The Future’s Bright...The Future’s LEDs?

We last looked at Light Emitting Diode (LED) technology back when we launched The Consulting Room™ website in the summer of 2003. A lot has happened with regard to available treatment options within the aesthetic arena in the last 6 years so we thought it was about time that we reviewed this area again.

LED technology is now routinely being offered in clinics as

treatment for both skin rejuvenation, using red, infra-red and yellow coloured light and for acne using blue LEDs. However, these are not only being offered in clinics nationwide but are now available as hand-held units for home use.

So how can the little lights that we see in many everyday electrical items help restore our skin’s youthfulness and improve our complexion?

What are Light Emitting Diodes?

According to Wikipedia™, the LED was first invented in Russia in the 1920s. Technically speaking it is a semi-conductor diode that emits light when an electric current flows through it in a forward direction (i.e. from the anode to the cathode). The colour of the light emitted depends on the chemical composition of the semi-conducting materials used to make the individual LED.

Having started initially with red lights, advances in chemical science have led to the ability to create a wide variety of colours or wavelengths of light using LEDs, including infra-red light, visible light and ultraviolet light.

A single LED on its own does not offer much light but by combining multiple LEDs in an array or matrix pattern, manufacturers are able to produce devices with large panels of LEDs with increased levels of light.

LED Technology in Aesthetic Medicine

The use of LED technology in aesthetic medicine is often referred to by many marketing terms such as photorejuvenation, photomodulation and biostimulation and is targeted as an alternative treatment to laser and IPL devices for reducing wrinkles, sun damage and acne, or as a combination treatment.

Unlike laser and IPL, LEDs work non-thermally (i.e. without generating heat) so they do not destroy or injure tissue. Due to this there appear to be very few significant side effects from using LEDs, apart from in those individuals with known photosensitivity (sensitivity to light), epilepsy and porphyria (a rare genetic condition which also causes light sensitivity amongst its many symptoms).

Like lasers and Intense Pulsed Light (IPL) systems, the properties of the different wavelengths of LED light can be used to target and treat the skin in many ways, because the different tissues and cells in the skin that are being targeted have their own light absorption characteristics and thus absorb only specific wavelengths or colours of light. Commonly LEDs with wavelengths of infra-red, red, yellow and blue are used in aesthetic medicine and claim to activate the relevant absorption spectrum within biological systems to produce a number of photobiological responses, including stimulating the production of collagen or destroying acne causing bacteria.

For example, studies have shown that red light therapy can stimulate collagen precursors and enzymes associated with skin cell remodelling and blue light can target the natural chemicals called porphyrins which are produced by acne causing bacteria known as propionibacterium acnes or P.acnes. The porphyrins are sensitive to light and if stimulated with blue light will neutralise and eradicate the bacteria, thus reducing and eliminating the inflammation of acne.

Some clinicians also combine the use of LED technologies with existing ablative, non-ablative and fractional laser treatments where a more aggressive application is required to treat the skin damage. In such cases the LEDs can be used post-laser treatment to reduce redness, swelling and promote quicker healing of the treated skin, which dramatically reduces the downtime of the patient, something which more and more people are concerned about given work and family commitments.

In general LED therapy treatment programmes are created for between 6 and 10 sessions, often spread 2 or 3 days apart over a period of 3 to 4 weeks, often with a maintenance regime every month or so once the initial programme is completed.

Various manufacturers of laser and light based aesthetic systems now produce LED based devices to compete in this marketplace, but the industry leaders remain those companies who first launched this technology for mainstream cosmetic applications, namely Omnilux™ and Gentlewave®. With a wealth of data behind the devices it is these that we will focus our discussion on.

Omnilux™

The first LED system to be launched in the UK for photorejuvenation was the Omnilux™ platform from Phototherapeutics Ltd (now part of PhotoMedex Inc). The company claim that over 3300 dermatologists worldwide have been using professional Omnilux™ products to successfully treat wrinkles and the effects of ageing for more than a decade.

Their range of professional, in-clinic treatments includes the Omnilux revive™, Omnilux blue™, Omnilux plus™, and Omnilux PDT™ interchangeable heads for the treatment of a wide range of dermatological conditions including acne, photodamage, non-melanoma skin cancers, skin rejuvenation, vitiligo and wound healing post elective surgery.

Along with a proven history in large scale, in-clinic devices they have now ventured into the at-home market with the recent introduction of Omnilux New-U™ and Clear-U™. These devices will be discussed in more detail later in this article.

The history of the Omnilux™ system dates back to 1988 when Dr Colin Whitehurst, working at the Paterson Institute for Cancer Research in Manchester, built the first prototype of the Paterson PDT, pure red light source using LEDs. Phototherapeutics Ltd was created in 1999 to actively promote the device to the global market under the name Omnilux PDT™.

