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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types of LaserCaps to determine their effectiveness in promoting hair growth for individuals with male pattern baldness, also known as androgenetic alopecia. The study compares a sham (fake) LaserCap to two real ones, LaserCap HD+ and LaserCap SD, which have different energy levels, to assess if more energy results in more hair growth. It targets individuals with this type of hair loss who have not used other hair treatments in the past six months. Participants should exhibit specific patterns of baldness and have lighter skin tones. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for hair growth.

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 prior data suggests that these laser devices are safe for treating male pattern baldness?

Past studies have found low-level laser therapy (LLLT) devices like the LaserCap SD and HD+ to be safe and effective for treating hair loss in both men and women. These devices use laser light to stimulate hair growth without drugs or chemicals, reducing the risk of side effects. The LaserCap SD delivers a lower energy level, while the LaserCap HD+ provides a higher dose. Both devices are FDA-cleared, meeting safety standards for use. No major reports of harmful effects have emerged from using these laser caps, making them a promising option for those experiencing hair loss. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LaserCap HD+ and LaserCap SD because they offer a non-invasive, light-based approach to tackling male pattern baldness. Unlike traditional treatments like minoxidil or finasteride, which involve topical or oral medications, these LaserCaps use low-level laser therapy (LLLT) to stimulate hair growth. LaserCap HD+ delivers high fluence LLLT, while LaserCap SD provides a low fluence option, offering different intensity levels to potentially address varying degrees of hair loss. This innovative delivery method could provide a convenient, drug-free alternative for those seeking to rejuvenate their hair.

What evidence suggests that this trial's treatments could be effective for male pattern baldness?

Research has shown that low-level laser therapy (LLLT) can treat hair loss in both men and women. In this trial, participants may receive the LaserCap HD+, which uses a stronger energy level; studies suggest it may increase hair thickness. Alternatively, participants may receive the LaserCap SD, which uses less energy but remains safe and effective for treating hair loss. Both versions use light to stimulate hair follicles, potentially promoting hair growth. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8675345/

A Systematic Review and Meta-analysis of Randomized ... This systematic review and meta-analysis aimed to investigate the effectiveness of FDA-approved LLLT devices for PHL treatment.

2. lasercap.com lasercap.com/product/lasercap-hd-plus/?srsltid=AfmBOorTaRyh17RJZRSRfu0jUG_tdyk0F38-muxoE8u05A-K-fs5bDNa

LaserCap HD+ FDA-cleared laser therapy for male and female pattern hair loss. The LaserCap HD+ contains 304 laser diodes, delivering prescription-strength, 3.93 J/cm² dose ...

3. lasercap.com lasercap.com/does-laser-treatment-work-for-hair-loss/?srsltid=AfmBOoqBpHYlnopyNdfv6jWIkgOddQ_-dTUdsv6MwU-49ippPRrAbxWq

Does Laser Treatment Work for Hair Loss? Clinical studies have demonstrated that in many cases, in both men and women, LLLT slows, reverses, or stops hair loss. The evidence for LLLT efficacy is so ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05365360/sham-lasercap-vs-lasercap-sd-vs-lasercap-hd

Sham LaserCap vs. LaserCap SD vs. LaserCap HD+ These home-use, wearable devices utilize the ~650 nm wavelength laser light to stimulate the hair follicle mitochondria and thereby promote hair ...

5. innerbody.com innerbody.com/best-laser-cap-for-hair-loss

The Best Laser Caps for Hair Loss in 2025 Based on price, efficacy, comfort, and more, we help you find the best laser cap for your hair loss.

6. lasercap.com lasercap.com/product/lasercap-hd-plus/?srsltid=AfmBOor8OGxca3nx5xJ6stLTRWn2ZbOc943q8_QIrOhRd_gnqLBTyMaK

LaserCap HD+ FDA-cleared laser therapy for male and female pattern hair loss. The LaserCap HD+ contains 304 laser diodes, delivering prescription-strength, 3.93 J/cm² dose ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05365360

Study Details | NCT05365360 | Sham LaserCap vs. ... Accordingly, in the present study we aim to investigate if increasing fluence in LLLT devices is associated with increased hair density by comparing sham ...

8. sa1s3.patientpop.com sa1s3.patientpop.com/assets/docs/193420.pdf

Prescription-Strength Laser Therapy For Hair Regrowth The LaserCap is a 510k FDA-cleared, prescription-only, home use therapeutic device indicated to promote hair growth in men and women with Androgenic Alopecia,.