Fractional Non-ablative Laser for the Treatment of Hair Loss
- Conditions
- Alopecia
- Interventions
- Device: 1565nm non ablative fractional laser
- Registration Number
- NCT04953416
- Lead Sponsor
- Lumenis Be Ltd.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 31
-
Subjects with noticeable alopecia of the following types: androgenic alopecia, telogen effluvium and alopecia areata
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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
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Subjects in general good health
-
Male and female, age 18-45 years old
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Women of child-bearing potential that agree to abstain from pregnancy or breastfeeding during the course of the study
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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)
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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
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Male/Female hair pattern loss base on:
- Male presenting Norwood Hamilton Scale - Stage 5 and up to 7
- Female presenting Sinclair Grade V
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Subjects who suffer from scarring alopecia or alopecia totalis
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Women who are pregnant, lactating, or less than 6 months post-lactation completion, possibly pregnant or planning a pregnancy during the study period
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Scalp treatment with ResurFX 1565nm non ablative fractional laser -
- Primary Outcome Measures
Name Time Method Hair Density Improvement week 0 and week 24 week follow up 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.
- Secondary Outcome Measures
Name Time Method Adverse events week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32 Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events
Subjective Improvement 24 week and 32 week follow up 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
Hair Density Improvement week 0 and week 32 week follow up Change in hair density in the target area between baseline and 3 month following last treatment, as assessed by scalp macro-imaging.
Trial Locations
- Locations (1)
AMG
🇺🇦Lviv, Ukraine