Laser Therapy for Male Pattern Baldness and Scarring Alopecia

Overseen By Janet Choi, 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

Trial Summary

What is the purpose of this trial?

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

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

Research shows that low-level laser therapy (LLLT) is effective in promoting hair growth for androgenetic alopecia, with studies indicating increased hair density and diameter. Although specific data on the Sciton HALO 1470nm laser is not available, similar laser therapies have shown positive results in hair regrowth. ^{1 2 3 4 5}

Is laser therapy safe for treating hair loss conditions?

Based on available studies, laser therapy, including devices like the HairMax LaserComb and other laser treatments, appears to be generally safe for treating hair loss conditions like androgenetic alopecia, with no significant difference in adverse events compared to other treatments. ^{6 7 8 9 10}

How does the Sciton HALO 1470nm Non-ablative laser treatment differ from other treatments for male pattern baldness?

The Sciton HALO 1470nm Non-ablative laser is unique because it uses a specific wavelength of 1470 nm, which is different from the commonly used wavelengths like 655 nm or 675 nm in other laser therapies for hair loss. This non-ablative approach means it targets deeper layers of the skin without damaging the surface, potentially offering a novel mechanism for stimulating hair growth. ^{1 4 8 10 11}

Research Team

Kseniya Kobets, MD

Principal Investigator

Albert Einstein College of Medicine Montefiore Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2019]

2. England 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. [2020]

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

A review of monochromatic light devices for the treatment of alopecia areata. [2018]

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

Low-level laser therapy as a treatment for androgenetic alopecia. [2022]

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

Rejuvenation of the male scalp using 1,927 nm non-ablative fractional thulium fiber laser. [2022]

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

Alopecia: a review of laser and light therapies. [2012]

7. 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]

8. New Zealand 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. [2021]

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

Laser hair reduction in the hirsute patient: a critical assessment. [2019]

10. United States 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. [2023]

11. England pubmed.ncbi.nlm.nih.gov

"Cold" X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study. [2021]