence) at least 3 months prior to enrollment and throughout the course of the study * willing to remain on the same diet/habits (per physician recommendation) * subject is willing and able to comply with protocol requirements and all study visits * subject is willing and able to provide a written informed consent exclusion criteria: * male/female hair pattern loss base on: 1. male presenting norwood hamilton scale - stage 5 and up to 7 2. female presenting sinclair grade v * subjects who suffer from scarring alopecia or alopecia totalis * women who are pregnant, lactating, or less than 6 months post-lactation completion, possibly pregnant or planning a pregnancy during the study period * currently participating in or recently participated in another clinical trial (within the last 90 days) * has photosensitivity to laser treatment previous/current alopecia treatment * has used during the six months prior to screening or is currently on any of the following medications: finasteride (or any other 5α-reductase inhibitor medications), medications with anti-androgenic properties, topical estrogen, progesterone, tamoxifen, anabolic steroids, medications which can potential cause hypertrichosis, oral glucocorticoids, lithium, phenothiazines, or other medication at the discretion of the investigator * has used during 6 months prior to screening or is currently on minoxidil * has used oral phytotherapy within 2 months prior to study treatment area related * subject who color (any type of dye) their hair less than 2 weeks prior to treatment and can't withhold dying their hair during the course of the treatment period. * has any active skin infection in the scalp or scarring * has had hair transplants, scalp reduction, current hair weave or tattooing in the target area, which makes it difficult to perform treatment and assessments * has a chronic dermatological condition (eczema, psoriasis, infection, etc.) of the scalp * has ever received radiation therapy to the scalp medical conditions * history of cancer with the exception of (1) successfully treated basal cell or squamous cell carcinoma of the skin or (2) subjects with a history of successfully treated cancer that have been disease-free for five years (not in the treatment area) * any current cancer, or has had chemotherapy in the past year * bleeding disorders and/or using anti-platelet and anticoagulant medication * uncontrolled systemic disease (diabetes) or infection * history of hypogonadism * has significant systemic illness * has a known underlying medical problem that could influence hair growth such as hiv infection, connective tissue disease, a thyroid condition, inflammatory bowel disease or other medical conditions, at the discretion of the investigator. * has used accutane in the past 6 months * has a history of poor wound healing * has a history of keloid formation * has a history or evidence of heavy smoking (more than 1 package/20 cigarettes a day), any drug and/or alcohol abuse (over 500ml of 40% hard liquor a week) within the 12 months prior to study * significant concurrent illness that, in the investigator's opinion would interfere with the subject's participation in the study.