Actively Recruiting
Clinical Study to Evaluate Hair Loss Improvement in Skin of Color Using Fractional Non-Ablative Laser
Led by Lumenis Be Ltd. · Updated on 2026-01-02
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of a fractional non-ablative laser device called the FoLix laser system, which uses Erbium:Glass Fiber Laser Technology at a wavelength of 1565 nm, on hair loss improvement in healthy adults aged 21 to 55 years with moderate hair loss and Fitzpatrick skin types 5 or 6. This study aims to expand the FDA approval of this device, which is already approved for skin types 1 to 4, by assessing its safety and effectiveness for people with darker skin tones experiencing hair thinning. Participants will receive four treatments with the FoLix laser spaced four weeks apart. The study will evaluate changes in scalp hair appearance by comparing before and after images reviewed by three blinded assessors, alongside hair count measurements. The treatments involve the use of the FDA-cleared laser device targeting the scalp area affected by hair loss, and the study is designed to monitor outcomes over a 12-month period. During the study, participants will attend all scheduled visits for treatment and assessments. These include scalp examinations, digital imaging using a smart camera, and hair count assessments to track progress. Participants are also required to maintain consistent hair styling and shampoo use during the trial. Safety and improvement outcomes will be measured primarily by visual scalp hair appearance and hair count data after 12 months. The total duration of involvement for each participant is one year from the start of treatment.
CONDITIONS
Brief Title
Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 21 and 55 years old inclusive
- Fitzpatrick Skin Type V or VI
- Mild to moderate hair loss (Ludwig scale I-II for women, Norwood-Hamilton scale I-III for men)
- Self-reported hair thinning or loss for more than 6 months but less than 5 years
- Clinically confirmed hair loss or thinning by physical exam
- No prior hair-loss treatments or participation in a study using 1565 NAFL device
- Good general health as determined by investigator
- Willing and able to attend all study visits
- Willing to maintain the same hairstyle throughout the study
- Willing to use mild non-medicated shampoo and conditioner during study
- Negative urine pregnancy test at screening and use of effective contraception for women of childbearing potential
- Able and willing to cooperate with study requirements including specialized imaging
- Able to understand and complete study rating instruments in English
- Sponsor approved global image assessment of hair thinning or loss
You will not qualify if you...
- Diagnosis of alopecia areata or scarring alopecia
- Skin type I-IV
- Scalp hair loss due to disease, injury, or medical therapy in treatment area
- Pregnant, planning pregnancy, breastfeeding, or not using approved contraception if of childbearing potential
- Current scalp skin disease or conditions that may interfere with study or pose risk
- Prior participation in 1565 NAFL studies or treatments
- History of hair loss surgery or hair transplants
- Use of hair growth products or anti-androgenic therapies within specified timeframes before baseline
- History of scalp irritation symptoms or severe dandruff
- History of malignancy (except certain skin cancers) or recent chemotherapy/radiation
- Autoimmune thyroid or other autoimmune disorders that might interfere
- Untreated or uncontrolled depression, bipolar disorder, or conditions impacting participation
- Recent use of low level lasers for hair loss treatment
- Any condition posing risk or interference as judged by investigator
- Involvement in injury litigation claims
- Known iron deficiency, bleeding disorders, platelet dysfunction, anticoagulant therapy, or heavy smoking
- Use of medications potentially causing hair loss or affecting hair growth as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive 4 FoLix laser treatments for hair loss, each spaced 4 weeks apart.
4 treatment visits (in-person) spaced 4 weeks apart
Duration - Up to 12 months
Participants are monitored for hair loss improvement and safety for up to 12 months after treatment.
Visits at intervals for hair count and image assessments
Trial Site Locations
Total: 1 location
1
UnionDerm
New York, New York, United States, 10003
Actively Recruiting
Research Team
K
Keren Hayut
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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