It was designed as a safe and potentially lower cost alternative to using lasers for Photodynamic Therapy (PDT) for minimally invasive cancer treatment that could be portable and easier to use in clinical practice. PDT is a combination treatment using a photosensitive chemical such as 5-aminolevulinic acid (5-ALA) and a light source to treat various skin conditions.

By 1999 this technology had undergone clinical trials in over 1000 patients in UK Hospitals for the treatment of precancerous skin lesions and during the trials it was noted that the skin around the treatment areas showed a significant improvement in both quality and texture. This subsequently led to the development and introduction of a cosmetic counterpart for the platform, named Omnilux Revive™, designed for skin rejuvenation, which entered the UK marketplace in 2003.

The Omnilux Revive™ treatment head delivers red light at a wavelength of 633nm which the company note is proven to stimulate cellular mechanisms responsible for tissue repair and regeneration.

In a 2005 study conducted at Lasercare Clinics (now rebranded as Sk:n) in Birmingham entitled “a single-blinded randomised controlled study to determine the efficacy of Omnilux Revive facial treatment in skin rejuvenation”, 23 volunteers were treated on one half of their faces 3 times a week for 3 weeks. 91% of patients reported visible changes to their skin with 64% reporting a reduction in fine lines and wrinkles and a perception of softer skin, and 68% reporting smoother skin. Blinded photographic evaluation reported a clinical response in 59% of the volunteers. The therapy was said to be well tolerated with no reported side effects or pain.

Omnilux Blue

Additionally the Omnilux Blue™ treatment head was created around the same time. It delivers blue light at a wavelength of 415nm for the treatment of mild to moderate acne vulgaris which is one of the most common skin conditions worldwide. The blue light destroys the bacteria responsible for producing the acne inflammation. Treatment is often combined with the Omnilux Revive™ as it can also help to reduce redness and inflammation once the bacteria has been neutralised by the Omnilux Blue™.

Finally the Omnilux Plus™ treatment head delivers infra-red light at a wavelength of 830nm. As this light is not visible to the human eye, the manufacturers have placed yellow lights in the corners of the LED array so that it is possible to see when the lights are lit and operating, to avoid accidental use.

The Omnilux Plus™ is designed for treating skin rejuvenation and is often used in combination with the Omnilux Revive™ head as it has been shown in many trials that the combined wavelengths offer a good result.

The Omnilux Plus™ is also used for wound healing and the manufacturers are looking into its use for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and to temporarily increase local blood circulation where it is applied.

In a 2005 U.S. study by Dr. B.A. Russell et al entitled “A study to determine the efficacy of combination LED light therapy (633 nm and 830 nm) in facial skin rejuvenation”, 31 patients with facial wrinkles received 9 treatments combining the 633nm wavelength of the Omnilux Revive™ and the 830nm wavelength of the Omnilux Plus™.

The individuals were then evaluated for improvements in skin surface at weeks 9 and 12 with 52% showing a 25-50% improvement in photoageing scores by week 12 and 81% of patients reporting a significant improvement in periorbital wrinkles (wrinkles around the eyes, often referred to as crow's feet).

As well as combining the infra-red qualities of the Omnilux Plus™ with the Omnilux Revive™, a study published just this month by renowned Dermatologist Dr. Neil Sadick looked at combining the Omnilux Plus™ with the Omnilux Blue™ in a paper entitled “A study to determine the effect of combination blue (415 nm) and near-infrared (830 nm) light-emitting diode (LED) therapy for moderate acne vulgaris”.

This pilot study took 17 patients, (only 11 completed the study), with varying skin types and grading of acne severity who underwent twice-weekly 20 minute LED treatment sessions alternating between the blue and infra-red light for 4 weeks. No other treatment, such as topical skincare application or microdermabrasion was allowed. Results were assessed and at 1, 4 and 8 weeks post-treatment.

Patients showed improvement ranging from 0% to 83.3%, but a downward shift in their acne grading was seen overall. Non-inflammatory lesion counts increased in 4 patients, but improved in the other 7 by an average of 48.8%, with no adverse effects reported.

Dr Sadick concluded in this first of a kind study that this combination therapy of Omnilux Plus™ with the Omnilux Blue™ produced results which were less effective in reducing the inflammatory lesions associated with acne than those previously reported as achievable with the combination therapy of Omnilux Plus™ with the Omnilux Revive™; i.e. red and blue light worked better than infra-red and blue light in the treatment of acne. However he noted that further study on a much larger patient group is required to fully verify this theory.

Gentlewaves®

The GentleWaves® LED Photomodulation Device by Light BioScience Inc. has also been available in the UK since 2003. It was given U.S. FDA clearance for the non-invasive treatment of periorbital wrinkles in 2005. The company states that it is actively researching other applications of the platform, including treatment protocols to improve acne, thinning hair, cellulite and wound healing.

