We consider handheld lasers to be safe devices that can be used for hair application. There appear to be no safety issues concerning their use and, although the current scientific studies are lacking, they may be beneficial for some people.
One caveat, however, may be that the long term use of LLLT devices for hair loss hasn’t been adequately studied, and that long term side effects could show up in the future.
Because some LLLT devices for hair loss have been cleared by the FDA, many people feel that they must be safe and effective. However, FDA clearance and FDA approval are different things.
Obtaining FDA approval is a far more stringent process, with clinical trials required to prove that the drug or device is both safe and effective.
Backing up medical claims
Devices intended for cosmetic use don’t generally require FDA clearance or approval. However, one device, called the LaserComb did require FDA clearance because it made a medical claim, that it would promote hair growth in males with certain types of balding.
To obtain FDA clearance, the company had to submit both safety and effectiveness data. The effectiveness data was obtained from a multicenter, randomized, placebocontrolled trial conducted at four sites in the U.S. FDA approval requires a much more rigorous process.
In this study, participants used the laser comb or a “sham” (placebo type) device three times a week for six months. In fact, a major limitation of this study is that the treatment period was only six months with relatively infrequent use, so that the longterm results and safety issues are unknown.
Another problem was that the studies don’t appear to have been double blinded (in a double blinded study, the doctors and patients involved don’t know who’s getting the sham treatment and who’s getting the laser treatment) and it’s not clear whether the participants may have agreed not to use other treatment modalities, so there’s the additional problem of potential biases in the measurement of mean terminal hair density.
In other words, the doctor’s doing the assessing may have found more hair in the patients who got the actual treatment because they expected to.
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This article was sent to us by:
Lionel Venera at
06192010
1. Diagnosing the cause of hair loss before beginning LLLT therapy
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