Low Level Laser Therapy for Male Pattern Baldness

Not currently recruiting at 1 trial location
CA
Overseen ByCharlotte Antoni Clinical Research Coordinator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Ultra to determine its effectiveness in regrowing hair in men with male pattern baldness. Researchers aim to assess the device's safety and effectiveness by measuring changes in hair thickness and density. Men with hair thinning and a diagnosis of androgenetic alopecia (a common form of hair loss) may be suitable candidates for this study. Participants must adhere to specific guidelines, such as maintaining their usual hair care routine and refraining from starting new hair growth treatments during the trial.

As an unphased trial, this study allows participants to contribute to groundbreaking research in hair regrowth technology.

Will I have to stop taking my current medications?

The trial requires that you do not take any medications, supplements, or treatments for hair growth during the study. If you are using any hair growth medications, you must have stopped them at least 6 months before starting the trial.

What prior data suggests that the Ultra device is safe for hair regrowth?

Research has shown that low-level laser therapy (LLLT) for hair growth is generally safe. Studies have found these laser devices safe for use, with most people experiencing only minor side effects, if any.

For example, one study found that after using LLLT at home for 12 months, participants had more and thicker hair, with very few side effects. Another review of studies concluded that LLLT effectively addresses pattern hair loss and carries a low risk of side effects.

Overall, LLLT appears well-tolerated, making it a promising option for those considering it for hair regrowth.12345

Why are researchers excited about this trial?

Low Level Laser Therapy (LLLT) for male pattern baldness is unique because it uses light energy to stimulate hair growth at the cellular level, a mechanism that differs from standard treatments like minoxidil and finasteride, which focus on altering hormonal effects or increasing blood supply to hair follicles. The laser energy penetrates the scalp to enhance cellular activity and energy production, promoting hair regrowth without the need for topical application or oral medication. Researchers are excited about this treatment because it offers a non-invasive option with minimal side effects, potentially making it a safer and more convenient alternative for patients.

What evidence suggests that the Ultra device is effective for hair regrowth?

Research has shown that low-level laser therapy (LLLT), provided in this trial as the Ultra Treatment, can help individuals with male pattern baldness grow more hair. One study found that participants using LLLT experienced noticeable improvements, gaining about 25 more hairs per square centimeter. This therapy improves the hair growth cycle, reduces hair loss, and thickens each hair strand. It likely works by boosting blood flow and stimulating hair follicles, encouraging hair growth. Additionally, a review of several studies confirms that LLLT effectively treats pattern hair loss, with many users seeing positive results.23467

Are You a Good Fit for This Trial?

This trial is for adults aged 22 to 70 with male or female pattern baldness, who are willing to use the study device as directed and not change their hair care, diet, or exercise routines during the study. Participants must avoid other hair growth treatments and be able to attend all study visits.

Inclusion Criteria

Willing to undergo study device use
Fitzpatrick skin type I-VI
Willing to maintain current diet and exercise routine throughout study duration
See 6 more

Exclusion Criteria

I have had treatment to my scalp in the past 6 months.
I have cancer or an uncontrolled medical condition.
I have used hair growth medications in the past 6 months.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Ultra device treatment for hair regrowth

12 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Ultra

Trial Overview

The study is testing a Low Level Laser Therapy device called Ultra to see if it helps regrow hair by improving hair density and thickness in people with pattern baldness. The safety of the device will also be monitored.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Ultra TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CynosureLutronic

Lead Sponsor

Citations

Role of Low-Level Light Therapy (LLLT) in Androgenetic ...

LLLT has been reported to stimulate hair growth in men and women in androgenetic alopecia (AGA) and was approved by the US FDA in 2007.

A Systematic Review and Meta-analysis of Randomized ...

Results indicated increased hair growth on the shaved-off areas of animals' backs. The efficacy of LLLT has since been investigated by many scientists, and the ...

Low-level laser therapy in androgenetic alopecia

By regulating the hair cycle, LLLT reduces hair loss and enhances hair density and diameter, leading to a significant clinical improvement in hair loss. However ...

12 Months of Low-Level Laser Therapy at Home Improves ...

A 48-week trial showed significant hair density and thickness improvements with LLLT in AGA patients, with a mean gain of 25 hairs/cm² and 15% ...

Low dose laser therapy for hair loss

Improvement is reported in at least some users after 12 to 26 weeks of use, with reduced hair fall and noticeable hair growth. How is low level laser hair ...

Low-Level Laser (Light) Therapy (LLLT) for Treatment of Hair ...

LLLT for hair growth in both men and women appears to be both safe and effective. The optimum wavelength, coherence and dosimetric parameters remain to be ...

Long‐Term Efficacy and Safety of Low‐Level Laser ...

In addition, a 2018 systematic review concluded that LLLT is an effective treatment for pattern hair loss, with average gains of approximately ...