The GentleWaves® LED Photomodulation Device consists of a cascading array of over 2,000 yellow (590nm wavelength) LED lights, which unlike other LED devices on the market are sequenced to pulse on and off at millisecond intervals.

In a multi-centre study reported by Light BioScience of 90 female patients who underwent 8 GentleWaves® treatments, 62% were said to have achieved improved appearance of skin around the eyes, 36% around the upper lip, and 26% achieved improvement of skin roughness around the eyes. A continued improvement in their appearance was observed for 4 months after the last treatment session with high patient satisfaction reported.

Another study published by Dr. Robert A. Weiss et al in 2005, entitled “Clinical Experience with Light-Emitting Diode (LED) Photomodulation” looked at experiences over a 2 year period of 900 patients (3,500 treatments) using GentleWaves®.

LED photomodulation had been used alone for skin rejuvenation in over 300 patients but was also shown to be effective in augmenting the results in 600 patients who received other facial rejuvenation treatments before the application of LED using devices such as non-ablative intense pulsed light, pulsed dye laser, KTP and infrared lasers, radiofrequency energy and ablative lasers.

Dr. Tina Alster took this concept further in April 2009 when she looked at the “Improvement of Postfractional Laser Erythema with Light-Emitting Diode Photomodulation”, where she chose to investigate whether LED treatment immediately after fractional laser skin resurfacing affects the severity and duration of post-procedural erythema (redness).

20 patients received LED treatment to one half of their face immediately after undergoing full-face fractional laser skin resurfacing with a 1,550nm erbium-doped fibre laser. Differences in erythema between LED-treated and untreated facial halves were recorded at 24, 48, and 96 hours post-treatment. Results showed that the sides of the face treated with the LED were indeed less red for the first 24 hours with results becoming less discernible as time went on. She concluded that the application of LED photomodulation does decrease the intensity and duration of redness caused post treatment with fractional lasers.

Such findings are very useful to demonstrate how LED technologies can be used as a successful adjunct to achieving an overall facial rejuvenation result from combined use with other modalities such as IPL, laser and radiofrequency.

The actual treatment with the GentleWaves® LED, in terms of time spent in front of the bank of LEDs takes less than one minute, if the treatment is being performed in isolation. However often a gentle exfoliation of the skin is done prior to the GentleWaves® LED session with facial masques, microdermabrasion and chemical peels being the most common methods of exfoliation used by clinicians.

Depending on the area being treated, a programme of 8 to 10 treatments is recommended which can be delivered once or twice a week. Results are said to be progressive with more correction being noticed after each treatment. Noticeable changes are generally reported after 5 to 7 treatments.

At-Home Devices

In-clinic LED devices, as we have seen, have been around in the UK for over 5 or 6 years now. Despite increases over the years in the number of clinical studies and available data to quantify their usefulness within aesthetic medicine, you may be wondering why we are writing about this in terms of a hot topic. Well as of this year LED technology became available in the UK for use at home!

In April this year the Good Housekeeping Research Institute in America published a piece based on five recently introduced LED devices which they had put to the test to see if their anti-ageing claims stacked up. Volunteers followed each manufacturer's protocols, using the handheld devices from daily to once a week for between four to six weeks. The magazine noted that “with very few exceptions, testers' fine lines and wrinkles were unchanged after the prescribed periods”.

Good Housekeeping failed to publish a list of exactly which five devices they tested but did feedback on two devices which they claimed were the best with improvements to sun damage, pores and skin texture from laboratory evaluations. These were the Evis M.D. Platinum Red LED Rejuvenating Facial Light and the Tända Regenerate Anti-Aging Starter Kit. Neither of these devices are currently sold in the UK.

As discussed in a previous Consulting Room™ Feature Article published a year ago, where we looked at the wide range of home use aesthetic devices now entering the U.S. and European markets, we noted that in February 2008, Light BioScience announced the first FDA over-the-counter clearance for a home use, light based device designed to treat periorbital wrinkles using their GentleWaves® LED Photomodulation technology.

In order to facilitate their entry into the at-home market Light BioScience had also signed an agreement with L’Oreal for collaboration on the development and commericalisation of skincare devices using the GentleWaves® technology. As yet nothing has been brought to market but clinical trials sponsored by L’Oreal are currently underway.

Later, in March 2008 Photo Therapeutics Inc. also announced a similar FDA approval for the Omnilux New-U™ device, cleared as an over-the-counter light therapy device also for the treatment of periorbital wrinkles and based on their existing Omnilux™ LED technology.

The device uses a combination of alternate infrared (830nm wavelength) and red (633nm wavelength) light therapy.

