Laser Therapy for Male Pattern Baldness and Scarring Alopecia
Recruiting in Palo Alto (17 mi)
Overseen ByKseniya Kobets, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Montefiore Medical Center
No Placebo Group
Approved in 5 jurisdictions
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.
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.
245811Is 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.
1231011What 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.
56789Will 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.
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
I have been diagnosed with a type of hair loss due to genetics or scarring in the last 6 months.
Exclusion Criteria
I haven't taken immunosuppressive drugs in the last 6 months.
I haven't had surgery in the treatment area in the last year or any major surgery in the last 6 months.
I have a history of high cholesterol, diabetes, hepatitis, or bleeding disorders.
I have a type of hair loss condition affecting my scalp.
I am unable to give consent for the study on my own.
I have not had chemotherapy in the last 12 months and do not have an immune deficiency.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Scarring AlopeciaExperimental Treatment1 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 AlopeciaExperimental Treatment1 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, Australia, 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 Australia 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Montefiore Einstein Advanced CareElmsford, NY
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Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
ScitonIndustry Sponsor
References
Laser hair reduction in the hirsute patient: a critical assessment. [2019]Hirsutism affects 5-10% of unselected women, depending on ethnicity and definition. The past two decades have seen the development of lasers for the removal of unwanted hair, using selective destruction of the hair follicle without damage to adjacent tissues. Selective photothermolysis relies on the absorption of a brief radiation pulse by specific pigmented targets, which generates and confines the heat to that selected target. In general, laser hair removal is most successful in patients with lighter skin colours and dark coloured hairs. Some studies have documented the results of laser hair removal in a controlled setting, although few have extended their observations beyond 1 year. In general, treatment with the ruby, alexandrite or diode lasers, or the use of intense pulsed light results in similar success rates, although these are somewhat lower for the neodymium:Yttrium-Aluminum-Garnet (nd:YAG) laser. Overall, laser hair removal should not be considered 'permanent', at least when considering the current data available. Repeated therapies are necessary, although complete alopoecia is rarely achieved and it is unclear at what point the maximum benefit is achieved from multiple therapies. While larger prospective, controlled, blinded and uniform studies are still needed, laser hair removal appears to be a useful adjuvant in the treatment of the hirsute patient.
HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. [2021]The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user's hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA).
Alopecia: a review of laser and light therapies. [2012]Since the 1980s, laser technology has become increasingly popular to treat a variety of cutaneous conditions. Its successful use as an epilator comes with the rare but interesting side effect of paradoxical hypertrichosis. In this review, we summarize cases describing hair growth after photoepilation, as well as studies testing laser and light sources as treatment for alopecia, particularly androgenetic alopecia and alopecia areata. We also discuss the possible biologic mechanisms by which phototherapy induces hair regeneration.
"Cold" X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study. [2021]Various trials have been conducted on the management and treatment of androgenic alopecia (AGA) or male pattern hair loss using a variety of laser and light sources.
Low-level laser therapy as a treatment for androgenetic alopecia. [2022]Androgenetic alopecia (AGA) affects 50% of males by age 50 and 50% of females by age 80. Recently, the use of low-level laser therapy (LLLT) has been proposed as a treatment for hair loss and to stimulate hair regrowth in AGA. This paper aims to review the existing research studies to determine whether LLLT is an effective therapy for AGA based on objective measurements and patient satisfaction.
Rejuvenation of the male scalp using 1,927 nm non-ablative fractional thulium fiber laser. [2022]The male scalp undergoes extensive photodamage due to a high prevalence of androgenic alopecia and exposure to ultraviolet radiation. This photodamage presents as solar lentigines, fine rhytides, and keratosis, and can prematurely age a patient. In this study, we demonstrate the safety and efficacy of the fractionated 1,927 nm thulium fiber laser using high density and high energy settings to achieve rejuvenation of the male scalp after a single treatment session.
A review of monochromatic light devices for the treatment of alopecia areata. [2018]There are many laser technologies that are being tested that claim to support hair regrowth for patients with alopecia areata (AA). In this paper, we will determine whether the body of evidence supports the use of devices using monochromatic light sources to treat AA. Articles were gathered from PubMed, Embase, and the Cochrane database using these keywords: lasers, excimer laser, low-level laser therapy (LLLT), low-level light therapy, alopecia, alopecia areata, and hair loss with a category modifier of English. Ten clinical trials and seven case reports/abstracts were assessed. Eight clinical trials and two case reports demonstrated hair regrowth with the 308-nm excimer laser/light in men, women, and children. One case report demonstrated hair regrowth with the ALBA 355® laser. One clinical trial and two case reports demonstrated hair regrowth with LLLT. While two case reports demonstrated hair regrowth with fractional laser therapy, one clinical trial showed no improvement. The 308-nm excimer laser is a safe and effective treatment for men, women, and children with refractory AA of the scalp and beard. Larger, double-blinded clinical trials should be conducted to compare excimer laser therapy to standard treatments. More data is needed to determine the efficacy of LLLT and fractional laser therapy in the treatment of AA.
