Alan J. Bauman M.D.'s personal notes--www.BaumanBlog.com

LLLT hair growth mechanism theories explained by Harvard PhD

This is an update to a prior post:  http://baumanmedical.typepad.com/follicleblog/2009/05/hamblin_lllt.html

Dr. Hamblin, PhD 'sheds some light' on theories of LLLT hair growth mechanisms...

Download LLLT for hair regrowth_hamblin.pdf (106.5K)

The Science Behind LLLT--what are the mechanisms of action of laser therapy?

American Society for Photobiology

 

Symposium: 7-8 AUG / U of Rochester / NY USA

Over the past 40 years there have been many seemingly extraordinary claims of successful treatments of a wide range of diseases, dysfunctions and injuries through the use of “low-level” laser (or light) therapy (LLLT). Many different terms have been used - from LLLT to “biostimulation,” “photobiomodulation,” and other terms. Claims ranging from wound healing, analgesia, reduction of inflammation and nerve regeneration have been seriously questioned by the scientific community and met with great skepticism by much of the medical community. Since irradiances are below levels that produce any significant increase in tissue temperature, it is generally agreed that if these photobiological treatments are real, then they are photochemical rather than photothermal in nature. Although there are now FDA-cleared LLLT treatments and growing acceptance from some quarters, the scientific acceptance has been routinely set back by poorly designed, less-than-rigorous experimental and clinical studies.

Clearly presented photobiological dosimetry and recognition of fundamental methodology in the field of photobiology have frequently been lacking. The aim of this ASP symposium is to explore the scientific evidence for the photobiological mechanisms behind LLLT—from molecular biology to cell and tissue level, and to review those clinical results that appear to be well founded. Ample time has been planned for discussion after each review of the key scientific

questions from action spectra to temporal and spatial factors that appear to influence outcome.

Register at: www.pol-us.net/ASP_Home/asp_meet.html

FDA considering new 510(k) approval category for non-invasive 'fat burning' laser (Zerona)

"Fat Burning" is in quotes here because while we all know that low level lasers are non-thermal, the news media has adapted this slightly inaccurate term to describe the Zerona laser.  I guess "Laser Fat Zap" or "Fat Burning Laser" sounds better than 'fat leaking' -- which is, in fact, what the low level lasers in Zerona causes adipocytes (fat cells) to do... leak.

There are some rumblings from the FDA that regarding the Zerona laser, which has been demonstrated in scientific clinical trials to significantly decrease body circumference in two weeks, they (the FDA) are considering creating a 'new' category within the "Low Level Laser / Photobiomodulation" division of their 510(k) market approvals to reflect body-contouring and fat reduction. 

This has absolutely nothing to do with the specifications or safety of the Zerona device, but rather the proven body contouring effect Zerona demonstrated in the clinical trials.   So much for those people who believe that FDA 510(k) clearance is only about safety!   An FDA 510(k) approval is typically based on a predicate or pre-existing device, but because none such device exists that non-invasively reduces fat like Zerona, a new category will likely have to be created.   

We'll know within the next few weeks the FDA's decision.   For clarification, the laser in the Zerona device has already received 510(k) market approval from the FDA for use as an adjunct to Liposuction.   However, the studies submitted to the FDA show that the Zerona can be used non-invasively to significantly reduce the circumference of the hips waist and thighs without surgery, in two weeks.

For more information on Zerona lasers in Florida, visit http://www.baumanmedical.com/Default.aspx?tabid=157 or www.bocalipo.com.  

Clinical Data on Zerona -- Presentation at 16th Annual American Academy of Anti-Aging Medicine

Las Vegas, NV--The presentation of the data from the randomized, double-blind, multi-center, placebo-controlled study on the Zerona was given on December 11, 2008 at the American Academy of Anti-Aging Medicne 16th Annual Meeting in Las Vegas.   The data showed a statistically-significant reduction in the individual and total combined circuferences of the hips, waist and bilateral thighs after two weeks of treatment using Erchonia's Zerona Low Level Laser.  Scientific background was presented by Dr. Ryan Maloney and the clinical data/clinical experience presented by Dr. Alan J. Bauman.   For more information regarding Zerona in Florida or around the United States, visit www.bocalipo.com or email doctorb@baumanmedical.com.      

Every patient treated at Bauman Medical Group in Boca Raton Florida using the Zerona laser has lost inches.   Zerona is a non-invasive, non-surgical fat-reduction treatment that has been proven to help patients lose inches of stubborn fat from their hips, waist and thighs.  The Zerona Laser is FDA-cleared.

Watch the ABC news investigative report on Zerona on YouTube.com... http://www.youtube.com/watch?v=TynqPeXtRLI

Zerona on ABC-News, featuring Bauman patient, Jody Jack

Watch The Video

Jody had successful treatment with the Zerona Laser from Erchonia. Aside from losing inches off her hips, waist and thighs, Jody felt that she looked a little 'leaner' in terms of muscle definition. The benefits of the Zerona treatment were confirmed by double-blind, randomized, placebo-controlled, multi-site, Independent Review Board-approved clinical studies which have been submitted to the FDA. The Zerona device is seeking it's second FDA-clearance at this time--it has already been cleared for its use as an adjunct to liposuction. The Zerona process, however, is a non-surgical fat-reduction treatment. (post updated 2/5/09)

ZERONA laser zaps fat on EXTRA! TV show

This week, the newest non-invasive fat-reduction treatment will be seen on Extra! TV.   The entertainment news program will discuss how the clinical trials proved that ZERONA helps patients lose up to 9.5 inches in just two weeks with no pain, no surgery, no recovery, no needles, no downtime.

 

The ZERONA treatment is available in South Florida in Boca Raton at Bauman Medical Group.

