Review of Boulos PR et. al. In the eye of the beholder–skin rejuvenation using a light-emitting diode photomodulation device

http://www.ncbi.nlm.nih.gov/pubmed/19215260

Dermatol Surg. 2009 Feb;35(2):229-39.

In the eye of the beholder–skin rejuvenation using a light-emitting diode photomodulation device

Boulos PR, Kelley JM, Falcão MF, Tremblay JF, Davis RB, Hatton MP, Rubin PA

Review copyright 2009 https://aestheticdevicereview.wordpress.com

In an unusual article, Boulos and colleagues present compelling evidence that the GentleWaves LED device simply does not work, and that patient satisfaction is simply the result of a placebo effect.

In this study, 36 patients were treated with the GentleWaves device weekly for 8 weeks, as suggested by several other researchers.  Standardized photography was performed pre-treatment, immediately post-treatment, and 1 month post-treatment.  The unblinded investigator also performed clinical assessments at the same time points.

Thirty raters were asked to select the “after” photo from a randomly ordered before/after pair, looking at one of five aspects of the treatment – redness, wrinkles, dark spots, skin roughness, and general appearance.  Unfortunately, the results were not different from chance.

The data were re-evaluated by using a consensus of three raters for each aspect.  Still, the results were no different from chance.

Next, statistical power was increased by using raters’ confidence in their own judgements to weight the data.  In other words, this analysis more highly weighted the decisions that the raters felt sure about, and underweighted the decisions where the raters felt unsure.  Nevertheless, results again were not different from chance.

Finally, the unblinded investigator’s clinical assessments showed that “there was essentially no effect, or if anything, a negative effect.”

Despite the lack of any objective evidence of improvement whatsoever, patients were quite pleased with the results.  The authors conclude that the treatment is a classic placebo, where patients feel better because they believe that the treatment will work, even though it does nothing.  At AestheticDeviceReview, we would like to see more devices subjected to this type of study.

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One Response to Review of Boulos PR et. al. In the eye of the beholder–skin rejuvenation using a light-emitting diode photomodulation device

  1. Hardly a quantifiable presentation of results. This device was FDA approved for periorbital wrinkling and that approval was based on a more objective analysis of the device. Inherent limitations in photography include fluctuations in lighting, head position, facial expression and asymmetries. Summarily, the use of skin replica optical profilometry to complement subjective evaluations with an objective method for the quantification of skin surface texture changes with minimal variability or potential for bias should have been utilized. Despite the argument against photographic evidence, there are numerous photographs available demonstrating cross-sectional results that agree: less redness, diminishment of fine periorbital lines, and even microscopic photos showing the more even topographical texture of skin attributed to the more even arrangement of collaganous fibers. And who were these “thirty raters”? Dermatologists? Medical professionals qualified to assess such results? Arnold Schwarzneggar, Harry Chaplin, and John DenInherent limitations in photography include fluctuations in lighting, head position, facial expression and asymmetries. Consequently, the use of skin replica optical profilometry to complement subjective evaluations with an objective method for the quantification of skin surface texture changes with minimal variability or potential for bias was utilized.
    er all purportedly went to their own “Look alike” contests and all were booted out of the initial running and one of them was accused of looking nothing like themselves. So much for human “objective” analysis. There’s too much evidence supporting the FDA’s claims in this case so I’m siding with them. But the reason this is arguable is because the results of photomodulation are minimal and rather than making a person look younger, they only look like a person of similar age with slightly better skin. This light device is not a face lift-something I would hardly recommend anyways.

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