BB&T Contributing writer

SAN ANTONIO — The National Cancer Institute estimates that more than 1 million new cases of skin cancer were diagnosed in the U.S. in 2007, resulting in more than 10,000 deaths, of which about 80% were from melanoma. Most of these cases are basal cell and squamous cell carcinomas. They are curable, but treatment can leave noticeable scars or whitish spots.

About 62,000 cases of melanoma were diagnosed in 2006, and about 7,900 people died of this cancer, which increases about 3% each year. There is currently no cure for advanced-stage melanoma.

Melanoma was the most serious condition discussed at the 66th annual meeting of the American Academy of Dermatology (AAD; Schaumburg, Illinois), attracting more than 13,000 attendees. But the conference also was marked by the full spectrum of dermatological offerings, ranging to the growing sector of home-use systems, overall offering a cornucopia of the newest device technologies in the field.

This broad variety of products paralleled the overall diversity of the conference. International representation included more than 1,500 attendees from more than 80 countries. More than 550 scientific posters were presented at the meeting, with more than 400 companies exhibiting on 99,855 net square feet of floor space.

Reducing biopsies

Diagnosis of skin cancer traditionally involves invasive biopsies. However, performing biopsies of multiple lesions to be certain of a diagnosis is not always practical and can be painful and traumatic for the patient.

Researchers are therefore developing non-invasive techniques with which to identify such cancers. It is anticipated that some of these techniques, alone or in combination, will improve the ability to differentiate melanoma and non-melanoma skin cancers from their simulators. Ultimately, these advances may prevent unnecessary biopsies (via increased specificity) while increasing the sensitivity of the diagnosis. Although some imaging techniques may hold great promise, they cannot replace the physician-patient interaction and a visual skin cancer screening examination as the cornerstone of a diagnosis.

Marie-France Demierre, MD, associate professor of dermatology at Boston University, reported that mortality from melanoma is rising, especially in older age groups, and so prevention is the best strategy for impacting mortality.

As primary prevention, the performance of sunscreens has recently been improved with the introduction of high SPF and the availability of broad spectrum agents. Effective secondary prevention consists of skin self-examination and physician examination.

Innovations in imaging

New imaging systems are aiding in the early detection of skin cancers.

Electro-Optical Sciences (Irvington, New York), a publicly traded company, is developing its MelaFind device, not yet FDA-cleared but in a Phase III trial. MelaFind is a non-invasive, hand-held, point-of-care imaging device for use in the early diagnosis of melanoma. It emits light of multiple wavelengths of visible and infrared light to obtain data from images of suspicious pigmented skin lesions. The device uses sophisticated classifier algorithms developed from a proprietary database of melanomas and non-melanoma lesions.

The database of images corresponds to more than 5,000 biopsied lesions from over 3,500 patients, this large database offering a significant barrier to competition. After analysis, a recommendation can be made to the physician as whether or not to biopsy the lesion.

The device consists of several components: an illuminator that shines 10 specific wavelengths of light, including near infrared bands; a lens system composed of nine elements that creates images of the light reflected from the lesions; a photon sensor; and an image processor employing proprietary algorithms to extract discrete characteristics or features from the images.

The company envisions that it will be used as an aid by dermatologists to differentiate between melanoma and benign lesions. Its selling price has not yet been determined.

Last March Electro-Optical reported an exclusive agreement with L'Oreal (Paris) to study and assess the feasibility of using its multi-spectral imaging technology for evaluating and differentiating pigmented skin lesions of cosmetic importance.

Dermoscopy

Dermoscopy is a noninvasive technique that uses a hand-held instrument called a dermoscope or dermatoscope. It is equipped with a transilluminating light source and standard magnifying optics.

Robert Johr, MD, clinical professor of dermatology at the University of Miami School of Medicine (Miami, Florida), chaired a course on dermoscopy, describing it as the standard of care in Europe and other countries but reportedly performed by only 23% of U.S. dermatologists. Dermoscopy was said to significantly increase the accuracy of the clinical diagnosis of melanocytic, non-melanocytic benign and malignant skin lesions. Dermoscopy pinpoints dysplastic moles that need long-term follow-up. Videodermoscopy is the linking of dermoscopy devices to a video microscope for computer analysis and is known as a "mole scanner."

