Fractional Non-ablative Laser for the Treatment of Hair Loss

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Alopecia

Intervention / Treatment
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* Device: 1565nm non ablative fractional laser


Participation Criteria
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Eligibility Criteria
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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: Male presenting Norwood Hamilton Scale - Stage 1 and up to 4 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: Male presenting Norwood Hamilton Scale - Stage 5 and up to 7 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scalp treatment with ResurFX<br> | Device: 1565nm non ablative fractional laser<br>* The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber.<br>* Other names: ResurFX by Lumenis Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | week 0 and week 24 week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32 |