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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a 1470nm non-ablative fractional laser can effectively treat scarring alopecia, a condition where scarring causes permanent hair loss. Researchers seek to understand the laser's effects on hair follicles at a molecular level by examining changes before and after treatment. Participants will receive three laser treatments, and hair samples will be taken to analyze these changes. Individuals diagnosed with scarring alopecia, who have experienced stable hair loss for at least three months, and who do not plan to change their hair treatment routine may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for scarring alopecia.

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 prior data suggests that this non-ablative laser is safe for treating scarring alopecia?

Research has shown that the 1470 nm non-ablative laser is generally safe for people. In past studies, this laser treated conditions like acne scars and proved to be safe and well-tolerated, with no major side effects reported.

For conditions similar to scarring alopecia, such as androgenetic alopecia, the 1470 nm laser was also tested and found to be safe. Patients did not experience significant side effects during these tests. This suggests that the laser treatment might also be safe for people with scarring alopecia.

In summary, past studies indicate that this laser treatment is usually safe and easy for people to handle. Participants didn't report serious side effects, which is encouraging for those considering joining a clinical trial for scarring alopecia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 1470nm non-ablative fractional laser for scarring alopecia because it offers a unique approach compared to standard treatments like corticosteroids and immunosuppressants. This laser treatment works by gently resurfacing the skin without removing layers, which could potentially stimulate hair regrowth and improve scalp health. Unlike more invasive procedures, this method involves minimal downtime and discomfort, making it a promising option for those seeking less aggressive treatment for scarring alopecia.

What evidence suggests that this laser treatment might be effective for scarring alopecia?

Research has shown that certain lasers, such as non-ablative fractional lasers, may help treat hair loss conditions like male and female pattern baldness. In this trial, participants with scarring alopecia will receive treatments with the 1470 nm non-ablative fractional laser. Although limited data from human studies exist specifically for scarring alopecia, these lasers target affected hair follicles and might reduce inflammation and scarring. The 1470 nm laser delivers energy to the skin without damaging the surface, potentially aiding hair regrowth. Early findings suggest this method might increase hair thickness and coverage. More research is needed to confirm these effects specifically for scarring alopecia, but initial results appear promising. ^{2 6 7 8 9}

Who Is on the Research Team?

Kseniya Kobets, MD

Principal Investigator

Albert Einstein College of Medicine Montefiore Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06946550

Non-Ablative Laser to Treat Scarring Alopecia With Hair ... The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06946550/non-ablative-laser-to-treat-scarring-alopecia-with-hair-follicle-gene-expression-analysis

Non-Ablative Laser to Treat Scarring Alopecia With Hair ... The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05460611?term=androgenetic%20alopecia&viewType=Table&rank=9

1470nm Laser for the Treatment of Androgenetic Alopecia ... Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and ...

4. withpower.com withpower.com/trial/non-ablative-laser-for-scarring-alopecia-8d537

Non-Ablative Laser 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 ...

5. trialx.com trialx.com/clinical-trials/listings/249870/1470nm-laser-for-the-treatment-of-androgenetic-alopecia-and-scarring-alopecia/

1470nm Laser for the Treatment of Androgenetic Alopecia ... The study may enroll up to 10 participants looking for improvement in their hair loss. All participants will have biopsy-proven alopecia before ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06946550

Non-Ablative Laser to Treat Scarring Alopecia With Hair ... The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults.

7. trialx.com trialx.com/clinical-trials/listings/310245/non-ablative-laser-to-treat-scarring-alopecia-with-hair-follicle-gene-expression-analysis/

Non-Ablative Laser to Treat Scarring Alopecia With Hair ... 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11911818/

Effectiveness and Safety of the Use of 1470 nm Laser Therapy ... The 1470 nm non-ablative laser therapy demonstrated high efficacy and safety in the treatment of acne scars, delivering substantial therapeutic benefits and ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05460611/1470nm-laser-for-the-treatment-of-androgenetic-alopecia-and-scarring-alopecia

1470nm Laser for the Treatment of Androgenetic Alopecia ... Single-center, open-label, baseline-controlled, pilot study evaluating the use of a Nonablative 1470 nm laser for the treatment of androgenetic alopecia and ...