Hand-held instruments combine polarizing filters, light emitting diode (LED) lighting and magnifying lenses to reveal the epidermis, the dermo-epidermal junction and the papillary dermis. A significant learning curve comes into play because the colors and structures that show up are different from those seen with the naked eye. In the past, dermoscopy required placing oil, water or alcohol on the lesion to eliminate surface light reflection, but this is no longer necessary.

Evaluation of pigmented lesions by dermoscopy is complex and subjective. To overcome qualitative interpretation, methods based on mathematical analysis of pigmented lesions have been developed, as provided in the digital high resolution dermatoscopes DermLite, from 3Gen (San Juan Capistrano, California), and Heine Delta20, from Heine Optotechnik (Herrsching, Germany).

The use of subjective algorithms is inefficient and time-consuming for each examination, and it is expected that subjective algorithms will be replaced in the next 10 to 20 years by objective, computerized evaluations supervised by dermatologists. 3Gen's line of hand-held dermoscopes use LED technology and a polarization system for lesion visualization and the early detection of skin cancer. Its DermLite FOTO can be attached to a camera for photographing skin lesions.

Epiluminescence

Macquarie Health (Leichhardt, NSW, Australia) markets MoleMax, an integrated system for digital epiluminescence microscopy and macro imaging that is used to view morphological features, colors and patterns of the skin and sub-surface layers of the skin that are not seen in an examination with traditional skin surface microscopy.

The primary benefits are early detection of malignant melanoma and differentiation between benign and malignant tumors.

Because MoleMax uses digital images, patient data can be easily transferred via the Internet to an international MoleMax discussion group and patients can be sent to other physicians to receive a second opinion. MoleMax has access to a mailbox for dermatologists called Dermanet which can be used for teleconsulting.

Mapping our moles

One of the methods for early detection of melanoma is mole mapping, with that type of system developed and marketed by MoleMap (Auckland, New Zealand), with the company using the name MoleSafe in the U.S. due to trade name issues.

With its system, a full set of body shots is taken to record the current skin condition for use in future monitoring. Typically, a procedure takes one hour to record 50 individual lesions. The recorded imaging data is transmitted to a network of dermatologists who are trained melanographers, using software tools for analysis, assessment and reporting. A central database is used to store data.

Photodocumentation, total body mapping

FotoFinder Systems (Columbia, Maryland) markets dermoscopes and cameras for viewing and photographing moles and for total body mapping as a screen for skin cancer.

Its dermoscopes come in a variety of configurations: Premier for small practices, Portable mobile, with a rolling computer case, and Studio for hospitals and practices that emphasize total body photography. Its Medicam 500 provides 20x to 70x magnification of microscopic images, the imagestransferred from the camera to a central processing unit and entered into the patient database for future comparison.

FotoFinder's dermoscopes use the Bodyscan pro software module that automatically detects new and changed moles on patients with multiple nevi by comparing the clinical images of the prior examination with a recent one.

Its Dynamole software is a diagnostic aid for early detection of malignant melanoma. The software module analyzes the lesion and gives several indications such as size, color and border irregularity and a score of the probability of malignancy is displayed.

Canfield Scientific (Fairfield, NJ) is a supplier of medical imaging software, photographic equipment and computer systems for photo documentation of the skin which can be used for mole mapping and to track changes. It utilizes Mirror DermaGraphix body mapping software for the early detection of melanoma and is marketed to dermatologists and plastic surgeons.

The company operates DermaTrak Skin Imaging Centers to assist physicians in monitoring changes in existing moles, detect the presence of new moles and as an aid in screening melanoma.

It offers total body photography (TBP) in which the skin covering most of the body is documented in a series of sectional photographs. TBP can be used to document the clinical appearance of moles for future reference. Its service is marketed to physicians, who refer their patients to a nearby DermaTrak imaging center.

Canfield's products for cosmetic applications are the Visia equipment which is used for complexion analysis and the Omnia imaging system which documents results of facial rejuvenation therapies.

Laser treatments

Jeffrey Dover, MD, associate clinical professor of dermatology at Yale University Medical School (New Haven, Connecticut), reviewed new laser treatments that provide gentler skin rejuvenation than previously available (Table 2).

Among those that he emphasized was fractional laser skin resurfacing, one of the most versatile new laser technologies.

