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

April 12, 2009

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.

Advertisements

Review of Faurschou A, Pulsed dye laser vs. intense pulsed light for port-wine stains

February 22, 2009

http://www.ncbi.nlm.nih.gov/pubmed/19120324

Br J Dermatol. 2008 Dec 11.

 

Pulsed dye laser vs. intense pulsed light for port-wine stains: a randomized side-by-side trial with blinded response evaluation.

 

Faurschou A, Togsverd-Bo K, Zachariae C, Hædersdal M.

 

Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, DK-2400 Copenhagen NV, Denmark.

 

This study is from the same Denmark group that recently compared the pulse dye laser (LPDL) to the intense pulsed light (IPL) for the treatment of photoaging.  In this study, Annesofie Faurschou reports another head-to-head study comparing these two device types, this time for the treatment of portwine stains.  The study was supported by the laser manufacturer and the local sales agent for the IPL, but neither sponsor participated in the conduct or analysis of the study.  In particular, this study compared the Candela VBeam Perfecta (long pulse 595nm dye laser) with the Palomar StarLux IPL with a Lux G handpiece.

The study was adequately, though not optimally, designed to demonstrate the differences with each type of treatment.  First, each study participant received one split-lesion treatment, with the one half of the lesion randomized to each device type, which properly controls for non-study effects (e.g. additional sun exposure).  The use of a split-face design also appropriately controls for patient variability.  However, the use of a series of multiple treatments would have magnified any possible outcome differences, and would better reflect clinical practice.   Second, one evaluation was performed photographically by a blinded assessor.  Blinding appropriately prevents bias, but the introduction of photographic artifact may obscure outcome differences.  Third, a second evaluation was performed with a skin reflectance meter, also performed by a assessor blinded to device-types used on each half.  Blinding appropriately prevents bias, but this meter has been validated for the use of evaluating erythema and pigmentation rather than portwine stains.

In this study, while both devices achieved measurable PWS lightening and no adverse events were found, the pulsed dye laser showed superior efficacy, both by blinded photographic evaluation and by blinded skin photometer.  The difference in lightening was both statistically and clinically significant (i.e. the difference in lightening was visually apparent to the blinded reviewer and the patient), even though only one treatment was performed.  As far as patient preference, 18 of 20 patients preferred to have subsequent treatments with the LPDL, while 2 preferred the IPL.

The superior results of the pulse dye laser may not be considered definitive based solely on this study, as there was no-pre-defined study hypothesis to be proven.  However, the authors refer to several other studies to underline their proposal that the LPDL be considered the first choice modality for PWS treatment, with the IPL reserved for poor-LPDL-responders.  This is an appropriate guideline.


Review of Jørgensen GF, et.al. Long-pulsed dye laser versus intense pulsed light for photodamaged skin

January 30, 2009

http://www.ncbi.nlm.nih.gov/pubmed/18563775

Lasers Surg Med. 2008 Jul;40(5):293-9.

Long-pulsed dye laser versus intense pulsed light for photodamaged skin: a randomized split-face trial with blinded response evaluation.

Jørgensen GF, Hedelund L, Haedersdal M.

Department of Dermatology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

 

 

In this paper, Gitte Jørgensen reports a rarely seen type of study in the aesthetic space – a randomied comparison of two competing device technologies.  The study was co-sponsored by both device manufacturers, but neither manufacturer participated in the conduct or analysis of the study.  Most aesthetic device studies compare a device treatment to an untreated control, to show that the treatment causes some effect.  In contrast, this study compared the Candela VBeam Perfecta (long pulse 595nm dye laser) with the Ellipse Flex (Intense Pulsed Light) for the treatment of photodamaged skin, to see if the treatments caused different outcomes

The study was well-designed to demonstrate the differences with each type of treatment.  First, the patient population was homogenous (light skin females).  Reduction of patient variability reduces confounding of outcomes and enables smaller sample sizes.  Second, each study participant received a series of 3 split-face treatments with the one side randomized to each device type, which properly controls for non-study effects (e.g. additional sun exposure).  The use of the series of 3 treatments would magnify outcome differences, if there were any.  Third, the evaluation was performed on-site by a blinded, independent physician, to prevent bias and to prevent the introduction of photographic artifact.  Although blinding adequately prevents bias, agreement from multiple blinded observers would be useful to reduce individual subjectivity in the assessment of improvement.

While both devices demonstrated improved outcomes in this study, the long pulse 595nm dye laser achieved overall superior results, due to superior performance on vascular lesions.  Fourteen of 20 patients obtained better clearing of telangiectasias with the pulsed dye laser and the remainder saw no difference.  The difference in lightening was both statistically and clinically significant (i.e. the difference in lightening was visually apparent to the blinded reviewer and the patient). Both devices achieved similar improvements for irregular pigmentation and skin texture.  Neither device showed any improvement in wrinkles/rhytids.  Eighteen of 20 patients preferred the pulsed dye laser, both because of improved vascular clearance and because there was less treatment-related pain.

Despite an excellent study design, there are some limitations to the study conclusions.  The superior results of the pulse dye laser should not be considered definitive, as there was no-pre-defined study hypothesis to be proven.  The study was too small to determine whether there was a significant difference in the rates of adverse effects between the two devices.  Because both devices demonstrated improvement in outcomes, practitioners may be able to achieve pulsed-dye-laser results by simply performing additional IPL treatments.  Possibly, other IPL systems may perform better than the Ellipse product used in this study.


Welcome!

January 29, 2009

Welcome to Aesthetic Device Review, an occasional review of notable articles on aesthetic devices from peer-reviewed publications.