Alopecia
Conditions
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.
Interventions
DEVICE1565nm 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.
Sponsors
Lumenis Be Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Ukraine
Outcome results
None listed