Numerous clinical studies have shown that this technology is safe and effective in treating patients of all skin types, including skin of color, with fine lines, wrinkles, uneven skin tone, even acne scars.

Fractional laser resurfacing works by targeting damaged skin in columns of microscopic treatment zones, which include the outermost and underlying layers of skin. It thermally damages the tiny columns of skin while the surrounding healthy skin is left intact.

"One of the main benefits of fractional laser resurfacing is that it stimulates the production of new collagen during the body's natural healing process," said Dover. "Not only does the treated skin look better after a series of three to six treatments, but it also improves gradually as the new collagen forms."

Plasma skin resurfacing is new technology that has also shown promise in initial studies at improving skin. Plasma resurfacing uses nitrogen gas to generate plasma energy, which is delivered to the targeted epidermis and dermis in either multiple low-energy or single high energy millisecond pulses.

Over a period of three to 10 days, depending on the level of energy used, the outermost layer of skin remains intact and acts as a "biological dressing" to protect the new epidermis and dermis forming underneath. Patients typically require a week or more of healing time.

A modified version of the Erbium:YAG laser that is widely used for skin resurfacing, known as the superficial Erbium:YAG laser, uses short-pulsed wavelengths to create a gentler treatment with fewer side effects and decreased patient down-time.

Dover noted that this procedure works well for patients with less extensive skin damage, such as mild wrinkles and slight skin discoloration. The resulting mild redness and swelling generally lasts for only two to three days.

Dover also discussed the general paradigm for considering the safety and effectiveness of skin resurfacing technologies. (Table 3).

Aesthetic skin care

Consumer demand is driving innovation in the aesthetic device market. Some predict this sector could reach $1 billion in sales in the next few years.

A growing trend is the use of various kinds of skin treatment devices in the home. These include microdermasion devices for skin rejuvenation and ultrasound and LED-based, non-ablative devices for the treatment of aging and photo damaged skin and for hair removal.

Intense pulsed light and laser treatments are used by physicians for thermal injury to the skin's collagen and blood vessels to effect changes in the skin's appearance. LEDs do not rely on thermal energy and tissue trauma to effect change but use light to stimulate cell receptors and cause them to produce collagen for wrinkle reduction.

Typically, skin rejuvenation by LED requires multiple treatments over a period of several weeks with subsequent maintenance treatments.

One of the first dermatologic applications of LEDs was for photodynamic therapy (PDT) using Levulan (amino levulinic acid, or ALA), a photo activated cream, for the treatment of actinic keratosis. ALA-PDT has also been used to treat basal cell carcinoma, Bowen's disease and sebaceous disorders (including acne). More than 25 presentations and posters addressed PDT.

Michael Gold, MD, Clinical Associate Professor of Dermatology at Vanderbilt University (Nashville), led the third annual course on PDT, attended by more than 200 dermatologists. He noted that PDT "is a cost-effective, first-line treatment modality for patients and will lead to continued advancements in the field of dermatology."

Skincare Technology (Chicago) markets Revitalight, a photo-pulsating LED-based device with detachable hand pieces that emits red light (625 nm) for skin rejuvenation and wrinkle reduction and blue light (420 nm) to treat acne vulgaris for which FDA clearance was granted in June 2005. The light can be focused on special skin problem areas. An optional amber light (590 nm) hand piece is also available for use in pain reduction.

The company also markets the HandSpa for use in wrinkle reduction. These devices are sold worldwide for use mainly in spas but also in dermatology and plastic surgery clinics and practices.

Light BioScience (Virginia Beach, Virginia) featured its Gentle Waves LED photomodulation skin fitness system that employs a panel of visible yellow light (590 nm) to treat the entire face.

Pharos Life (Cambridge, Ontario) has developed the Tanda professional skincare system, an LED-based, non-invasive portable light therapy device. It can be prescribed by physicians for at-home therapy for both acne and anti-aging applications. It includes two treatment solutions, a 414 nm blue LED shown to kill bacteria that cause mild to moderate acne, and a 660 nm red LED that accelerates the skin's natural healing process as well as stimulating the production of collagen for skin rejuvenation.

The product, FDA-cleared, is Distributed by Eclipse Medical (Dallas), the device is FDA-cleared, has the CE mark and is approved by Health Canada.

