Home is Where...Your Aesthetic Clinic is!

In households up and down the country many a bathroom has been temporarily converted into a make shift beauty salon come hairdressers for everything from at-home hair dyeing to bikini waxing. We all want to save time, money and the perceived hassle of seeking out a quality professional service so if there’s a potential solution that we can do ourselves, in the comfort of our own home, most of us will give it a try.

Add to this the collection of epilators, foot spas, hair crimpers and curlers that live in the bottom of most women’s wardrobes and you can soon see that we have been more than happy to try at-home solutions for several decades.

However, this time honoured practice has now stepped yet further into the 21^st Century and the technological age with the launch of a variety of home use electrical and light based devices designed to zap away unwanted hair, acne, wrinkles and sagging faces in the comfort of our own homes. Once the domain of medical aesthetic clinics, spas and beauty salons, manufacturers of lasers and light devices are now expanding their existing knowledge and technology into producing smaller, over-the-counter products to meet the growing at-home demand; with many having received U.S. government approval in the last six months. To give them even more of an edge, and a somewhat guaranteed entry into the high street, many are also teaming up with big names in the retail beauty and skincare industry to assist with the sales and marketing to this profitable marketplace.

According to a report published in April 2008 by Medical Insights, retail sales of home use devices in the USA are expected to rise by 32.9% per year, on average, from an estimated $255.1 million in 2007 to more than $1.0 billion in 2012.

So what is currently available for the home clinic?

At Home Laser/IPL Hair Removal

Laser hair removal has been around since the 1990s and is now one of the most popular non-surgical treatments available in clinics up and down the country. Yet, with treatment courses for smooth legs starting from around £900 upwards, with no guarantee that future top-up treatments won’t be required, many consumers are looking for a cheaper alternative. Professional waxing is considered both painful and similarly costly, whilst at-home shaving, sugaring and waxing is both timely and just as expensive cumulatively over the years. So, a niche market has evolved for over-the-counter laser hair removal devices which aim to replicate in-clinic results using a safe at-home solution.

In December 2006, Palomar Medical Technologies announced that it had become the first company to receive US Food & Drug Administration (FDA) approval for an over-the-counter, home use, light-based hair removal device, allowing the device to be sold directly to consumers in the United States upon launch. The device, registered with the FDA as the ‘ABC Hair Removal System’ is composed of a base unit, umbilical cord, hand piece, chiller system with chiller coolant, cleaning wipes, ABC lubricant, power supply and safety components. It is rumoured to be a diode laser which will cost in the region of $1,200 (approx. £600) and is being developed by Palomar and commercialised in conjunction with The Gillette Company (part of Procter & Gamble), already famous as the leading manufacturer of razors. So far, no device has actually been launched but is anticipated sometime in 2008.

It is also worth noting that as well as an agreement with P&G for a laser hair removal device, Palomar has an exclusive development and license agreement with Johnson & Johnson Consumer Companies to develop and potentially commercialise home-use, light-based devices for reducing or reshaping body fat including cellulite, reducing the appearance of skin ageing, and reducing or preventing acne; proving that major laser manufacturers are very keen to tap into the home-use device marketplace.

In 2003, a team of American dermatologists, engineers, and executives, who were previously behind the development of the Lumenis diode laser LightSheer™ back in the early 1990s, the first laser to receive FDA approval in America for ‘permanent hair reduction’, went on to found SpectraGenics. They then began the development of its flagship diode laser device for home use, TRIA™, which was subsequently launched in the UK in early 2007. TRIA™ alsoreceived FDA approval as an over-the-counter, home use, light-based hair removal device in February 2008 allowing it to go on sale in the USA.

The device which is compact, hand-held and rechargeable offers 3 settings (high, medium and low) for the level of energy delivered, which can be chosen by the user based on their own comfort levels, although the higher setting is likely to produce the better results. There is no requirement for gels or chilling components.

So far TRIA™ is only available in the USA and the European countries of Italy, Spain and the UK, plus in Japan where it has been on sale since 2005 and where it has sold over 12,000 units in the last year under the brand name i-epi™.The TRIA™ retails in the UK for £695.00 and is currently selling at a rate of over 100 units per month.

A recent clinical trial claimed that the device was not only safe and effective for home use, but that users experienced both excellent short-term, single-treatment hair removal and excellent sustained hair removal with periodic treatments. The only observed side effect was mild-to-moderate redness, which typically resolved in less than 30 minutes, and slight pain during treatment.

No comparative studies have been published evaluating the effectiveness of the TRIA™ against any of the different laser or intense pulsed light systems used by professional clinics.

