Fractional Non-ablative Laser for the Treatment of Hair Loss

NCT ID: NCT04953416

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2022-03-31

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.

Conditions

Alopecia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Scalp treatment with ResurFX

Group Type: EXPERIMENTAL

1565nm non ablative fractional laser

Intervention Type: DEVICE

The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ResurFX by Lumenis Ltd.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olga Yarish, MD

Role: PRINCIPAL_INVESTIGATOR

AMG clinic

Locations

AMG

Lviv, , Ukraine

Countries

Ukraine

Other Identifiers

LUM-ABU-M22-ResurFX-19-01

Identifier Type: -

Identifier Source: org_study_id