The Aesthetic Guide — November/December 2012
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Automated Microneedling Rivals Energy-Based Tx
Kevin A. Wilson

The aesthetic space is crowded with energybased devices that provide simple treatments and results that patients appreciate. However, a new microneedling device, backed by years of research, has proven itself safe, effective and easy to use, delivering results rivaling more aggressive modalities, at a fraction of the cost.

Providing superior value and potential, Dermapen® from Dermapen LLC (Salt Lake City, Utah) is the latest in microneedle therapy, precisely delivering controlled injuries to the skin at a fraction of the cost of energy-based platforms.This easy-to-use device causes rapidly healing microwounds directly perpendicular to the skin to minimize trauma and patient discomfort.Dermapen is FDA indicated for aging skin, wrinkles, acne scars, striae and surgical scar hypertrophy, with clearances for general dermabrasion, scar revision, acne scar revision and tattoo removal. In addition, U.S. physicians are also using it to perform off-label treatments that improve the delivery of drugs and platelet-rich plasma (PRP).

Dermapen is small and light, about the size of a felt tip marker, and is available in two models, the Medical Model (MD), which may be used to penetrate up to 2.5 mm into the skin, and the Aesthetic Model whose treatment depth is limited for use by aestheticians.The treatment tip consists of a disposable, spring-loaded piston with an array of 11 microneedles protruding from the end. Needle penetration depth may be adjusted between 0.25 mm and 2.5 mm, and the piston stroke frequency may be set as high as 90 Hz, producing almost 1,000 microwounds every second. There is virtually no downtime, and at shallower settings Dermapen is safe enough for use by ancillary personnel.

Gordon H. Sasaki, M.D., F.A.C.S.
Clinical Professor
Plastic Surgeon
Pasadena, CA

Fundamentally, Dermapen’s mechanism of action is simple – controlled delivery of damage to the dermis and epidermis stimulates collagen. While the basic idea behind microneedle dermabrasion therapy has been around for more than a century, the emergence of this therapy in aesthetic medicine didn’t occur until the mid-1990s, according to Gordon H. Sasaki, M.D., F.A.C.S., clinical professor and plastic surgeon in Pasadena, Calif. “The concept of using needles therapeutically was originated by the Chinese many centuries ago with acupuncture for overall health issues,” he noted. “Motor-driven abrasive instrumentation, via Kromayer in 1905, opened the doors for dermabrasion as we know it.”

A less aggressive dermabrasion technique employing acupuncture needles was developed by Swiss-French dermatologist Simonin in the 1980s. In 1995 the Orantrek brothers in Philadelphia, Pa. Began using a bevel needle for ‘subdermal release’ of scars and wrinkles, Dr. Sasaki added. “One year later South African dermatologist Des Fernandes, used a round platform stamp with about 25 embedded needles, each protruding approximately 1 – 2 mm from the surface, for skin rejuvenation based on the idea of stimulating the healing cascade.”

Michael Johnson, M.D.
Head of Research & Development
Dermapen
Salt Lake City, UT

However, according to Michael Johnson, M.D., head of research and development for Dermapen, it was an accidental discovery by Dr. Camirand (published in 1997), that truly paved the way for what is now called percutaneous collagen induction therapy (PCI). “Dr. Camirand was using skin color tattooing with melanocytes as a cosmetic treatment of facial hypochromic scarring. The pigment faded over several years but patients noticed improvements in the color, texture and overall appearance of the scar,” Dr. Johnson began. “Dr. Camirand postulated that it was the perforation by the tattoo gun itself that was responsible for this outcome, and Dr. Fernandes later reported using microneedle dermabrasion for wrinkles on the upper lip, with excellent results.”