More on Zerona, Mistakenly called 'verona'

Some of the original studies on Zerona were done at Dr. Douglas Dedo's clinic in Palm Beach Gardens, Florida.   A short news clip on one of his patients aired last night on ABC Palm Beach WPBF: http://www.wpbf.com/health/17557043/detail.html

Unfortunately, they mispelled and mispronounced the name of the treatment...

It's called ZERONA, not VERONA.    The Zerona (not Verona) is performed with the Erchonia FDA-cleared LipoLASER.    As described, six treatments over the course of two weeks.   The average patient loses 5 to 6 inches without change in diet or exercise.   However, we do recommend special adjuncts to the regimen (like compression garments, etc.) to faciliate the body contouring process and enhance the result.  The painless laser device is located in our clinic in Boca Raton.  For more information on the Zerona (not verona) process for body contouring and fat reductions, call toll free 1-877-561-LIPO[5476] or 561-394-0024. 

Laser Lipo Process=ZERONA (not Verona) for fat reduction/body-contouring

News from Erchonia Medical, Inc. makers of the FDA-cleared LipoLASER.

http://www.erchonia.com/default.asp?contentID=121

"Verona" is a city in Italy.  Zerona is a non-surgical fat-reduction/body-contouring treatment using a painless laser.   For more information on Zerona (not Verona) at Bauman Medical in Boca Raton, Florida, call 561-394-0024 or email doctorb@baumanmedical.com

FDA and Low Level Laser Approval

This information is posted on the FDA website regarding the need for clinical data to receive a 510k market approval for Low Level Laser Therapy Medical Devices.   

BIOSTIMULATION LASERS
“Biostimulation lasers, also called low level laser therapy (LLLT), cold lasers, soft lasers, or laser acupuncture devices, were cleared for marketing by FDA through the Premarket Notification/510(k) process as adjunctive devices for the temporary relief of pain. These clearances were based on the presentation of clinical data to support such claims. FDA will consider similar applications for these and other claims with the decision to require clinical data being made on an individual basis, taking into consideration both the device and the claim.”

Read more at
http://www.fda.gov/cdrh/consumer/laserfacts.html

It is a fact that 10% of all 510(k) clearances given by the FDA require clinical data.

Low Level Laser and Wound Healing_Dyson

The physiological effects have been studied extensively by one of the world's most eminent biologists and editor of Gray's Anatomy, Prof. Mary Dyson.

The effects of low level or low intensity laser therapy (LLLT or LILT) on the three overlapping phases of wound healing, i.e. inflammation, proliferation and remodelling, are such that acute injuries heal more rapidly and that healing can be induced in chronic lesions such as venous ulcers/ pressure sores and diabetic ulcers. The duration of acute inflammation can be reduced by LLLT, the proliferative phase of repair, during which granulation tissue is formed, beginning earlier . The rate of wound contraction can be altered and angiogenesis increased.

Healing involves the interaction and activity of many different cell types. Research has been carried out on the effects of LLLT on keratinocytes, mast cells, macrophages and fibroblasts. Keratinocyte and fibroblast proliferation can be stimulated directly and also indirectly through growth factors released from irradiated macrophages.

The effect on keratinocytes is particularly marked when the cells are maintained in adverse conditions similar to those produced by injury. The mast cell content of both intact and injured skin increases following irradiation, but only in injured skin is mast cell degranulation increased. This suggests that the sensitivity of mast cells to stimuli such as light is increased in injured tissues. Some of the materials released when mast cells degranulate can initiate the inflammatory response of the skin to injury, whereas others stimulate later processes such as angiogenesis. Work on cells involved in repair, namely endothelial cells, pericytes and lymphocytes is in progress.

--------------------------------------------------------------------------------

References

Steinlechner C, Dyson M: The effect of low level laser therapy on the proliferation of keratinocytes. Low Level Laser Therapy. 1993; 5 (2): 65.

Steinlechner C, Dyson M: The effect of low level laser therapy on the proliferation of keratinocytes. Low Level Laser Therapy; 1993; 5(2): 65.

Dyson M, Young S: Effect of Laser Therapy on Wound Contraction and Cellularity in Mice. Lasers in Medical Science. 1986; 1: 125.

Dyson M: Cellular and subcellular aspects of low level laser therapy. Progress in low level laser therapy. Eds. T. Ohshiro and R.G. Calderhead, John Wiley & Sons, England. 1991, p. 221

Bolton P A, Young S R, Dyson M: Macrophage responsiveness to light therapy. A dose response study. Low Level Laser Therapy. 1990; 2: 101-106.

Bolton P A, Dyson M, Young S R: The effect of polarised light on the release of growth factors from the U-937 macrophage-like cell line. Low Level Laser Therapy. 1992; 4: 33- 42.

Cheetham M J, Young R S, Dyson M. Histological effects of 820 nm laser irradiation on the healthy growth plate of the rat. Low Level Laser Therapy 1992; 2: 59.

Bolton P, Young S, Dyson M. The direct effect of 860 nm light on cell proliferation and on succinic dehydrogenase activity of human fibroblasts in vitro. Low Level Laser Therapy. 1995; 7: 55-60.

el Sayed S O, Dyson M. Effect of laser pulse repetition rate and pulse duration on mast cell number and degranulation. Laser in Surgery and Medicine. 1996; 19 (4): 433-437.

Nicolopoulos N, Dyson M et al. The use of laser surgery in the subtotal meniscectomy and the effect of low-level laser therapy on the healing potential of rabbit meniscus: an experimental study. Lasers Med Sci. 1996; 11 (2): 109-115.

Steinlechner C, Dyson M: The effect of low level laser therapy on the proliferation of keratinocytes. Low Level Laser Therapy. 1993; 5 (2): 65.