I know there has been a tremendous amount of skepticism regarding this technology and I just want to share with you my thoughts, as fellow colleagues. If anything, it is continuing the valuable discussions we have here in our group that compels me to write this.

If you are not familiar with this study, it involved the use of a swine model. This is an area I am most proficient with. I was a veterinary technician before I became a nurse. I used to run the "pig labs" for clinical research and physician training for a major medical device company and have much experience in 510K clinical trials and was well regarded as a swine expert. I tell you my background only to hope you find validity in my critique.

My biggest problem is with the 300 lb.Yucatan pigs they used in the study. There are many categories of swine for use in experimental procedures and research with some being favored for one reason or another. The more proper Yucatan pig to use for any transdermal study is a Yucatan micro-pig (about 30 pounds) which has a skin thickness similar to that of human skin, and they are relatively hairless. This breed of pig was specifically bred in the swine labs at the Colorado State University in 1978.

I'm not certain as to why these researchers decided to use 300 pound Yucatan pigs with their incredibly thick skin and coarse hair. Perhaps they thought a pig was a pig. Perhaps they wanted to see if the Erchonia laser could penetrate steel... perhaps they know something about research pigs I don't My point is, there is more to this study than what seems to be "obvious" to some.

Here are two famous references I can direct you to to validate my statement that they used an inappropriate swine model:

1. Comparisons of in Vitro Nitroglycerine (TNG) Flux Across Yucatan Pig, Hairless Mouse, and Human Skins. Journal of Pharmaceutical Research. Springer Netherlands, publisher. ISSN: 0724-8741, Vol 7, Number 6. June 1990.

2. Fujii M, Yamanouchi S, Hori N, Iwanaga N, Kawaguchi N, Matsumoto M. Evaluation of Yucatan micropig skin for use as an in vitro model for skin permeation study. Biol Pharm Bull 1997 Mar; 20(3):249-54.

My other problems with the study include:

1. The pig underwent one ZERONA session, not the standard protocol of 6 (3 a week for 2 weeks).

2. No flushing niacin or any substantial vasodilator was used to facilitate fat transferral out of the interstitial space.

3. The Erchonia lasers were positioned 12 inches above the skin when they shouldn't be any further away than 6 inches.

4. The pig was immediately euthanized on the operating table after the single treatment. How are the adipocytes supposed to render any changes in morphology if the host is dead?

Clinical studies are always under scrutiny and this study is no exception. I'd bet a guess that you will start seeing more positive reviews of the ZERONA low level laser in the months to come. And, I base this on the sheer science of the technology. Only time and true trials of the device will tell.

Author: Paula D. Young RN runs internal operations and training at Young Medical Spa and is the author of the Advanced IPL & Laser Training course for medical estheticians and laser technicians.

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