10 Participants Needed

Laser Therapy for Male Pattern Baldness and Scarring Alopecia

EB
HK
JC
AJ
Overseen ByAnika Jallorina, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser treatment to address hair loss from male pattern baldness or scarring. It focuses on using the Sciton HALO 1470nm laser for these conditions. The trial seeks healthy adults who have experienced hair loss for at least six months and maintain a stable hair loss treatment plan. Participants must be non-smokers and agree not to change their hair care routine during the study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research in hair loss treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using minoxidil or 5-alpha reductase inhibitors (like finasteride or dutasteride) at least 3 months before joining. You also cannot have used immunosuppressive medications, Accutane, or other systemic retinoids in the past 6 to 12 months.

What prior data suggests that this laser therapy is safe for treating alopecia?

Research has shown that the Sciton HALO 1470nm Non-ablative laser is being tested for treating hair loss conditions like male pattern baldness and scarring alopecia. Although specific safety data for these conditions is not yet available, HALO lasers are known for being non-ablative, meaning they don't remove any layers of skin. This characteristic usually suggests the treatment is likely to be well-tolerated.

The laser employs different wavelengths to address skin issues and is already used for various skin treatments, often with minimal side effects. However, as this is an early study, detailed safety data remains limited. The non-ablative nature of the laser suggests it could be safe. Participants in these studies should always report any side effects to their doctors.12345

Why are researchers excited about this trial?

Researchers are excited about the Sciton HALO 1470nm Non-ablative laser for male pattern baldness and scarring alopecia because it offers a new approach compared to traditional treatments like medications and hair transplants. This laser treatment targets hair loss with precision by using a specific wavelength (1470nm) that can penetrate the scalp without damaging the surface, potentially stimulating hair growth and improving scalp health. The quick treatment time of just 10 to 15 minutes per session is another advantage, making it a convenient option for patients. Furthermore, this non-invasive laser therapy could reduce the risk of side effects associated with more invasive procedures, making it a promising alternative for those seeking effective hair restoration solutions.

What evidence suggests that the Sciton HALO 1470nm Non-ablative laser is effective for treating androgenetic and scarring alopecia?

Research has shown that the Sciton HALO 1470nm laser could help with male pattern baldness and hair loss due to scarring. In this trial, participants will be divided into two groups: one targeting androgenetic alopecia (male pattern baldness) and the other targeting scarring alopecia. For male pattern baldness, studies suggest that this laser might increase hair thickness and growth by stimulating hair follicles without harming the skin's surface. For hair loss from scarring, early research indicates that the laser can reduce scars and encourage hair to grow back by reaching deeper skin layers. The laser uses specific light wavelengths to promote healing and hair growth while keeping recovery time short. Although more research is needed, these early results are promising for people dealing with hair loss and scarring.12356

Who Is on the Research Team?

KK

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 healthy adults over 18 with a confirmed diagnosis of androgenetic alopecia or scarring alopecia, who have experienced hair loss in the last 6 months. Participants must not smoke, should agree to maintain their current hair care routine without changes, and cannot have used certain hair loss treatments recently.

Inclusion Criteria

Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period
I am 18 or older and looking for treatment for hair loss.
I am over 18 and looking for treatment for hair loss.
See 8 more

Exclusion Criteria

I haven't taken immunosuppressive drugs in the last 6 months.
I have a history of major depression or thyroid problems.
I have not had steroid injections in my scalp in the past year.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive up to three 1470nm laser treatments for androgenetic and scarring alopecia

6-8 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinical assessments and hair density evaluations

15 months
4 visits (in-person) at months 6, 9, 12, and 15

What Are the Treatments Tested in This Trial?

Interventions

  • Sciton HALO 1470nm Non-ablative laser
Trial Overview The study tests a non-ablative 1470 nm laser (Sciton HALO) on individuals with specific types of hair loss. It's an open-label pilot study where all participants receive the same treatment to see if it improves their condition.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Scarring AlopeciaExperimental Treatment1 Intervention
Group II: Androgenetic AlopeciaExperimental Treatment1 Intervention

Sciton HALO 1470nm Non-ablative laser is already approved in United States, Canada, European Union, Japan for the following indications:

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Approved in United States as Sciton HALO for:
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Approved in Canada as Sciton HALO for:
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Approved in European Union as Sciton HALO for:
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Approved in Japan as Sciton HALO for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials
468
Recruited
599,000+

Sciton

Industry Sponsor

Trials
20
Recruited
1,400+

Published Research Related to This Trial

Laser hair removal is effective for treating hirsutism, particularly in women with lighter skin and darker hair, but it is not considered a permanent solution, requiring repeated treatments for optimal results.
Different laser types, such as ruby, alexandrite, and diode lasers, show similar success rates, while the neodymium:Yttrium-Aluminum-Garnet (nd:YAG) laser is less effective; however, more extensive studies are needed to determine the long-term benefits and optimal treatment protocols.
Laser hair reduction in the hirsute patient: a critical assessment.Sanchez, LA., Perez, M., Azziz, R.[2019]
The 308-nm excimer laser has been shown to be a safe and effective treatment for hair regrowth in patients with alopecia areata, supported by evidence from eight clinical trials and two case reports involving men, women, and children.
While low-level laser therapy (LLLT) and fractional laser therapy showed some promise in individual cases, more research is needed to establish their efficacy compared to standard treatments for alopecia areata.
A review of monochromatic light devices for the treatment of alopecia areata.Darwin, E., Arora, H., Hirt, PA., et al.[2018]
A systematic review of 11 studies involving 680 patients showed that low-level laser therapy (LLLT) significantly improved hair count and density in both males and females with androgenetic alopecia (AGA).
Patient satisfaction with LLLT was generally positive, indicating that it may be a promising alternative treatment for AGA, especially for those who prefer not to use medication or undergo surgery.
Low-level laser therapy as a treatment for androgenetic alopecia.Afifi, L., Maranda, EL., Zarei, M., et al.[2022]

Citations

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 ...
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.
Laser Therapy for Male Pattern Baldness and Scarring AlopeciaWhat data supports the effectiveness of the treatment Sciton HALO 1470nm Non-ablative laser for male pattern baldness and scarring alopecia? Research shows ...
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 enrollment.
HALO, The World's First Hybrid Fractional Laser (HFL)The world's first and only hybrid fractional laser, applying tunable non-ablative and ablative wavelengths in a single pass to maximize results and reduce ...
6.sciton.comsciton.com/halo/
HALO® Laser by ScitonHALO combines ablative and non-ablative wavelengths to address multiple levels of skin concerns on all skin types in 1-2 treatments. Halo device being used on ...
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