Hair LossNCT06885112
Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser
A study testing FoLix treatment for improving the scalp hair appearance in people with Hair Loss, run by Lumenis Be Ltd. at 1 site in United States.
Trial summary
The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6 Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hair Loss
- What is being tested?
- FoLix treatment for improving the scalp hair appearance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to 21 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and females between 21 - 55 years of age, inclusive.
- Have Fitzpatrick Skin Type V to VI.
- Have mild to moderate hair loss (Ludwig scale I-II for women, Norwood-Hamilton scale I-III for males)
- Have self-reported thinning or hair loss for more than 6 months prior to screening but less than 5 years.
- Clinically confirmed to have hair loss or thinning by the investigator via physical exam
- Didn't receive hair-loss treatments or participated in a clinical study using 1565 NAFL device
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- In good general health, as determined by the Investigator
- Willing and able to attend all study visits
- Willing to maintain the same hair style as at the Screening Visit for the duration of the study. If coloring hair, willing to color it with the same frequency of usage as in the past, making sure not to color within 1-week before and 1-week after an in-office appointment
- Willing to use a mild non-medicated shampoo and conditioner for the duration of the study (medicated shampoo and conditioner refer to any prescription shampoo or conditioner as well as any over-the counter medicated shampoo or conditioner, such as those for treatment of dandruff or promoting hair growth)
- Have a negative urine pregnancy test at screening and be using, and continue to use for the duration of the study, an effective contraception method (i.e., abstinence, barrier control, intrauterine device [IUD], or hormonal [estrogen/progestin] contraceptives) for at least one menstrual cycle prior to study; if using IUD or hormonal contraceptives - then at least 2 years prior to screening, the initiation of which should not have been associated with initiation of hair loss/thinning.
- Be willing and able to cooperate with the requirements of the study including images taken using a smart camera (multi-spectral) of several skin conditions
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board
- Be able to complete and understand the various rating instruments in English
- Sponsor approved global image assessment of degree of thinning / hair loss
Who cannot join
- Clinical diagnosis of alopecia areata or scarring forms of alopecia
- Patient is of skin type I-IV
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy. Subjects of childbearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as postmenopausal (e.g.: absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy
- Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
- Participated in a previous 1565 NAFL study or treatment
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- History of surgical correction of hair loss on the scalp/ Hair transplants.
- Use of any products or devices purported to promote scalp hair growth (e.g., finasteride or minoxidil) within the 90 days prior to the Baseline Visit.
- Use of anti-androgenic therapies (e.g., spironolactone, flutamide, cyproterone acetate, cimetidine) within 60 days prior to the Baseline Visit.
- No history of burning, flaking, itching, and stinging of the scalp.
- A chronic condition of high severity dandruff.
- History of malignancy (except scc and bcc skin cancers) or undergoing chemotherapy or radiation treatments.
- A known history of autoimmune thyroid disease, any other thyroid disorder/abnormality or other autoimmune disorders that in the opinion of the investigator may interfere with the study treatment.
- A known history of untreated or uncontrolled depression or bipolar disease or any other condition that may impact the subject's participation.
- Recent utilization of low level lasers for treating hair loss (past 6 months).
- Has any condition that the treating investigator or PI thinks may put the Subject at risk or interfere with their participation in the study.
- Is involved in any injury litigation claims.
- Known history or recent bloodwork indicating iron deficiency (ferritin level is less than 30 ng/mL), bleeding disorders or platelet dysfunction syndrome as well as subjects receiving anticoagulant therapy or smokers with usage >20 cigarettes/day.
- Use of any medications that are known to potentially cause hair loss or affect hair growth, as determined by PI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UnionDerm
New York, New York, 10003
Anne Chapas, MD, Medical Doctor, 212-366-5400, research@unionderm.com
Anne Chapas, MD, Medical Doctor
About this study
The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6
Read the detailed description
The FoLix laser system contains Erbium:Glass Fiber Laser Technology with a wavelength of 1565 nm. It is the first FDA cleared fractional laser device for treatment of hair loss that has demonstrated safety and efficacy.
