Fractional Non-ablative Laser for the Treatment of Hair Loss

Lumenis

Status

Unknown

Conditions

Alopecia

Treatments

Device: 1565nm non ablative fractional laser

Study type

Interventional

Funder types

Industry

Identifiers

NCT04953416

LUM-ABU-M22-ResurFX-19-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.