In medical aesthetics, transdermal devices, or penetration enhancers, that use microneedles, rollers, dermoelectroporation and other novel modalities offer practitioners an efficient and minimally invasive technique to penetrate the skin barrier. But while practitioners have eagerly embraced these products and devices, few therapeutic or regulatory standards exist.
Physicians initially used these systems for skin rejuvenation procedures; however, after years of refinement, the devices now address many indications, such as acne scars and other scar types, hair loss, cellulite, fine lines and wrinkles, pigmentary problems, axillary hyperhidrosis, actinic keratosis in photodamaged skin, skin tightening and more.
These technology improvements have established microneedling as the predominant transdermal delivery method in most aesthetic practices. In addition, practitioners combine transdermal delivery technologies with surgical and nonsurgical procedures to enhance results.
Microneedling introduces a controlled wound into the skin, improving the ability to deliver drugs, sera and energies (radiofrequency, ultrasound, laser and CO2) across the skin barrier, bypassing the stratum corneum, into the vascularized dermis.
Treatments, especially with automated devices, have therefore become quite popular, having been anecdotally shown to be quite safe and providing exceptional results.
“Anecdotal” is the guiding word here though, as there are only a few FDA-approved devices on the market and hardly any high-quality clinical studies have been published when it comes to microneedling. In addition, some manufacturers have been notoriously deceptive in the marketing of devices and procedures in this genre, at times relying on misleading terminology, such as so-called infusion techniques, resulting in a kind of “Wild West” feel to the product category as a whole.
“The trend in this market is that people think microneedling and transdermal methods are the holy grail,” stated Michael Gold, M.D., dermatologist and cosmetic surgeon, and founder of Gold Skin Care Center in Nashville, Tenn.
“Any hole you put in the skin can be used for drug delivery,” he began. “For instance, when we treat hypertrophic scars, if we’re able to put drugs in after a fractional injury, or during skin treatments with a needling device of any kind, we are putting something sterile into the skin. These types of procedures can provide a definite benefit, in my experience. But while early clinical data suggests that these treatments may help, we don’t have any definitive data yet.”
According to Garry Lee, M.D., an aesthetic specialist in Las Vegas, Nev., “We are seeing an increase in patients seeking nonsurgical cosmetic treatments with less downtime and cost than plastic surgery. Microneedling adds value to those procedures. There is a saying in the industry that microneedling is the ‘poor man’s laser,’ which is emphatically true since the results can be dramatic for skin rejuvenation at a fraction of the price of most laser systems.”
Radiofrequency (RF)-based microneedling and other transdermal systems that utilize energy have emerged as a top choice among practitioners, noted Edward M. Zimmerman, M.D., a cosmetic surgeon in Las Vegas, Nev.
“While RF microneedling has become a trend regardless of what system you use, that and topical RF may have reached its apex in terms of what we can actually do with it,” he stated. “Even if we make the electrodes bigger so we can get a little bit more depth out of a monopolar system, it is a transient improvement in the appearance of skin texture and tightness.”
Advanced microneedling platforms are starting to appear in the marketplace, which go far beyond the earlier monopolar, unipolar and bipolar approaches.
For instance, the big box Vivace system from Aesthetics Biomedical (Phoenix, Ariz.) operates with 36 insulated, gold-tip needles and a robotic step motor that creates fast and even insertions into the skin. The robotic depth settings offer 31 precise, multilevel adjustments down to an exact depth of 3.5 mm at 0.1 mm increments. In addition, the system’s RF-based energy delivers heat evenly as it performs skin tightening, while reducing redness, hot spots, burning and patient discomfort.
Such advanced microneedling devices have benefited from improved motors, expressed Farhan Taghizadeh, M.D., medical director at Arizona Facial Plastics (Scottsdale and Phoenix, Ariz.).
“The advantage of superior motors is that you can create finer channels with better control,” he expressed. “By accelerating the motors on these devices, they are able to stamp very rapidly. It used to be you could only do a little bit of stamping, but now you have almost machine-gun accuracy with very rapid techniques that allow you to cover larger surface areas.”
Another cutting-edge variation on traditional RF-based technology is available in the Secret RF from Cutera, Inc. (Brisbane, Calif.). This system induces dermal remodeling by applying precisely controlled RF energy directly into various depths of skin from 0.5 mm to 3.5 mm via minimally invasive microneedles, sparing the epidermis and reducing patient downtime. Its dual handpieces and two treatment tip sizes (25- and 64-pin) allow physicians to treat patients quickly and efficiently in under 20 minutes.
According to Dr. Zimmerman, the evolution of microneedling will rely on combination therapies. “For instance, combining microneedling with plasma resurfacing, to achieve better neck tightening,” he indicated. “I’ve used helium plasma under the subdermal and added RF microneedling to the top and observed a pretty profound tightening effect. While plasma energy probably doesn’t go very deep, you might be able to go deeper with RF microneedling and get some of the subdermal tissue to contract, as well. We’re not just tightening the subdermal, but also tightening the fascial covering and the interstitial bonds between the dermis and fascia, which pulls tissue tighter.”
The combination of nonsurgical off-label procedures, which includes microneedling, can create synergy for better overall results, reported Dr. Lee. “Microneedling and platelet-rich plasma (PRP), for instance, are clearly one of the great combinations, albeit currently off-label, for skin rejuvenation and treating atrophic scars.”
PRP is often used as a transport medium for other materials, added Dr. Taghizadeh. And while PRP and platelet-poor plasma (PPP) have been established as valuable in transdermal delivery devices, “more recently we have started seeing advanced growth factors, amniotic products and umbilical stem cell products, which are better quality and beginning to supplant PRP.”
Other emerging product types utilize micronized horse collagen, which has no hypersensitivity to humans, as an adjunct therapy to devices.