Non-Ablative Laser for Scarring Alopecia

Overseen By Anika Jallorina, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must not be taking: Immunosuppressives, Retinoids

Disqualifiers: Pregnancy, Immunosuppression, Recent surgery, others

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

Compensation: Varies

Number of Visits: 8

Duration: 3 months

5 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial requires that you do not start any new medications for hair loss, like minoxidil, during the study. However, it does not specify if you need to stop other current medications, but you must have a stable hair loss treatment regimen for at least 3 months before joining.

What data supports the effectiveness of this treatment for scarring alopecia?

Research shows that non-ablative fractional lasers have been effective in improving hair regrowth and density in conditions like male and female pattern hair loss. This suggests that similar laser treatments might help with scarring alopecia by enhancing hair follicle regeneration. ^{1 2 3 4 5}

Is the 1470nm non-ablative fractional laser safe for humans?

Research on similar non-ablative fractional lasers, like the 1550-nm laser, shows they are generally safe for treating scars, with some mild side effects like redness and swelling. ^{6 7 8 9 10}

How does the 1470nm non-ablative fractional laser treatment for scarring alopecia differ from other treatments?

The 1470nm non-ablative fractional laser treatment is unique because it uses a specific wavelength of light to target and improve scarring without damaging the skin's surface, unlike ablative lasers that remove layers of skin. This approach is less invasive and may have fewer side effects compared to traditional methods. ^{2 7 9 11 12}

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults. The study will also investigate the biochemical molecular pathways involved in laser therapy by analyzing hair follicle gene expression before and after laser treatment. The main questions it aims to answer are: 1. Does a non-ablative laser work to effectively treat scarring alopecia? 2. What molecular pathways are associated with the laser's effects on hair follicles in scarring alopecia? Participants with scarring alopecia will: * Receive 3 laser treatments, spaced 1 month apart (Month 1, Month 2, Month 3), and attend 5 follow-up visits (Month 4, Month 6, Month 9, Month 12 and Month 15) * Have hair follicle samples collected via hair plucking of 10 hairs prior to the start and 1-month post-completion of laser treatments for gene expression analysis of inflammatory and fibrosis pathways implicated in scarring alopecia. Hair samples will be de-identified and kept anonymous. * Fill out questionnaires at each visit * Keep a diary of any side effects from laser treatments

Research Team

Kseniya Kobets, MD

Principal Investigator

Albert Einstein College of Medicine Montefiore Medical Center

Eligibility Criteria

This trial is for adults with scarring alopecia, a condition where scar tissue replaces hair follicles leading to permanent hair loss. Participants must be willing to undergo three laser treatments and attend follow-up visits. They should also agree to provide hair samples for analysis.

Inclusion Criteria

Subject must voluntarily sign and date an IRB approved informed consent form

Subject is determined to be healthy, non-smoker who agrees not to make any changes to their daily hair treatment regime during the study

Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period

Exclusion Criteria

No ethnic or racial group restrictions

I do not have permanent hair loss due to scarring.

Pregnant Women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 laser treatments, spaced 1 month apart, using the non-ablative Sciton HALO laser (1470nm) for scarring alopecia

3 months

3 visits (in-person)

Follow-up

Participants attend follow-up visits for clinical assessments, including hair density evaluation and gene expression analysis

12 months

5 visits (in-person)

Treatment Details

Interventions

• 1470nm non-ablative fractional laser

Trial Overview The trial tests if a 1470nm non-ablative fractional laser can effectively treat scarring alopecia and aims to understand the molecular pathways affected by this treatment through gene expression analysis in hair follicle samples before and after therapy.

Participant Groups

Group I: Scarring alopecia Experimental Treatment 1 Intervention

Patients with scarring alopecia will receive 3 treatments with the non-ablative Sciton HALO laser (1470nm). Each laser treatment will take approximately 10 to 15 minutes per subject.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Sciton

Industry Sponsor

Trials

20

Recruited

1,400+

American Society for Laser Surgery and Medicine

Collaborator

Trials

1

Recruited

6+

References

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

Therapeutic efficacy and safety of a 1927-nm fractionated thulium laser on pattern hair loss: an evaluator-blinded, split-scalp study. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Lux1540nm fractional laser treatment for superficial scar]. [2013]

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

Enhancing hair follicle regeneration by nonablative fractional laser: Assessment of irradiation parameters and tissue response. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Fractional non-ablative laser-assisted drug delivery leads to improvement in male and female pattern hair loss. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical effects of non-ablative and ablative fractional lasers on various hair disorders: a case series of 17 patients. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Application of fractional laser resurfacing in the treatment of superficial scar]. [2010]

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

Comparison of non-ablative and ablative fractional laser treatments in a postoperative scar study. [2022]

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

Successful treatment of atrophic postoperative and traumatic scarring with carbon dioxide ablative fractional resurfacing: quantitative volumetric scar improvement. [2022]

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

Efficacy and safety of 1550-nm fractional laser in the treatment of acne scars in Chinese patients: A split-face comparative study. [2022]

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

A 2940 nm fractional photothermolysis laser in the treatment of acne scarring: a pilot study in China. [2009]

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

Comparison of 1565-nm Nonablative Fractional Laser and 10600-nm Ablative Fractional Laser in the Treatment of Mild to Moderate Atrophic Acne Scars. [2021]

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

Treatment of surgical scars with nonablative fractional laser versus pulsed dye laser: a randomized controlled trial. [2022]