Photo Therapeutics (Carlsbad, California) introduced the Omnilux New-U with switchable near-infrared (830 nm) and red (633 nm) LEDs contained in the same hand piece for use on fine lines and wrinkles with two treatments per week for four weeks.

The company's Omnilux clear-U with switchable blue (415 nm) and red (633 nm) LEDs in the same hand piece is for the treatment of mild to moderate acne. Omnilux PDT is for the treatment of a wide range of dermatological conditions, including acne, photo damaged skin, non-melanoma skin cancers, skin rejuvenation, vitiligo and wound healing post elective surgery.

SpectraGenics (Pleasanton, California) has developed the TRIA home-use hair removal device which utilizes an eye-safe diode laser (810 nm) and rechargeable battery. It recently received FDA clearance for use on light-skinned subjects.

It has three settings (low/medium/high) and the user senses some heat. The skin is shaved and then illuminated with laser light which is absorbed into the hair shaft to destroy the hair follicles. More than 15,000 devices have been sold at $1,100 to $1,200 in Japan (brand-named i-epi) and in three European countries.

The safety, efficacy and ease-of-use of the TRIA hair removal device was evaluated by Ronald Wheeland, MD, past president of the AAD and the American Society for Dermatologic Surgery (ASDS ; Rolling Meadows, Illinois) and published last year in Lasers in Surgery and Medicine. The company plans to sell its devices through dermatologist and via select retail partners.

Light Dimensions (Palo Alto, California) markets RejuvaWand, a hand-held skin rejuvenation device for minimizing visible signs of aging. It uses two LED light sources, red (627 nm) and infrared (850 nm). Treatment is also combined with a gentle massaging action for enhanced efficacy. For optimal results, the RejuvaWand is recommended for once-daily use, alternating the wavelengths between red and infrared. Treatment is provided for pre-programmed lengths of four minutes. Palomar Medical Technologies (Burlington, Massachusetts) is collaborating with Gillette, a subsidiary of Procter & Gamble (Cincinnati), in the development of a home-use light-based hair removal device for women. This program is being renegotiated and announcement of an extension is expected shortly.

Palomar also has a collaboration with Johnson & Johnson (New Brunswick, New Jersey) to develop home-use, light-based devices for skin rejuvenation, acne and cellulite.

Clairsonics (Bellevue, Washington) displayed its sonic skin care cleansing brush for the improved absorption of moisturizers and serums and for enhancing microabrasion procedures. It is marketed to dermatologist and spas and is also sold in some high-end retail shops.

The device was reviewed in a poster at the meeting as an adjunct to prescription treatment for rosacea and for use in combination with topical therapies for treating photoaged skin.

Two ultrasound-based aesthetic devices are being incubated by Guided Therapy Systems (Mesa, Arizona).

Xthetic is developing a hand-held, battery-powered product for the consumer aesthetic device market. Its initial aim is for developing a device to treat and prevent acne, to be followed by products for skin rejuvenation and for treating inflammatory skin conditions. Ulthera is developing a professional skin care system that uses high frequency ultrasound for treating wrinkles as well as for lifting and tightening the skin for a non-surgical facelift.

The ultrasound heats and destroys the targeted tissue which triggers a wound healing response and new tissue production, but it does not damage the epidermis or the intervening layers of skin that it passes through.

WaveBlend Technologies (Chicago) has developed a combination ultrasonic/electrical stimulation device for skin rejuvenation and for painless delivery of topical skin care products. Treatment begins with a diamond dermal planning disc which exfoliates the top layer of skin. This is followed by treatment with modulated and collimated ultrasound combined with congruent electrical energy to stimulate collagen synthesis.

Positioned for sale to dermatologists, plastic surgeons and medical spas, list price for the unit is estimated at about $19,500.

Advanced Cosmetic Intervention (Centennial, Colorado) has introduced its GFX technology which received FDA clearance in June 2007. The GFX treatment applies a controlled dose of radio frequency energy, known as Thermal Ellipse, to the motor nerves that are typically treated with neurotoxins for brow lift surgery, and it is being used commercially. Once a low-intensity stimulator precisely locates the motor nerves, the Thermal Ellipse is then applied. Clinical trials are underway to evaluate the efficacy and longevity of GFX, with the results utilized in an FDA application later this year for reduction of frown lines.