Developed by Horst Liebl in 2000, the dermal roller, which is made up of a wheel on a stick-like device featuring a drum bristling with needles to be rolled across the skin, was shown to cause thickening of the dermis and epidermis.Dr. Sasaki explained that in 2006 a study by Schwartz further developed this discovery and coined the phrase ‘collagen induction therapy’. “What’s important about this is that Schwartz demonstrated an approximate 200% increase in collagen from needle penetration alone. This effect was limited to the upper third of the reticular dermis even with deeper needle penetration.”

Recent concurrent research by Aust and Fabbrocini has revealed additional data on the safety and efficacy of this technique, Dr. Johnson reported.“Aust’s work on hand rejuvenation and what he termed ‘scarless skin rejuvenation’ showed that dermal needling did not cause the ablative changes to the skin that are characteristic of other modalities. Additionally, Fabbrocini expanded PCI for successful acne scar revision. So despite being a fairly new therapeutic modality, the base of science and literature behind PCI is actually quite mature.”

This research and evolution has given way to Dermapen. Although the ideas behind Dermapen have been around, technology had to catch up, Dr. Sasaki emphasized. “Microneedling is defined as the use of solid or hollow needles of the appropriate length and diameter to puncture the skin. The ability to manufacture a true microneedle with a diameter measured in microns simply did not exist until more recently,” he elaborated.

Dermapen’s eleven 33-gauge needles are embedded into a disposable applicator. Each needle is 0.02 mm in diameter or 200 microns and the arrangement has a fractional pattern design. The use of disposable tips (one use per patient), which cost about $25 each, prevents cross contamination.An electrically driven piston provides the oscillating motion of the needle array directly perpendicular to the skin‘s surface, creating a stamping effect.“By creating purely vertical intrusions into the epidermis and dermis, trauma is minimized. This is important because research has shown that the use of a roller causes a more traumatic tearing wound,” said Dr. Sasaki.

Also, despite their seeming simplicity, dermal rollers are quite operator- dependent, Dr. Johnson added.“Pressure on the roller can deform skin and cause deeper penetration than intended. Dermapen glides across the skin parallel to the surface, with its tip floating on a layer of hyaluronic acid, which helps the device move evenly, to ensure a consistent treatment. There is little difference in treatment between operators, and it’s easy to maneuver Dermapen around the eyes or nose.”

Treatment parameters with Dermapen are easy to adjust on the fly. “With the handpiece – or ‘pen’ – you can adjust needle depth between 0.25 mm and 2.5 mm, or 250 microns and 2,500 microns,” Dr. Sasaki advised. “The epidermis is only 100 microns in depth, and the reticular dermis averages between 2,500 and 3,000 microns in thickness; so at the lowest setting you’re confining damage to the upper reticular dermis, and at the highest settings you’re penetrating to the lower portion. We generally work between the 0.5 mm and 2.5 mm depths. This variability is important because skin thickness varies at different locations of the face and body. Devices such as the dermal roller do not have this feature and as such they are limited.”

Users may also vary the frequency, or needle piston strokes per second, up to 90 Hz at the highest setting, Dr. Sasaki continued. Slower, more careful work requires slower frequency. “This is a fractional device as well, which means that there is significant undamaged tissue surrounding each micropenetration.All this translates into a reliance on the normal wound healing cascade to rejuvenate skin, stimulated through the safe and controlled delivery of a pattern of micropunctures that heal rapidly.” Adjustments may be made easily during application to account for differing skin characteristics in the specific treatment area such as the face, where skin thickness and corrective needs may vary greatly.

Dr. Johnson explained that in comparison to other rejuvenation technologies, Dermapen is relatively benign.“A fractional laser or radio frequency device, for example, creates fractional wound patterns with zones of ablation or coagulation. These modalities are proven effective but can result in
inflammation, possibly leading to post-inflammatory hyper pigmentation (PIH), which is a major concern when dealing with aesthetic therapies worldwide.”

