Landmark HairMax LaserComb Clinical Study Results Published, Proving Efficacy and Safety In Treating Hair Loss

The results of 4 clinical studies conclusively proving the efficacy and safety of the HairMax LaserComb was published in a peer review medical journal in April 2014 and here is a summation of the article.

"The results of four clinical studies on the treatment of male and female pattern hair loss with the HairMax LaserComb, was just published today in a peer-review journal, The American Journal of Clinical Dermatology. The article, Efficacy and Safety of a Low-level Laser Device in the Treatment of Male and Female Pattern Hair Loss: A Multicenter, Randomized, Sham Device-controlled, Double-blind Study was co-authored by renowned experts in the field of hair disorders. The results of these studies have now provided robust and conclusive evidence that the HairMax LaserComb is both effective and safe for the treatment of pattern hair loss in men and women.

This is the link to the clinical article:

The four clinical studies were conducted under strict Good Clinical Practice Guidelines at multiple study sites, including major teaching institutions of dermatology such as the Cleveland Clinic, University of Minnesota and University of Miami. Enrolled in the study were 225 males and females diagnosed with androgenetic alopecia (male and female pattern hair loss). Subjects received either the HairMax LaserComb or a sham (inactive) device in a randomized, blinded manner so that no one knew which device they were on. The primary efficacy analysis was based on the change in hair count after 26 weeks treatment with the HairMax LaserComb, compared to change in hair count with the sham (inactive) device.

The results of the studies showed that there was an average increase in terminal hair count of over 20 hairs per cm² (equivalent to over 139 hairs per square inch). Additionally, a higher percentage of lasercomb-treated subjects reported overall improvement in hair loss condition and thickness and fullness of hair in self-assessment, compared with sham-treated subjects. No serious adverse events were reported in any subject receiving the lasercomb in any of the studies.

The authors concluded that: “Our results suggest that low-level laser treatment may be an effective option to treat pattern hair loss in men and women”. They also concluded that “Low Level Laser Therapy [LLLT] may provide a promising treatment option for patients who do not respond to either finasteride or minoxidil, and who do not want to undergo hair transplantation.”

The authors also had this overall observation: “…… while topical minoxidil solution or foam is widely used to treat pattern hair loss and is generally well tolerated, the treatment needs to be applied one or twice daily, and be in contact with the scalp for at least 4 hours. Such application can be impractical for many users, leading to noncompliance and reduced efficacy. As an alternative, the lasercomb treatment is safe and easy to apply, with 8-15 minutes of treatment three times per week, and leaves no residue on the scalp. Such user friendliness of the lasercomb may lead to better patient compliance and improved efficacy.”

Dr. Lawrence Schachner, Chairman of the Department of Dermatology at the Miller School of Medicine of the University of Miami, and senior author of the article said: “The results of these clinical studies provide further evidence that the HairMax LaserComb may be utilized as an effective option for treating androgenetic alopecia in men and women.”

You can view a video of the lead author of the clinical paper, Dr. Lawrence Schachner and Dr. Joquin Jimenez discussing the clinical paper at this link:
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HairMax LaserComb is Now FDA Cleared for the Treatment of Female Pattern Hair Loss

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  • HairMax LaserComb is Now FDA Cleared for the Treatment of Female Pattern Hair Loss

    HairMax is now FDA Cleared for the Treatment of Female Pattern Hair Loss

    Lexington International, LLC has just released the following Press Release:

    "First At-Home Device Granted FDA Clearance to Treat Female Pattern Hair Loss Recieved for the HairMax LaserComb

    For the first time in over twenty years, a new home-use treatment for female hair loss is available. Lexington Intl, LLC, is excited to announce they have received historic and groundbreaking FDA Clearance for marketing for the HairMax LaserComb® Lux 9 to treat female hair loss and promote hair growth. Included as a key part of the submission was a multi-center clinical study proving the efficacy and safety of the HairMax.

