Results of Four Clinical Studies For Male Pattern Baldness and Female Pattern Hair Loss
In January 2014, the results of four clinical studies proving the efficacy of Low Level Laser Therapy in general, and the HairMax LaserComb in particular for treating male pattern baldness and female pattern hair loss, was published in a peer review medical journal.
The title of the article is, 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. Here is the link to the entire article:
Global photographs of a female subject, at baseline (a) and after 26 weeks (b) of the 12-beam lasercomb treatment. Macrophotographs of a male subject, at baseline (c) and after 26 weeks (d) of the 9-beam lasercomb treatment. Increased hair count through conversion of vellus or intermediate follicles to active follicles producing terminal hair (ovals) or resting telogen to active anagen follicles (rectangles) is highlighted.
These studies were sponsored by Lexington, which means that the company paid the costs relative to the conduction of the studies, but were carried out by a third party Contract Research Organization (CRO) with absolutely no input from the sponsor once the studies began.
- This article was a major event in the evolution of the treatment of male pattern baldness, and female pattern hair loss, as the results of the studies described in the article, conclusively proved the efficacy and safety of the HairMax LaserComb, based on the 5 design aspects of the studies.The article was published in a Peer Reviewed Journal – What this means is that the article was subjected to an exhaustive review of its contents by experts from the journal, completely independently from Lexington International. Thus, the article was considered scientifically important and deserving of wide- spread dissemination of the results in treating male pattern and female pattern hair loss to the medical community, in a prestigious journal.
- The clinical studies were multi-centered– This means that they were conducted at multiple major teaching institution of dermatology – The importance of this, is that for the results in male pattern baldness and female pattern hair loss to be credible, the results of the studies at each center, must very closely match the results found at the other centers. When this occurs, it provides conclusive proof that the results will always be predictable and consistent.
- Number of Subjects– There were over 200 men and women diagnosed with male pattern baldness or female pattern hair loss included in the studies, which means that because of this large number, the results are highly predictable and ‘robust’. The subjects covered all of the various demographic factors such as age, to assure that all of them represented a wide range of men and women diagnosed with male pattern baldness and female pattern hair loss
- Device-controlled– To provide conclusive proof that the active device, in this case the HairMax LaserComb was effective, the results had to be compared to a sham or inactive device. The results of the study had to show conclusive and significant efficacy in treating male pattern baldness and female pattern hair loss with the HairMax versus the sham device.
- Double-blinded– The studies on male pattern baldness and female pattern hair loss were conducted without the investigator nor the subject knowing which device they would be treating their condition with. This is vital to assure that there was absolutely no bias in the distribution of the devices. Obviously, if the devices were distributed in a non-blinded manner, those receiving the sham device would not have wanted to participate in the study. Also, the evaluator of the results was also blinded as to which subject received which device, so that the final analysis of the results of the male pattern baldness and female pattern hair loss would be totally unbiased.
So, when you read about so-called ‘scientific’ studies on laser devices to treat male pattern baldness and female pattern hair loss, make sure that the results are based on the 5 vital study attributes mentioned above. Of equal importance is that they MUST include a large number of subject if they are to be considered really ‘scientific’, or just opinion types of studies which have no value. A number of studies have been conducted with just a small number of subjects, or were not double-blinded or conducted with control devices, which makes the results found in treating males pattern baldness and female pattern hair loss, to be meaningless.
The clinical study results from the paper reached this overall conclusion.
“In four randomized, double-blind, sham-controlled trials of male pattern baldness and female pattern hair loss, we detected a statistically significant increase in terminal hair density after 26 weeks of lasercomb treatment compared with sham treatment…. A higher percentage of lasercomb-treated subjects reported overall improvement in hair loss condition and thickness and fullness of hair in self-assessment..’
In conclusion, these ground-breaking studies prove conclusively, that Low Level Laser Therapy in general, and the HairMax LaserComb in particular is an effective and safe first-line non-drug treatment for male pattern baldness and female pattern hair loss. Men and women fighting the battle against hair loss, can use the HairMax with confidence because unlike drugs that are approved for treating hair loss, there have been NO serious side effects EVER reported from using the HairMax LaserComb.