Laser Treatment for Alopecia

Overseen By Keren Hayut

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lumenis Be Ltd.

Must not be taking: Finasteride, Minoxidil, Anti-androgens, others

Disqualifiers: Alopecia areata, Skin disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new laser treatment, FoLix, to determine its effectiveness for hair loss in individuals with darker skin tones (Fitzpatrick skin types 5 and 6). The goal is to expand its use to these skin types, as it is already approved for lighter ones. The trial seeks healthy individuals aged 21-55 who have experienced mild to moderate hair thinning for over six months but less than five years. Participants should not have recently tried other hair loss treatments and must be willing to maintain the same hairstyle during the study. As an unphased trial, this study offers a unique opportunity to contribute to expanding treatment options for diverse skin types.

Will I have to stop taking my current medications?

The trial requires that you stop using any products or medications that promote hair growth, like finasteride or minoxidil, at least 90 days before starting. You also need to stop anti-androgenic therapies, like spironolactone, 60 days before. If you're on medications known to cause hair loss, you may need to stop those as well.

What prior data suggests that this laser treatment is safe for individuals with skin type 5 or 6?

Research has shown that the FoLix laser system is safe for promoting hair growth in adults. The FDA has approved it for individuals with lighter skin tones (types 1 to 4), confirming its safety for these groups. Currently, the treatment is being tested on individuals with darker skin tones (types 5 and 6) to assess its safety for them as well.

Studies have found that low-level laser treatments like FoLix are generally well-tolerated. This technology stimulates hair regrowth by activating hair follicles. So far, research has not identified any major harmful side effects, supporting its safety for a broader population. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for hair loss, like minoxidil and finasteride, work by promoting hair growth or slowing hair loss, often with mixed results depending on the individual's skin type. The FoLix laser treatment is unique because it uses laser technology that directly stimulates hair follicles, potentially offering a more targeted approach. Researchers are excited about FoLix because it is being explored for effectiveness in individuals with skin types 5 and 6, expanding options for those who have been underrepresented in previous treatments. This could lead to more inclusive hair loss solutions, catering to a wider range of people.

What evidence suggests that the FoLix treatment might be an effective treatment for hair loss in patients with skin type 5 or 6?

Research has shown that the FoLix treatment, which participants in this trial will receive, effectively treats hair loss. Earlier studies found a 10-18% increase in hair thickness after using FoLix. The FDA has approved this laser system for individuals with lighter skin tones (types 1 to 4), confirming its safety and effectiveness. Results can vary based on the advancement of hair loss and treatment frequency. Discontinuing the treatment may lead to resumed hair loss, so consistent use is important to maintain results. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 21-55 with skin types V to VI who have mild to moderate hair loss. Participants must not have used hair-loss treatments recently, be in good health, and willing to follow study requirements like using non-medicated shampoo and attending all visits.

Inclusion Criteria

My doctor has confirmed I have hair loss or thinning.

In good general health, as determined by the Investigator

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

Exclusion Criteria

Use of any products or devices purported to promote scalp hair growth within the 90 days prior to the Baseline Visit

Patient is of skin type I-IV

Subjects who are pregnant, planning to become pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fractional non-ablative laser treatment for hair loss

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FoLix treatment

Trial Overview The FoLix treatment is being tested on individuals with certain types of hair loss. The goal is to see if this fractional non-ablative laser therapy can improve the appearance of scalp hair in those with darker skin tones.

How Is the Trial Designed?

Group I: healthy subjects with moderate hair loss stage and skin color type 5 or 6 Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Lumenis Be Ltd.

Lead Sponsor

Trials

39

Recruited

1,500+

Published Research Related to This Trial

Combining laser treatments (like 308-nm excimer laser and He-Ne laser) with topical minoxidil significantly reduces the Severity of Alopecia Tool (SALT) score, indicating improved efficacy in treating alopecia areata compared to using minoxidil alone, based on a meta-analysis of 10 studies.

The combination therapy also results in a lower recurrence rate of hair loss after one year compared to minoxidil alone, while showing no significant increase in adverse events, suggesting it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser and light therapy combined with topical minoxidil for alopecia areata: a systematic review and meta-analysis of randomized controlled trials. Zhang, J., Lin, P., Lin, H., et al.[2023]

Citations

1. lumenis.com lumenis.com/aesthetics/products/folix/

FoLix: Laser System for Hair Loss FoLix is the first FDA-cleared fractional hair loss treatment. providing effective, safe, and simple treatment for women and men.

2. elysianheadspa.com elysianheadspa.com/blog/folix-laser-for-hair-restoration

FoLix Laser for Hair Restoration: Technology, Trials, and ... Expectation management: Results depend on the stage of hair loss, follicle viability, consistency of use, and individual biology. As with many ...

3. sierrarobotic.com sierrarobotic.com/folix-laser-hair-restoration-the-future-of-non-invasive-hair-restoration/

FoLix Laser Hair Restoration: The Future Of Non-Invasive ... Clinical studies validate the effectiveness of FoLix Laser Hair Restoration, showing remarkable outcomes such as: 10-18% increase in hair ...

4. meditresse.com meditresse.com/blog/prp-painless-hair-loss-therapy-proven-over-alma-ted-and-folix/

PRP therapy for hair loss versus Alma TED, and FoLix Studies so far have indicated a statistically significant increase in hair count, with an average 10% increase in hair density after treatment completion.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6554163/

Fractional Laser Modalities for the Treatment of Androgenic ... Generally, daily treatment for 12 weeks is needed before substantial results are seen, and once treatment is stopped hair loss will resume ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K242349.pdf

September 9, 2024 Lumenis Be Ltd. Shlomit Segman AVP, RA ... The FoLix Laser System, with wavelength of 1565 nm, is indicated for improving the appearance of scalp hair in adult males and females with.