Laser Therapy for Male Pattern Baldness and Scarring Alopecia

Overseen By Anika Jallorina, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must not be taking: Minoxidil, 5-alpha reductase inhibitors

Disqualifiers: Alopecia areata, Immunosuppression, Diabetes, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6-8 weeks

10 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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 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.

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.

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?

Group I: Scarring Alopecia Experimental Treatment 1 Intervention

The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject to target scarring alopecia.

Group II: Androgenetic Alopecia Experimental Treatment 1 Intervention

The parameters of the laser will be set according to optimal operation protocol and in accordance with guidelines set forth by Sciton. Each laser treatment will take approximately 10 to 15 minutes per subject to target androgenetic alopecia.

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

Approved in United States as Sciton HALO for:

• Skin rejuvenation
• Fine lines and wrinkles
• Hyper-pigmentation
• Acne scars
• Enlarged pores
• Skin dullness
• Pigmented lesions

Approved in Canada as Sciton HALO for:

• Skin rejuvenation
• Fine lines and wrinkles
• Hyper-pigmentation
• Acne scars
• Enlarged pores
• Skin dullness
• Pigmented lesions

Approved in European Union as Sciton HALO for:

• Skin rejuvenation
• Fine lines and wrinkles
• Hyper-pigmentation
• Acne scars
• Enlarged pores
• Skin dullness
• Pigmented lesions

Approved in Japan as Sciton HALO for:

• Skin rejuvenation
• Fine lines and wrinkles
• Hyper-pigmentation
• Acne scars
• Enlarged pores
• Skin dullness
• Pigmented lesions

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy as a treatment for androgenetic alopecia. Afifi, L., Maranda, EL., Zarei, M., et al.[2022]

A pilot study involving males aged 20 to 60 with androgenic alopecia showed a statistically significant increase in hair growth after using the cold X5 hairlaser device over a 26-week period, with a strong p-value of 0.0003 indicating effectiveness.

The study demonstrated a consistent positive trend in hair counts over time, suggesting that the X5 hairlaser device may be a promising treatment for male pattern hair loss, although further research is needed due to some limitations in the control group data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Cold" X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study. Blum, K., Han, D., Madigan, MA., et al.[2021]

Laser technology has been effectively used for hair removal, but it can sometimes lead to paradoxical hypertrichosis, where hair growth unexpectedly increases in treated areas.

The review also highlights studies showing that laser and light therapies can promote hair regrowth in conditions like androgenetic alopecia and alopecia areata, suggesting potential biological mechanisms for hair regeneration through phototherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alopecia: a review of laser and light therapies. Rangwala, S., Rashid, RM.[2012]

A single treatment session with the 1,927 nm thulium fiber laser resulted in a 60-90% improvement in scalp photodamage, including dyspigmentation, solar lentigines, and keratosis in four male patients.

The procedure was safe, with no adverse events reported, indicating that this laser treatment is well-tolerated and effective for rejuvenating the male scalp.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rejuvenation of the male scalp using 1,927 nm non-ablative fractional thulium fiber laser. Boen, M., Wilson, MJV., Goldman, MP., et al.[2022]

Low-level laser therapy has been shown to be more effective than other nonsurgical treatments for androgenetic alopecia, with 47 devices receiving FDA premarket approval from 2000 to 2018.

The number of approved devices has increased since 2007, expanding treatment options for both men and women, although there are concerns about misleading marketing claims regarding their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shedding light on the FDA's 510(k) approvals process: low-level laser therapy devices used in the treatment of androgenetic alopecia. Wang, S., Seth, D., Ezaldein, H., et al.[2019]

In a 26-week double-blind study involving 110 male patients with androgenetic alopecia, the HairMax LaserComb significantly increased hair density compared to a sham device, indicating its effectiveness in promoting hair growth.

The HairMax LaserComb was well tolerated with no serious adverse events reported, suggesting it is a safe option for treating hair loss in males.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Leavitt, M., Charles, G., Heyman, E., et al.[2021]

In a study involving 17 participants (6 women and 11 men) with androgenetic alopecia, treatment with a 675 nm laser resulted in a significant increase in hair density and a reduction in hair miniaturization after 10 sessions.

The laser treatment was effective without any reported side effects, demonstrating a 60% reduction in the miniaturization process in the treated areas, indicating its potential as a safe and effective option for managing hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience of Novelty Laser Therapy Emission with 675 nm Wavelength for the Treatment of Androgenetic Alopecia in Male and Female Patients: A Case Series Study. Sorbellini, E., Fusco, I., Madeddu, F., et al.[2023]

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]

The RAMACAP helmet-type low-level laser therapy (LLLT) device significantly improved hair density and diameter in patients with androgenetic alopecia after 24 weeks of treatment, outperforming a sham device in a study of 40 participants.

The treatment was generally safe, with only minor side effects like temporary hair shedding and scalp itching reported, indicating that it could be a viable option for both men and women suffering from hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser therapy for the treatment of androgenetic alopecia in Thai men and women: a 24-week, randomized, double-blind, sham device-controlled trial. Suchonwanit, P., Chalermroj, N., Khunkhet, S.[2020]

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The goal of this clinical trial is to evaluate the effectiveness of a non-ablative 1470 nm laser in treating scarring alopecia in adults.

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Laser Therapy for Male Pattern Baldness and Scarring Alopecia

What data supports the effectiveness of the treatment Sciton HALO 1470nm Non-ablative laser for male pattern baldness and scarring alopecia? Research shows ...

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The study may enroll up to 10 participants looking for improvement in their hair loss. All participants will have biopsy-proven alopecia before enrollment.

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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 ...

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HALO 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 ...