Meanwhile in March 2008, Home Skinovations Ltd announced that its device Silk’n™ has also been cleared by the US FDA for home-based hair removal, although this device carries the added clearance statement of “home-based removal of unwanted hair under the direction of a physician”, meaning that the device cannot be bought over-the-counter like the preceding two examples, but will be available in the USA exclusively through physicians on prescription.

Unlike the Palomar device and the TRIA™, Silk’n™ is not powered by a diode laser but by an Intense Pulsed Light source, known as the proprietary technology Home Pulsed Light™ which emits wavelengths of 475 – 1,200nm in conjunction with an internal cooling fan. Although hand-held it is required to be plugged into a mains electricity feed during treatment, which could limit manoeuvrability. Additionally, as the device is based on a pulse light solution it uses a bulb to generate the flashes of light every 3.5 seconds. The bulb is said to be good for a lifetime of 750 flashes, which is quoted as enough to carry out multiple treatments on the legs or underarms only. A warning light system on the device informs the user when a replacement bulb is required. With Silk’n™ expected to be available for sale in the USA soon at a cost of $800 (approx. £400) the added ongoing cost of bulbs could make this device less price competitive in the long term. Silk’n™ is not currently available in the UK.

The efficacy and safety of Silk'n™ was tested in a US and Israeli multi-centre clinical study over the last 12 months. A total of 150 patients treated themselves with the device in the physicians' offices with the initial and post-treatment hair counts monitored by the investigating physicians. An average reduction of 50% in the hair count was monitored three months post three bi-weekly treatment sessions. No adverse effects were noted in the course of the study, (although redness and slight swelling is possible following treatment), and the users were quoted as recording an extremely high level of satisfaction with the device and their results.

The device is not recommended for use on the face and like the other devices should not be used on dark skin types due to the risks of burning and skin pigment damage.

At Home Facial Treatments

Syneron, the company behind the patented elos™ (electro-optical synergy) technology, incorporated in such devices as Velasmooth™, Refirme™ and Matrix IR™, announced at the start of 2007 that it had entered into a 10 year, global, exclusive agreement with Procter & Gamble (and its Beauty Division) to develop and supply home-use devices for the enhancement of skin appearance through the treatment of fine lines, wrinkles, age and sun spots as well as cellulite. Any devices generated by this partnership will be marketed under the P&G family of skin care products, possibly Olay®, and will be co-branded with Syneron’s elos™ technology. Retail prices are expected to be sub $1000 (approx. £500), although replacement parts may also be required which could increase costs. No details are currently available about specific products or launch dates.

RejuvaWand™ from Light Dimensions has been available in the USA since it launched in February 2007. Retailing at $200 (approx. £100) it claims to be the first, home-based, skincare appliance to use both red and infrared LED light (Light Emitting Diode) combined with a gentle massaging action (known as Rejuva™ Vibe) to stimulate the production of cellular energy in the skin and increase the circulation to help reverse the signs of ageing. Used in conjunction with their own Rejuva™ Gel product, which is claimed to improve the transmission of light from the RejuvaWand™ to the skin, the device is applied once per day for 4 minutes to each area you wish to treat, (upon which it will automatically switch off), for a period of 60 days, with results claimed to be visible after 30. Ongoing a twice weekly regime is recommended to maintain results. During this time the treatment is alternated from one day using the red light (627nm at 9J/cm²) to one day using the infrared light (850nm at 9J/cm²) throughout the treatment cycle.

A skincare range, including cleansers, toners and moisturisers is also recommended to work in tandem with the RejuvaWand™ treatments to achieve the best results. It is currently not approved by the US FDA, although an application has been placed.

Results of a clinical trial with RejuvaWand™ conducted by a member of the American Society of Laser Medicine and Surgery (ASLSM) involving 36 women, (with an average age of 50 years), with wrinkles around the eyes, who carried out over 4,000 treatment sessions at home over a 60 day period showed that 77.5% of participants (28 women) exhibited a 16.5% improvement in fine lines, facial wrinkles and skin texture. Some have criticised this trial for both the limited sample size and the lack of a split evaluation, looking at one group using the skincare products alone and another using them in conjunction with the RejuvaWand™ device to conclusively evaluate the exact benefit or otherwise of the addition of the light source to the skincare range, given that the Rejuva™ Gel product, whose key ingredient is hyaluronic acid, could produce the improvements in skin texture and lines alone.

A similar device, which came to the U.S. market in September 2007, is the nuLase system which claims to be the ‘first ever laser enhanced skincare treatment for use in the home’. The system which includes the nuLase Soft Touch Laser (along with a skincare range) uses a low-level laser energy with 5mw of power emitting a wavelength of 660nm (red light) again designed to stimulate the production of cellular energy within the skin cells to facilitate a rejuvenating effect. Despite the name, this laser device is in fact a Light Emitting Diode (LED) as characterised by the lower power level.

