Clinical trial NCT04953416: Fractional Non-ablative Laser for the Treatment of Hair Loss
Official title: Evaluation of Safety and Performance of Fractional Non-ablative Laser for the Treatment of Hair Loss - A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alopecia
Lead sponsor: Lumenis Be Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hair Density Improvement
timeFrame: week 0 and week 24 week follow up
Secondary outcomes:
measure: Subjective Improvement
timeFrame: 24 week and 32 week follow up
measure: Hair Density Improvement
timeFrame: week 0 and week 32 week follow up
measure: Adverse events
timeFrame: week: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 32
Other outcomes:
Locations:
city: Lviv
country: Ukraine
facility: AMG
Study officials:
affiliation: AMG clinic
name: Olga Yarish, MD
role: PRINCIPAL_INVESTIGATOR
References: