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:
See more
See less

HairMax Achieves New Milestones in Hair Growth

  • Filter
  • Time
  • Show
Clear All
new posts

  • HairMax Achieves New Milestones in Hair Growth

    This Press Release was just released on the results of the recent clinical studies of the HairMax in males and the subsequent FDA Clearance for marketing of 3 new devices.

    April 21, 2011, Boca Raton, FL – Lexington International, LLC is pleased to announce that it has successfully completed 2 clinical studies of the HairMax LaserComb proving the efficacy and safety of 3 new devices for the treatment of androgenetic alopecia (hereditary hair loss). The analysis showed that 95.4% of participants using the HairMax LaserComb experienced hair growth. Furthermore, the average increases in hair count for participants in the HairMax LaserComb group was 20.4 hairs per centimeter square, which is considered medically and scientifically significant. None of the participants in the studies experienced any serious side effects. Based in part on submission of clinical results, the FDA Granted Class II Clearance 510(k) K103368 of these medical devices for sale in the USA for the ‘Treatment of Hair Loss and Promotion of Hair Growth’ in males.

    The two double-blind, device-controlled multi-center studies were conducted by Zoe Draelos, MD, David Goldberg, MD, Michael Jarrett, MD, and Abe Mercadis, MD, under GCP (Good Clinical Practice) guidelines and IRB (Institutional Review Board) approval. These clinical trials are posted on Submission of these data was a major component of the FDA filing and was a key factor in the agency’s decision to clear the HairMax LaserComb. The FDA 510(k) Clearance further validates the HairMax as a non-drug option for treating hereditary hair loss in males.

    The FDA indication of use for the new models is as follows:
    “The HairMax LaserComb® is indicated to treat androgenetic alopecia, and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and Fitzpatrick Skin Types I to IV.”

    Since 2001, Lexington has completed a total of seven clinical studies with 460 subjects and all of the studies have demonstrated the efficacy and safety of the HairMax LaserComb. 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.


    Visit the website:
    Follow us:
    Access the HairMax Blog:
    Online ordering of the HairMax LaserComb:
Sorry, you are not authorized to view this page