Fractional Non-ablative Laser for the Treatment of Hair Loss

Evaluation of Safety and Performance of Fractional Non-ablative Laser for the Treatment of Hair Loss - A Pilot Study

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.

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.