LaserCaps for Male Pattern Baldness

Overseen By Patrick Jedlowski, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Must not be taking: Minoxidil, Finasteride, Dutasteride

Disqualifiers: Norwood Va-VII, Ludwig III, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any current treatments for male pattern baldness, such as minoxidil or finasteride, for at least six months before joining the trial.

What data supports the effectiveness of the treatment LaserCaps for Male Pattern Baldness?

Research shows that low-level laser therapy (LLLT), used in devices like LaserCaps, can effectively promote hair growth in people with androgenetic alopecia (a common form of hair loss). Studies indicate that LLLT can increase hair density and diameter, with nearly 80% of users experiencing positive results. ^{1 2 3 4 5}

Is LaserCap safe for treating male pattern baldness?

Research shows that low-level laser therapy (LLLT), used in devices like LaserCaps, is generally safe for treating hair loss. Some studies report minimal side effects such as temporary hair shedding and scalp itching. ^{1 2 3 4 6}

How does the LaserCap treatment for male pattern baldness differ from other treatments?

The LaserCap treatment uses low-level laser therapy (LLLT), which is a non-invasive method that promotes hair growth by using visible red light to stimulate hair follicles, unlike traditional drug treatments like minoxidil or finasteride. This therapy is unique because it offers a non-drug alternative with minimal side effects, and it can be used at home, providing convenience and ease of use. ^{1 2 3 4 7}

What is the purpose of this trial?

Androgenetic alopecia (AGA) is a prevalent disease, occurring in 80% of Caucasian men and 50% of Caucasian women by age 701. Treatments for AGA are limited, and presently the only FDA-approved medications for AGA are topical minoxidil and oral finasteride1. In addition to medical therapies, FDA-cleared medical devices are now utilized for the treatment of AGA as of 20072. These devices, termed low level laser therapy (LLLT), come in multiple forms including combs, helmets and sports cap wearable devices2. These home-use, wearable devices utilize the \~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair growth, a process termed "photobiomodulation"3. Recent meta-analyses investigating photobiomodulation and LLLT for AGA have noted an increase in fluence or energy delivered per cm is associated with increased hair density3. However, randomized control trials (RCT) with direct comparison of LLLT devices of different fluences has yet to be performed. Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham LaserCap to LaserCap SD (1.15 J/cm2, low fluence) and LaserCap HD+ (3.93 J/cm2, high fluence) in RCT.

Eligibility Criteria

This trial is for men and women aged 25 or older with Androgenetic Alopecia (commonly known as male pattern baldness), who haven't treated it recently, or have stopped previous treatments for at least 6 months. Men should be in the early to moderate stages of hair loss, while women can also join if they're experiencing certain patterns of thinning. Participants must have skin types I to IV according to the Fitzpatrick scale.

Inclusion Criteria

I am 25 years old or older.

I am a woman with mild to moderate hair loss, not currently treated or past treatments stopped 6 months ago.

All patients with AGA: Fitzpatrick skin types I to IV

Exclusion Criteria

I am a woman with advanced stage hair loss.

I am a man with advanced hair loss.

All patients with AGA: Fitzpatrick skin types V, VI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low level laser therapy (LLLT) using either a sham LaserCap, LaserCap SD, or LaserCap HD+ to assess the effect of increasing fluence on hair density

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LaserCap HD+
• LaserCap SD
• Sham LaserCap

Trial Overview The study tests three different scalp treatments using laser caps: a fake 'Sham' LaserCap that doesn't emit real lasers, a 'LaserCap SD' with low energy emission, and a 'LaserCap HD+' with high energy emission. The goal is to see if higher energy levels from these caps can increase hair density more effectively than lower levels or no treatment.

Participant Groups

Group I: Lasercap SD Experimental Treatment 1 Intervention

Low fluence LLLT

Group II: Lasercap HD+ Experimental Treatment 1 Intervention

High fluence LLLT

Group III: Sham LaserCap Placebo Group 1 Intervention

Sham device

LaserCap HD+ is already approved in United States for the following indications:

Approved in United States as LaserCap HD+ for:

• Androgenetic Alopecia (Male Pattern Hair Loss)
• Androgenetic Alopecia (Female Pattern Hair Loss)

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Transdermal Cap, Inc.

Industry Sponsor

Trials

1

Recruited

50+

Findings from Research

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]

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]

Low level laser therapy (LLLT) using a device with 21 lasers and 30 LEDs significantly increased hair counts in males with androgenetic alopecia, showing a 39% increase compared to the placebo group after 16 weeks of treatment.

The study involved 44 males aged 18-48, and no adverse events or side effects were reported, indicating that LLLT is a safe option for promoting hair growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The growth of human scalp hair mediated by visible red light laser and LED sources in males. Lanzafame, RJ., Blanche, RR., Bodian, AB., et al.[2022]

Low-level laser therapy (LLLT) has been shown to effectively stimulate hair growth in both men and women, with evidence from controlled clinical trials and studies on mice with chemotherapy-induced alopecia.

The proposed mechanism of action for LLLT involves the stimulation of epidermal stem cells in hair follicles, promoting the transition of hair follicles into the growth phase (anagen), making it a promising treatment option for alopecia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-level laser (light) therapy (LLLT) for treatment of hair loss. Avci, P., Gupta, GK., Clark, J., et al.[2022]

A study involving 1383 patients using an FDA-cleared low-level laser helmet for androgenetic alopecia (AGA) showed an overall clinical effectiveness of nearly 80%, with recommended treatment duration being over 1 year or more than 180 uses.

Factors influencing treatment efficacy included being male, using the device for longer periods, and having scalp conditions like dandruff, rash, or itchiness, which were associated with better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy assessment for low-level laser therapy in the treatment of androgenetic alopecia: a real-world study on 1383 patients. Qiu, J., Yi, Y., Jiang, L., et al.[2022]

Photobiomodulation, or low-level laser therapy, is a safe and potentially effective treatment for hair loss, supported by several randomized trials.

Devices for this therapy, such as LED caps or helmets, are user-friendly and can be used at home, although there are limitations like cost and the need for managing patient expectations regarding results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation for the management of hair loss. Torres, AE., Lim, HW.[2021]

In a case study of four patients with lichen planopilaris (LPP), low-level light therapy (LLLT) resulted in significant improvements, including reduced inflammation, symptom relief, and noticeable hair regrowth without any side effects.

While traditional treatments for LPP mainly involve steroids and hydroxychloroquine, this report suggests that LLLT could be a promising alternative therapy for managing LPP and similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lichen Planopilaris and Low-Level Light Therapy: Four Case Reports and Review of the Literature About Low-Level Light Therapy and Lichenoid Dermatosis. Randolph, MJ., Salhi, WA., Tosti, A.[2020]

References

1. 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]

2. 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]

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

The growth of human scalp hair mediated by visible red light laser and LED sources in males. [2022]

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

Low-level laser (light) therapy (LLLT) for treatment of hair loss. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy assessment for low-level laser therapy in the treatment of androgenetic alopecia: a real-world study on 1383 patients. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation for the management of hair loss. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Lichen Planopilaris and Low-Level Light Therapy: Four Case Reports and Review of the Literature About Low-Level Light Therapy and Lichenoid Dermatosis. [2020]