While the HairMax laser comb device was found by the FDA to be safe based on its “substantial equivalence” to previously approved [tag]laser light therapy[/tag] devices and thus “cleared” (not “approved”), it was unclear to what extent the FDA reviewed or cleared it based on its effectiveness in treating [tag]balding[/tag]. However, it appears that this device and similar devices are often touted as being “FDA approved” to treat [tag]thinning hair[/tag].
With very little verifiable data and mostly anecdotal information to support or refute its efficacy, this debate is likely to continue for awhile.
To read more about the experiences of our members and add your own thoughts and comments, join the discussion thread, Laser Hair Restoration, Fact or Fiction? started by Hair Restoration Forum member “jzachary”.
—-
David – aka TakingThePlunge
Assistant Publisher and Forum Co-Moderator for the Hair Transplant Network, the Hair Loss Learning Center, the Hair Loss Q&A Blog, and the Hair Restoration Forum
Get Proven Hair Loss Treatments at the Best Prices by visiting our new Online Hair Loss Product Store
Welcome to XFantazy.com, in which i've gained an educated superheroine rina_vlog porno pornography videos to…
???? v?u? d?v?z ??v??r ?ù ?bt?n?r l? ??d? ?r?m?, ??mm?nt l'ut?l???r ?t ?? qu'?l f?ut…
Gry losowe ciesz? si? niezwyk?? popularno?ci? na ca?ym ?wiecie, a ich powszechno?? w Internecie sprawia,…
Australia Bitstarz provides casino enthusiasts an unique experience that includes timeless slot reels and an…
Participants also can benefit from advantages applications while using notes such as Amex, that will…
? ?????? ?????????????? ???????? ?????????? ???????? ??????????? ??????? ?????????? ???? ?? ?????. ?? ??????? ????????,…
View Comments
Leonard,
Thanks for posting this information. While it certainly appears that the abstract you provided above supports that the HairMax lasercomb may help combat androgenic alopecia, I encourage you to present the whole study rather than just the abstract.
Best wishes,
Bill
Managing Publisher of this Community
I am Leonard Stillman, Director of Professional Services at Lexington International, LLC. This posting is not for commercial purposes, but is to set the record straight on comments made on this post.
This statement is in the entry, "With very little verifiable data and mostly anecdotal information to support or refute its efficacy, this debate is likely to continue for awhile."
The results of a double blind, control device study which was a key part of the 510(k) submission and subsequent clearance for marketing was published in a peer review journal. Below is the abstract of the article from http://www.pubmed.gov.
"Clin Drug Investig. 2009;29(5):283-92. doi: 10.2165/00044011-200929050-00001.
HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial.
Leavitt M, Charles G, Heyman E, Michaels D.
Private Dermatology Practice, Maitland, Florida, USA. mlleavitt@aol.com
Abstract
BACKGROUND AND OBJECTIVE: The use of low levels of visible or near infrared light for reducing pain, inflammation and oedema, promoting healing of wounds, deeper tissue and nerves, and preventing tissue damage has been known for almost 40 years since the invention of lasers. The HairMax LaserComb is a hand-held Class 3R lower level laser therapy device that contains a single laser module that emulates 9 beams at a wavelength of 655 nm (+/-5%). The device uses a technique of parting the user's hair by combs that are attached to the device. This improves delivery of distributed laser light to the scalp. The combs are designed so that each of the teeth on the combs aligns with a laser beam. By aligning the teeth with the laser beams, the hair can be parted and the laser energy delivered to the scalp of the user without obstruction by the individual hairs on the scalp. The primary aim of the study was to assess the safety and effectiveness of the HairMax LaserComb laser phototherapy device in the promotion of hair growth and in the cessation of hair loss in males diagnosed with androgenetic alopecia (AGA).
METHODS: This double-blind, sham device-controlled, multicentre, 26-week trial randomized male patients with Norwood-Hamilton classes IIa-V AGA to treatment with the HairMax LaserComb or the sham device (2 : 1). The sham device used in the study was identical to the active device except that the laser light was replaced by a non-active incandescent light source.
RESULTS: Of the 110 patients who completed the study, subjects in the HairMax LaserComb treatment group exhibited a significantly greater increase in mean terminal hair density than subjects in the sham device group (p < 0.0001). Consistent with this evidence for primary effectiveness, significant improvements in overall hair regrowth were demonstrated in terms of patients' subjective assessment (p < 0.015) at 26 weeks over baseline. The HairMax LaserComb was well tolerated with no serious adverse events reported and no statistical difference in adverse effects between the study groups.
CONCLUSIONS: The results of this study suggest that the HairMax LaserComb is an effective, well tolerated and safe laser phototherapy device for the treatment of AGA in males.
PMID: 19366270 [PubMed - indexed for MEDLINE]"
Also, at the annual meeting of the American Academy of Dermatology meeting in February, 2011 we will be announcing the results of the double blind, controlled device study of the efficacy of the HairMax in females with androgenetic alopecia.
Based on the published study which clearly showed efficacy of the HairMax in males, we take exception to the statement as quoted from the write-up. We would appreciate it if you would quote this to set the record straight