“With Dermapen we produce fractional patterns of similar microwounding with no ablation zone, no coagulation of capillaries or necrosis, and no denaturing of proteins,” Dr. Johnson elaborated.“Rather, the penetration of skin by sterile, surgical steel needles leads to apoptosis, which results in less inflammation but relatively equivalent neocollagenesis. In literature it has been shown that there is virtually no risk with microdermabrasion, and to my knowledge there is currently no reported case of PIH resulting from dermal needling,” he said.

“For fractional laser therapies the incidence of PIH can be as high as 30% in darker skin types,” Dr. Johnson stated.Also, the notably lesser inflammatory reaction seen with microneedle therapy correlates to the absence of dermal scarring, so there are many benefits of using microneedles to create dermal injury as opposed to energy-based fractional devices creating thermal injury.Re-epithelialization occurs within hours so there’s no downtime.” The excellent safety profile, lack of risk and downtime stem from Dermapen’s perpendicular puncturing method.

Furthermore, no skin type or body location is contraindicated for Dermapen, Dr. Sasaki shared, although the presence of disease conditions must be accounted for. “By nature Dermapen microneedle therapy is colorblind, meaning it can be used on any skin type. You may also safely use this device on areas where the skin seems paper-thin, such as the hand or inside of the arm. Contraindications are primarily disease related; you need to be careful of any active infections nearby because the technique is invasive, if only minimally so.”

Most importantly, users are seeing results.“As a stand-alone therapy I’ve seen very good outcomes with Dermapen for the upper and lower lip, acne scars, crepiness in the décolletage and inner arm, as well as overall skin rejuvenation,” said Dr. Sasaki. “We’re also exploring the use of Dermapen with other therapies such as light-emitting diode or intense pulsed light for a synergistic effect.”

Alex Kaplan, M.D.
Medical Director
Celebrity Laser Spa
Los Angeles, CA

Alex Kaplan, M.D., medical director of the Celebrity Laser Spa in Los Angeles, Calif., has been using Dermapen for most of 2012. “We use Dermapen primarily for acne scars, as well as hypertrophic and keloid scarring, especially where superficial discoloration isn’t a major issue,” he shared. While Dr. Kaplan had previously considered microneedle modalities, he wasn’t convinced until he discovered Dermapen.“Given the three-dimensional topography of the face, I was concerned with the variability in results from rollers due to pressure-related inconsistencies and the potential to overdo treatment. By design, Dermapen circumvents those concerns because it’s much more precise, controllable, simple and adjustable.You can provide very even treatment if you’re systematic in your approach.”

In one notable case, Dr. Kaplan recalled a young female patient presenting with hypertrophic scarring after incision and drainage of an abscess. “With her pigmentation the scar was noticeably wide, pink and raised, and she was very concerned about it,” he recalled. “With five or six Dermapen treatments the scar became much less noticeable. There is no obvious line of demarcation between the scar and surrounding skin, and it is much flatter now as well.”

Another major use of Dermapen, albeit off-label, is for transdermal delivery of drugs or PRP, Dr. Sasaki pointed out. “It is an obvious use of the device.Whenever we can generate openings of this nature in the skin we have an opportunity for topicals to penetrate more readily through the channels created.Non-biological materials such as cosmeceuticals or pharmaceuticals, or biological materials such as bioactive peptides of PRP, could be delivered in this way. You can use Dermapen to create the holes before or after applying the topical products.” In Dr. Sasaki’s experience, the window of product delivery is about 10 to 15 minutes, after which the channels will close. Furthermore, he is performing clinical trials to investigate this technique further.

David Mozersky, M.D.
Medical Director
ContourLase Body Institute
San Antonio, TX

David Mozersky, M.D., medical director of ContourLase Body Institute (San Antonio, Texas), has been using Dermapen for almost a year. He is among the
first to regularly employ it to enhance the delivery of PRP. “I have been interested in PRP rejuvenation for a while,” he began. “In my experience it works great but the injection process isn’t well tolerated by patients and it’s hard to encourage the kind of multiple-treatment regimen necessary for long-term results.Dermapen changed that for me.”

