Fractional Non-ablative Laser for the Treatment of Hair Loss

Evaluation of Safety and Performance of Fractional Non-ablative Laser for the Treatment of Hair Loss - A Pilot Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alopecia
• Intervention / Treatment: Device: 1565nm non ablative fractional laser

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Lviv, Ukraine, 79044
    • AMG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: ResurFX by Lumenis Ltd.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hair Density Improvement	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.	week 0 and week 24 week follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Improvement	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	24 week and 32 week follow up
Hair Density Improvement	Change in hair density in the target area between baseline and 3 month following last treatment, as assessed by scalp macro-imaging.	week 0 and week 32 week follow up
Adverse events	Skin safety throughout the study as determined by the investigator by examining the post-treatment occurrences of complications and adverse events	week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: Olga Yarish, MD, AMG clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): July 8, 2021
• Last Update Submitted That Met QC Criteria: July 6, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: LUM-ABU-M22-ResurFX-19-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: As this is a feasibility evaluation we do not want to publish yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No