The nuLase package (which retails online at $329, approx. £165) includes the battery powered Soft Touch Laser device, a foaming cleanser, an exfoliator and a moisturiser which is designed to be used as a daily three-step process for all skin types. After applying the three-step skincare range the Soft Touch Laser is then traced across the skin for 3 – 10 minutes. The manufacturers claim that the device helps to clear up acne, reduce wrinkles, fade age marks and diminish stretch marks; however significant clinical data is lacking.

The NuFace® at-home facial toning device was given FDA clearance in November 2007 for safely and effectively improving the appearance of the face through the use of micro-current technology for cosmetic use. The device is powered with a 9-volt battery and emits micro-currents through two, fixed, chrome-plated spheres or probes which are moved over the surface of the skin through a conductive derma gel previously applied. The settings can be adjusted from 0 – 400 microamps according to personal comfort levels, with treatment described as anything from a tingle to a sting.

NuFace® should be used once daily and is designed to stimulate and improve the muscle tone of the face and neck, thus improving the tightness of the skin. It should not be used in the orbit of the mouth and eyes or over the Adam’s apple region, by pregnant women or by those people with pacemakers and implanted electrical devices or those with a history of seizures.

According to a third party efficacy study, five test subjects used NuFace® for 5 minutes a day for 30 consecutive days. The study revealed a 67% reduction in fine facial lines and wrinkles, 13% reduction in sagging skin, 31% reduction in skin roughness and surface irregularities. Although this demonstrates a certain level of clinical success, the limited number of participants doesn’t really give clear proof of results.

Available over-the-counter in the USA for $379 (approx. £190), the NuFace® Kit includes the device, derma gel, post-treatment optimising mist, user manual, instructional DVD and a one year warranty.

NuFace® has also received CE Mark approval allowing for it to be sold in the UK and Europe where it is available through a variety of online shops for the higher price of £299.

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 (around the eyes) using their GentleWaves® LED Photomodulation technology. This technology, already with a firm foundation in the hands of clinicians, has been scientifically proven to reduce the appearance of fine lines and wrinkles through a system of pulsating amber coloured LEDs which stimulate collagen production without causing any heat build-up in the tissues or associated pain and downtime.

In order to facilitate their entry into the at-home market Light BioScience has 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 we will watch this space with anticipation.

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 has been clinically proven to reduce fine lines and wrinkles around the eyes by up to 70% using a combination of alternate infrared (830nm) and red (633nm) light therapy, based on treatments twice a week for four weeks.

Photo Therapuetics also have a similar device being launched for the home treatment of acne which uses alternating blue (415nm) and red (633nm) light therapy called the Omnilux Clear-U™. A clinical trial of this device showed a clearing of 70% of acne lesions after 4 weeks of treatment.

Although both of these devices are aimed at the at-home market, the company states that they see them as an adjunctive treatment alongside routine clinic visits and as ongoing maintenance, rather than as a replacement for professional Omnilux™ treatment programmes.

Both devices were launched into the US market first at a price of $350 (approx. £175). European practitioners were given a brief taster at the renowned IMCAS meeting in Paris in January 2008 and pending negotiations regarding the global distribution contracts the devices are expected to be available for sale in the UK, both through physicians and over-the-counter, towards the middle of this year.

Summary

With such a multitude of home-use devices now available, both here and in America, designed to treat a variety of aesthetic indications, it seems that we could be somewhat spoilt for choice!

Just like when choosing in-clinic treatments, the decision should come down more on the side of efficacy than cost alone. With one of the main manufacturing criteria for production of at-home devices being firmly planted in the need for safety, the ability to produce comparable in-clinic results is of course compromised somewhat. Devices need to be created to avoid the potential for harm, which could occur with medical grade machines, were they to be used by the layperson. For this reason, some devices are just simply not powerful enough to successfully carry out the job that they are marketed for on the vast majority of people; others will simply take longer to achieve the expected results than if the treatment were to be sought in a clinic environment with stronger energies. Such increased levels of required treatments with an at-home device could tire the patience of the average person and lead to disappointment in the machine quite early on. Persistence is often the name of the game.

For these reasons it is perhaps better to view these at-home devices as adjunctive therapies rather than stand-alone solutions to be used alongside a managed programme of medical aesthetic treatments, as a top-up or maintenance following the in-clinic regime.

Those at-home devices which can ultimately demonstrate a body of clinical data will be the ones who eventually succeed and come to dominate the marketplace. With the rise in online forums and discussion groups, any device seen to be lacking after much marketing hype will soon find itself out of favour with the home user no matter how cheaply it prices itself.

With this industry set to grow exponentially, we’ll certainly be keeping an eye on the winners and losers in the coming few years.