An independent clinical study published by Dr. Neil Sadick in December 2008 entitled “A study to determine the efficacy of a novel handheld light-emitting diode device in the treatment of photoaged skin” looked at the Omnilux New-U™ device.

Twenty two patients with facial wrinkles received 8 treatments with the handheld Omnilux™ device (both red and infrared lights) over the course of 4 weeks. Their skin was assessed at weeks 6, 9 and 12 using global skin grading, along with clinical photography and patient satisfaction scoring. 74% of patients were said to report a visible improvement in fine lines and wrinkles at 8 weeks post the treatment programme.

Although impressed with the performance of the Omnilux New-U™ as an “effective and acceptable method of photo rejuvenation”, he did note that further studies are required to optimise the parameters of treatment required.

The current home treatment recommendation is two 20 minute alternate infra-red and red light treatments per week for 4 weeks; however there is no limit to the number of treatments you can have as there is no danger to the skin from the use of the device.

The Omnilux New-U™ is supplied with a range of skincare packs which the manufacturers claim are specially formulated to maximise the results of using the Omnilux New-U™. They include a preparation cleanser, a treatment serum containing co-enzyme Q10, retinol and various anti-oxidants and an aftercare serum with vitamins E and C.

Photo Therapeutics also have a similar looking device being launched for the home treatment of acne which uses alternating blue (415nm wavelength) and red (633nm wavelength) light therapy called the Omnilux Clear-U™. This mirrors the findings of the use of combination blue and red light for acne as discussed above with regard to the professional devices.

A further independent study by Dr. Neil Sadick entitled “The Use of a Novel Handheld LED Array Device in the Treatment of Mild to Moderate Acne Vulgaris” looked at 21 patients between the ages of 14 and 21 years using the Omnilux Clear-U™ for a period of 4 weeks.

Each person received alternate blue and red light, 20 minutes for blue and 30 minutes for red from the device which was held in contact with the treatment area by the individual. Significant reductions in inflamed acne lesions were noted after the treatment period was completed with an average reduction of 69% at a 12 week assessment.

74% of participants rated the product very easy or extremely easy to use.

Similarly the Omnilux Clear-U™ is supplied with a salicylic acid based preparation cleanser, a treatment serum containing willow bark extract for unclogging and reducing pores and an aftercare serum.

Both of these devices are aimed at the at-home market and available to buy through various locations, however the company states that they see them as an adjunctive treatment alongside routine clinic visits and as ongoing maintenance, rather than as a complete replacement for professional Omnilux™ treatment programmes.

Both devices were first launched into the US market at a recommended retail price of $350 (later reduced to $295) and are now available in the UK for an RRP of £225.

It is also worth noting that N.V. Perricone M.D. skincare manufacturers have launched the Light Renewal™ device which is a re-badged version of the Omnilux™ New-U under their own branding. It differs from the original version only in that it is sold in conjunction with the N.V. Perricone Nourishing Milky Cleanser and Serum Prep for use as a combination programme. This sells in the UK for the same price as the Omnilux™ New-U.

Summary

In many cases it could be concluded that LED therapies can and do compete head to head with non-ablative lasers and IPL systems for photorejuvenation and acne treatments. However this is very much dependent on the severity of the indications being targeted where more aggressive treatments such as fractional or ablative lasers may be required. Either way there is a place for LED treatments in the armoury of the aesthetic practitioner who can use it as a stand alone treatment with successful results or as a combination treatment to both enhance achievable results and minimise downtime and recovery.

Ideally comparative trials are required in order to assess the clinical differences and efficacy of the competing technologies, although with so many different lasers, IPL and LED systems currently on the market, interpreting any results could be difficult, even if such trials occurred. To this end, most trials, as with many other aesthetic devices and products, have focused on combination therapies with LED used post laser/IPL aimed at achieving a desired result by the most effective combined means of treatment rather than by simply relying on one ‘miracle’ treatment alone.

The safety of LED devices has now seen their easy entry into the home use market. Such introductions, you would think, would strike fear into the hearts of aesthetic practitioners who may think that their days of offering in-clinic treatments are numbered if everyone can do it in the comfort of their own bedrooms. However, small scale home use devices are exactly that. The range of treatments, intensities and power settings available to the home user is restricted and preset for obvious safety reasons. This means that such devices are intended, in the main, for use as a maintenance tool for both during and after an in-clinic treatment programme for a particular indication whereby the practitioner has been able to set specific treatment protocols with his more advanced professional equipment and the home use device is there as an adjunctive tool.

With fewer and fewer of us wanting to take time out of our lives to recover from cosmetic treatments; the fact that LEDs have been shown to offer improvement in skin rejuvenation and acne without any visible deleterious alteration in the skin’s surface makes them a very attractive proposition and one which we feel is here to stay.

Reproduction or republication of this article is strictly prohibited without prior written permission from The Consulting Room™.