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

Trial Summary

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.

Is laser treatment for alopecia safe?

Research suggests that laser treatments, like the 308-nm excimer laser, are generally safe for treating alopecia, with mild or few side effects reported. A study on the nonablative Er:YAG laser also showed no adverse effects, indicating good safety in humans. ^{1 2 3 4 5}

How does the FoLix treatment differ from other treatments for alopecia?

The FoLix treatment is unique because it involves laser technology to enhance the delivery of antialopecia drugs directly into the skin and hair follicles, potentially increasing their effectiveness. This approach is minimally invasive and may improve patient compliance compared to traditional treatments. ^{1 6 7 8 9}

What is the purpose of this trial?

The study incudes 18 to 55 y/o healthy subjects with moderate hair loss stage and Fitzpatrick skin type 5 or 6

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Hair regrowth and maintenance in alopecia universalis patient treated with nonablative Er:YAG laser. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Influence Factors of 308-nm Excimer Lamp with Minoxidil in the Treatment of Alopecia Areata. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Meta-analysis of 308-nm excimer laser therapy for alopecia areata. [2021]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Differences in reproductive toxicology between alopecia drugs: an analysis on adverse events among female and male cases. [2022]

6. India pubmed.ncbi.nlm.nih.gov

308-nm Excimer Lamp for the Treatment of Alopecia Areata: Clinical Trial on 16 Cases. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Erbium-yttrium-aluminum-garnet laser irradiation ameliorates skin permeation and follicular delivery of antialopecia drugs. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

The Use of a 1,540 nm Fractional Erbium-Glass Laser in Treatment of Alopecia Areata. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Association of khellin and 308-nm excimer lamp in the treatment of severe alopecia areata in a child. [2018]