- Conditions
- Hair Loss
- Being tested
- FoLix treatment for improving the scalp hair appearance
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FoLix treatment for improving the scalp hair appearanceDevice
The study patients will receive 4 FoLix treatment in 4 weeks intervals. the scalp hair improvement will be evaluated by 3 blinded assessors who shall review before and after images, as well as hair count data
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects with moderate hair loss stage and skin color type 5 or 6 | Experimental | The FoLix is FDA cleared for hair loss treatments in patients with skin type 1 to 4. It is no being studied for patients with skin type 5 and 6 to allow expending the product labeling Receives: Device: FoLix treatment for improving the scalp hair appearance |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in scalp hair appearance by comparing before and after images
The primary endpoint, the proportion of picture sets correctly classified as before/after by at least 2 of the 3 blinded reviewers, will be summarized by a count a percentage with exact two-sided 95% confidence interval. If the lower limit is greater than 70%, the null hypothesis will be rejected, and the endpoint will be deemed successfully met.
There will be no formal interim statistical analysis.
Measured: 12 months
Secondary outcomes (1)
Hair count values
The degree of improvement in hair quality and quantity using trichoscopic analyses will be based on the following:
- Terminal to Vellus Ratio
- Average hairs per follicular unit
- Average hair width (mm)
- Inter-follicular mean distance (mm)
- Improvement in scalp hair appearance (blinded reviewers)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start21 Feb 2025
- Primary completion21 Feb 2027 (estimated)
- Study completion21 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumenis Be Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885112
- Sponsor's protocol ID
- LUM-ABU-FoLix-24-01
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Improvement in Hair Loss in Skin of Color Treated With Fractional Non-Ablative Laser
- ClinicalTrials.gov ID
- NCT06885112
- Acronym / sponsor ID
- LUM-ABU-FoLix-24-01
- Conditions
- Hair Loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lumenis Be Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 21 Feb 2027 (estimated)
- Study completion
- 21 Feb 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6
Detailed description
The FoLix laser system contains Erbium:Glass Fiber Laser Technology with a wavelength of 1565 nm. It is the first FDA cleared fractional laser device for treatment of hair loss that has demonstrated safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subjects with moderate hair loss stage and skin color type 5 or 6 | Experimental | Device: FoLix treatment for improving the scalp hair appearanceThe FoLix is FDA cleared for hair loss treatments in patients with skin type 1 to 4. It is no being studied for patients with skin type 5 and 6 to allow expending the product labeling |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Male and females between 21 - 55 years of age, inclusive.
- Have Fitzpatrick Skin Type V to VI.
- Have mild to moderate hair loss (Ludwig scale I-II for women, Norwood-Hamilton scale I-III for males)
- Have self-reported thinning or hair loss for more than 6 months prior to screening but less than 5 years.
- Clinically confirmed to have hair loss or thinning by the investigator via physical exam
Key exclusion criteria (19 listed)
- Clinical diagnosis of alopecia areata or scarring forms of alopecia
- Patient is of skin type I-IV
- Scalp hair loss on the treatment area, due to disease, injury, or medical therapy
- Subjects who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy. Subjects of childbearing potential who are not using an approved method of birth control (oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide or abstinence). Females of non-childbearing potential are defined as postmenopausal (e.g.: absence of menstrual bleeding for one year), hysterectomy or bilateral oophorectomy
- Current skin disease (e.g., psoriasis, atopic dermatitis, skin cancer, eczema, sun damage, seborrheic dermatitis), cuts and or abrasions on the scalp or condition (e.g., sunburn, tattoos) on the treatment area that, in the opinion of the Investigator, might put the subject at risk or interfere with the study conduct or evaluations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FoLix treatment for improving the scalp hair appearanceThe study patients will receive 4 FoLix treatment in 4 weeks intervals. the scalp hair improvement will be evaluated by 3 blinded assessors who shall review before and after images, as well as hair count data | Device | healthy subjects with moderate hair loss stage and skin color type 5 or 6 |
Primary outcome
improvement in scalp hair appearance by comparing before and after images
Time frame: 12 months
The primary endpoint, the proportion of picture sets correctly classified as before/after by at least 2 of the 3 blinded reviewers, will be summarized by a count a percentage with exact two-sided 95% confidence interval. If the lower limit is greater than 70%, the null hypothesis will be rejected, and the endpoint will be deemed successfully met. There will be no formal interim statistical analysis.
1 secondary outcome
Hair count values
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FoLix treatment for improving the scalp hair appearance in people with Hair Loss, run by Lumenis Be Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keren Hayut (+972506905252, keren.hayut@lumenis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in scalp hair appearance by comparing before and after images (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.