    The Official FDA Clearance Letter can be viewed here;

    “Hair loss amongst women is a growing concern”, says Dr. Matt Leavitt, Medical Advisor to Lexington. “In the past, women had only one FDA Approved drug ingredient to treat their hair loss. Now they have a clinically proven viable alternative. Upon review of Lexington’s extensive clinical studies on female hair loss, the FDA has granted Clearance to this exciting new treatment option. I believe the HairMax will be able to offer help to the millions of women suffering from hair loss.”

    The last hair loss treatment for women to be approved by the FDA was minoxidil, which came to market for females in 1988. The HairMax is now the first non-drug, home-use OTC medical device cleared to treat the estimated 80 million men and women suffering from hereditary hair loss.

    The HairMax Lux 9 is indicated to treat Androgenic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I-IV.

    What Causes Female Hair Loss?

    · Aging

    · Changes in the levels of androgens (hormones). For example, after reaching menopause, many women find that the hair on their head is thinner, while the hair on their face is coarser.

    · Family history of male or female pattern baldness

    · Damaged hair due to coloring or chemical straightening treatments

    What Are the Signs of Female Pattern Hair Loss?

    Hair thinning is different from that of male pattern baldness. In female pattern baldness:

    · Hair thins mainly on the top and crown of the scalp. It usually starts with a widening through the center hair part.

    · The front hairline remains

    · The hair loss rarely progresses to total or near total baldness, as it may in men

    Clinically Proven

    The results of a double-blind, device-controlled clinical study conducted under Good Clinical Practices showed that 100% of subjects on the HairMax Lux 9 experienced hair growth at 6 months. Furthermore, over the same period of time, females using the HairMax Lux 9 grew an average of 20.5 hairs per centimeter squared, which is considered medically and scientifically significant. Most importantly, over 70% of the subjects using the HairMax Lux 9 reported improvement in thickness and fullness of their hair. No serious side effects occurred and there were no other types of side effects caused by the HairMax Lux 9 in the study.

    The HairMax LaserComb Lux 9 clinical trial was conducted at five research locations in the United States. The investigators were, Janet Hickman, MD, Michael Jarrett, MD, David Goldberg, MD, Jose Mendez, DO, and Abe Marcadis, MD. The double blind study compared the HairMax Lux 9 to a control device so that the investigator, the subjects, nor the evaluator of the hair counts knew which device the subject was using. The protocol for the study was approved by an IRB (Investigational Review Board) and monitored by a CRO (Contract Research Organization). The trials were listed on which is a registry of federally and privately supported clinical trials conducted in the United States and around the world.

    How Does the HairMax Work?

    How does the HairMax LaserComb work so effectively? It harnesses the power and technology of laser light. The HairMax delivers safe and effective laser energy to stimulate dormant and active hair follicles. The most common example of light being converted into cellular energy is photosynthesis; where plants convert light into cellular energy. Scientific studies on hair cell cultures have shown that laser light penetrates into the hair follicle and increases the action of adenosine triphosphate (ATP), a molecule that is a major carrier of energy in all living cells.

    The HairMax Lux 9 is easy to use. Just treat your hair for 11 minutes, every other day, in the privacy and convenience of your own home.

    The HairMax LaserComb is most effective in early to moderate stages of hair loss. By using the HairMax men and women can experience positive results and feel better about themselves and how they look.

    Safe to Use: The HairMax Lux 9 complies with FDA requirements for laser safety. There has never been any reports of serious side effects occurring either in clinical trials or in the 10 years the device has been on the market. The HairMax uses a patented technology to part the hair allowing the focused laser energy to reach the scalp. The laser is most effective when it has an unobstructed path directly to the hair follicle. Through extensive research, Lexington has determined the optimal wavelength and energy level needed to deliver maximum results. Lexington’s continued dedication to consistent innovation ensures that users are always receiving the latest in laser hair technology.

    In April 2011, the FDA also granted Clearance for marketing for 3 new models of the HairMax LaserComb for male pattern baldness.

    Since 2001, Lexington has completed a total of seven clinical studies with 460 subjects. All of the studies have demonstrated the efficacy and safety of the HairMax LaserComb family of FDA Cleared devices. These statistically significant clinical study results validate the fact that the HairMax should be considered as a first line treatment for appropriate people suffering from hereditary hair loss. "


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