Shedding light on the FDA's 510(k) approvals process: low-level laser therapy devices used in the treatment of androgenetic alopecia. [2019]Introduction: Low-level laser therapy has demonstrated superior efficacy relative to other nonsurgical treatment options for the treatment of androgenetic alopecia. Methods: Records from a public U.S. FDA database for premarket approval of low-level laser therapy devices approved between January 1 2000 and July 15 2018 were reviewed. Results: 47 devices received 510(k) premarket approval, with an increasing number of devices available since 2007. More options are now available and product indications have expanded for use in a wider audience, including both men and women. Discussion: Growing recognition of lasers has led to an increasing number of devices available as well as innovative options in terms of design and convenience. In the past few years, these devices have adopted broader indications for use in both men and women. However, marketed indications have not been adequately explored and current devices on the market have the potential to mislead consumers.
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]Low-level laser/light therapy (LLLT) has been increasingly used for promoting hair growth in androgenetic alopecia (AGA). Our institute developed a new home-use LLLT device, RAMACAP, with optimal penetrating energy, aiming to improve therapeutic efficacy and compliance. To evaluate the efficacy and safety of the new helmet-type LLLT device in the treatment of AGA, a 24-week, prospective, randomized, double-blind, sham device-controlled clinical trial was conducted. Forty subjects with AGA (20 men and 20 women) were randomized to treat with a laser helmet (RAMACAP) or a sham helmet in the home-based setting for 24 weeks. Hair density, hair diameter, and adverse events were evaluated at baseline and at weeks 8, 16, and 24. Global photographic assessment for hair regrowth after 24 weeks of treatment was performed by investigators and subjects. Thirty-six subjects (19 in the laser group and 17 in the sham group) completed the study. At week 24, the laser helmet was significantly superior to the sham device for increasing hair density and hair diameter (p = 0.002 and p = 0.009, respectively) and showed a significantly greater improvement in global photographic assessment by investigators and subjects. Reported side effects included temporary hair shedding and scalp pruritus. In conclusion, the novel helmet-type LLLT device appears to be an effective treatment option for AGA in both male and female patients with minimal adverse effects. However, the limitations of this study are small sample size, no long-term follow-up data, and use of inappropriate sham devices, which do not reflect the true negative control. Trial registration: http://clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=2061 , identifier TCTR20160910003.
Laser and light therapy combined with topical minoxidil for alopecia areata: a systematic review and meta-analysis of randomized controlled trials. [2023]We aim to evaluate the clinical efficacy and safety of using laser and light combined with topical minoxidil for alopecia areata. We searched PubMed, Embase, Web of Science, the Cochrane Library, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), VIP database, and Wanfang Data from their inception to September 18, 2022. The risk of bias of the included RCTs was assessed by the Cochrane Collaboration tool. RevMan 5.3 software and Stata 14.0 software were used to perform the statistical analysis. The GRADE system assessed the quality of evidence. Ten studies were enrolled finally. The results of the meta-analysis showed that compared with topical minoxidil alone, the 308-nm excimer laser/light or He-Ne laser combined with topical minoxidil could reduce the SALT (Severity of Alopecia Tool) score (MD= -5.88, 95% CI [-9.79, -1.98], P=0.003). Whether fractional CO2 laser (RR=1.29, 95% CI [1.14, 1.46], P<0.0001), 308-nm excimer laser/light (RR=1.32, 95% CI [1.12, 1.55], P=0.001), He-Ne laser (RR=1.69, 95% CI [1.07, 2.69], P=0.03), or NB-UVB (RR=1.35, 95% CI [1.07,1.70], P=0.01) combined with topical minoxidil may improve the treatment response rate, comparing with topical minoxidil only. The recurrence rate of laser and light combined with topical minoxidil was lower than that of the minoxidil alone group (RR=0.54, 95% CI [0.31, 0.93], P=0.03) when follow-up time was 1 year. In addition, the incidence of adverse events including irritant contact dermatitis, erythema, desquamation, pain, and pruritus was no significant difference between the two groups (RR=1.50, 95% CI [0.95, 2.36], P=0.08). The level of evidence for outcomes was classified as very low to moderate. Based on the available evidence, laser and light combined with topical minoxidil therapy may be effective and safe for alopecia areata. However, more high-quality trials are required for comprehensive analysis and further verification.
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]Background: Alopecia androgenetica is the most common type of hair loss. It is estimated that 60-70% of the world's population is affected, with men having a slight advantage. This condition supports a progressive hair thinning in androgen-sensitive zones, as defined by the Hamilton and Norwood classifications for men and Ludwig classifications for women. There are numerous published studies that show the effect of red light (650-675 nm) on hair growth biostimulation. Objective: To validate this correlation, the aim of this study was to assess the efficacy of 675 nm laser emission for the management of alopecia androgenetica in female and male subjects. Methods: A total of 17 subjects (6 women and 11 men) aged from 18 to 65 years, without other comorbidities, with an alopecia androgenetica grade ranges between I-II in women (according to Ludvig scale) and I-II-III in men (according to Hamilton scale) were enrolled in the study between October and December 2021. All patients underwent 10 sessions of 675 nm laser treatment, each lasting 20 min, without the use of concomitant systemic or topical therapies. Results: The results verified at epiluminescence stage, and at the third month of follow-up and at the end of treatment, showed a significant increase in the density of the hair shafts and a reduction of yellow dots and telangiectasias characteristic of alopecia androgenetica. Conclusions: The 675 nm laser showed excellent outcomes resulting in a 60% reduction of the miniaturization process in the treated areas without side effect.