Fractional Non-ablative Laser for the Treatment of Hair Loss

NCT04953416 | Unknown

• 1 other identifier: LUM-ABU-M22-ResurFX-19-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Subjective Improvement

  24 week and 32 week follow up

• Hair Density Improvement

  week 0 and week 32 week follow up

• Adverse events

  week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32

Study Arms (1)

Scalp treatment with ResurFX

EXPERIMENTAL

Device: 1565nm non ablative fractional laser

Interventions

1565nm non ablative fractional laser 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.

Also known as: ResurFX by Lumenis Ltd.

Scalp treatment with ResurFX

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Male presenting Norwood Hamilton Scale - Stage 1 and up to 4
• 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

You may not qualify if:

• Male/Female hair pattern loss base on:
• Male presenting Norwood Hamilton Scale - Stage 5 and up to 7
• 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

Sponsors & Collaborators

• Lumenis Be Ltd.: lead

Study Sites (1)

AMG

Lviv, 79044, Ukraine

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Olga Yarish, MD

  AMG clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: September 8, 2020
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 8, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)