PRP involves the harvesting of blood from patients, which is centrifuged to separate the contents and concentrate platelets (and associated growth factors) by a factor of about 1,400, creating an autologous serum that both stimulates and enhances the body’s natural repair processes. “By introducing an extremely high concentration of the very compounds that upregulate and modulate wound healing, we stimulate and improve collagen growth for a healthier, more youthful appearance,” Dr. Mozersky explained. “By causing controlled micro-injuries safely with Dermapen, we can enhance the penetration of PRP without injection.”

Dr. Mozersky’s technique is simple and easy. “We add a chemical to activate PRP and then paint it on the treatment area. We then apply Dermapen, which not only creates the microperforations, but also drives in some of the PRP, achieving a great synergistic effect. We activate the PRP first to maximize the release of growth factors because the penetration is relatively superficial. Given the low cost, high patient tolerance, ease of use, safety and efficacy, Dermapen is a no-brainer. We don’t often see this combination of simplicity and efficacy in this profession.”

Paul Nassif, M.D.
Facial Plastic Surgeon
Beverly Hills, CA

In addition to regular use, facial plastic surgeon Paul Nassif, M.D. (Beverly Hills, Calif.), also delivers PRP with Dermapen.Like some of his colleagues, he delegates treatment to highly trained staff. “For rejuvenation, Dermapen microneedle therapy is fast, inexpensive, safe and effective but it’s an especially efficient method of delivering PRP. We can facilitate transmission of PRP growth factors with minimal trauma and rapid healing.” In his practice PRP is activated and applied, then Dermapen is used to create holes and punch the product into the skin.More PRP is applied, and the patient can go home after another hour or so. “In our practice we’re also trying it out for indications such as melasma; with a proprietary combination microdermabrasion technique that exfoliates, hydrates and nourishes skin; and with chemical peels.”

As an early adopter of the device in the U.S., Mark B. Taylor, M.D., of the Gateway Laser Center in Salt Lake City, Utah has had Dermapen in his practice for about 18 months.

“It’s so inexpensive and easy to use, giving real efficacy safely without the huge capital outlay normally associated with equipment. Plus, Dermapen fills a niche,” he said. Dr. Taylor delegates Dermapen to his highly experienced physician assistant and a nurse. “It’s easy and safe enough to use consistently.”

In his practice, Dr. Taylor uses Dermapen for the regular indications but also for drug delivery and in conjunction with numerous other therapies, especially as a superficial adjunct to deeper treatments or to enhance penetration of associated actives. “Remember, when delivering anything into the skin it is critical to avoid components that aren’t meant to penetrate. Some ingredients in a particular product or formulation may be fine with topical application but cause an adverse reaction if administered in a manner inconsistent with normal use, but many products, such as topical antioxidants, can be safely administered with the aid of Dermapen.”

Mark B. Taylor, M.D.
Gateway Laser Center
Salt Lake City, UT

Using Dermapen as a transdermal delivery facilitator has exciting potential to open up a wide-range of previously unavailable treatment options, in addition to enhancing currently available topically-applied therapies, Dr. Sasaki highlighted. “One must consider that traditional transdermal therapies require the molecules of applied material to be lipophyllic and tiny – approximately 500 Daltons in dimension – if one expects penetration through the intact stratum corneum. It is an inefficient mode of delivery highly dependent on the character of the individual’s skin as well.”

“With Dermapen we can create microchannels into the dermis, serving as conduits through which much larger molecules may pass,” Dr. Sasaki continued.“Other attempts at transdermal delivery exist but they cost a lot of money.The implications of this are staggering when you look at the variety of therapies that could be impacted by this simple, inexpensive technology.”

Emerging as a market leader, Dermapen LLC partnered with its companion firm Needlelogics to further educate the community about PCI and how to maximize its potential in practice.“We intend to provide a simple, reliable product that is 100% scientifically supported,” said Michael Morgan, CEO of Dermapen. “We are committed to providing unrivalled customer service and support to our clients.”
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