Fractional Non-ablative Laser for the Treatment of Hair Loss
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Scalp treatment with ResurFX
|
Device: 1565nm non ablative fractional laser
The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Male/Female hair pattern loss base on:
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Male presenting Norwood Hamilton Scale - Stage 1 and up to 4
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Female presenting Sinclair Grade I-IV
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Subjects in general good health
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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
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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
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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
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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)
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Has photosensitivity to laser treatment
Previous/Current Alopecia Treatment
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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
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Has used during 6 months prior to screening or is currently on Minoxidil
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Has used oral phytotherapy within 2 months prior to study
Treatment area related
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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.
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Has any active skin infection in the scalp or scarring
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Has had hair transplants, scalp reduction, current hair weave or tattooing in the target area, which makes it difficult to perform treatment and assessments
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Has a chronic dermatological condition (eczema, psoriasis, infection, etc.) of the scalp
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Has ever received radiation therapy to the scalp
Medical Conditions
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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)
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Any current cancer, or has had chemotherapy in the past year
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Bleeding disorders and/or using anti-platelet and anticoagulant medication
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Uncontrolled systemic disease (diabetes) or infection
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History of hypogonadism
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Has significant systemic illness
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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.
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Has used Accutane in the past 6 months
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Has a history of poor wound healing
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Has a history of keloid formation
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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
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Significant concurrent illness that, in the investigator's opinion would interfere with the subject's participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AMG | Lviv | Ukraine | 79044 |
Sponsors and Collaborators
- Lumenis Ltd.
Investigators
- Principal Investigator: Olga Yarish, MD, AMG clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LUM-ABU-M22-ResurFX-19-01