Reliant Technologies (Mountain View, California), which focuses on fractional resurfacing, presented first-phase results from a 230-patient multi-site clinical study of its new Fractional Deep Dermal Ablation (FDDA) treatment at the 27th American Society for Laser Medicine and Surgery (ASLMS; Wausau, Wisconsin) Annual Conference held last week in Grapevine, Texas.
The trial is evaluating FDDA treatment for patients with severe photodamage including rhytids, skin laxity, acne scars, atrophic scars, vascular lesions and striae. The first-round results, conducted using the first prototypes of Reliant's Fraxel re:pair system, demonstrate that FDDA treatment is safe and effective without the extended recovery time and risks of adverse reactions associated with conventional ablative resurfacing lasers (also known as CO2 or erbium YAG lasers), the company said.
The company says that FDDA treatment combines the benefits of conventional CO2 resurfacing with the safety of fractional photothermolysis. In contrast to conventional bulk ablative laser skin resurfacing where 100% of the epidermis is ablated, leaving only superficially coagulated dermis, the Fraxel re:pair system treats to depths exceeding 1.6 mm.
"Patients are often wary of CO2 lasers and surgical procedures because the post-treatment healing process can last as long as two weeks and disrupt their quality of life," said Zakia Rahman, MD, clinical instructor of dermatology at Stanford University (Palo Alto, California) and medical director of the Fraxel Laser Clinic.
Rahman presented the first round results of a 30-patient study from three investigational sites, which examined FDDA treatment for patients with severe photodamage, including rhytids and skin laxity.
Heather MacFalls, director of regulatory affairs and clinical research for Reliant, told Medical Device Daily that the "main deterrent to traditional CO2 resurfacing is the risk for side effects, particularly more serious complications. Our aim is to introduce a modality that is not associated with those risks," while still matching the efficacy of traditional C02 resurfacing.
Reliant has clearance for two Fraxel devices, but clearance specifically for the Fraxel re:pair is pending, she said.
The results demonstrate that patients treated with the prototype Fraxel re:pair system sustained significant improvements through the final follow-up visit. More than 75% of patients experienced improved appearance of rhytids, or wrinkles, and pigmentation as well as skin laxity, while no adverse effects were observed, the company said.
"The ability to uniformly remove deep dermal tissue constitutes an entirely new paradigm," the company said.
The Fraxel re:pair system induces ablation, followed by tissue contraction, tightening and collagen remodeling. The result is a multi-dimensional approach for treatment of photodamage which relies on a broader range of mechanisms than those employed with surgical procedures.
In other conference news:
A more energetic version of the ultrasound technology used to image babies in the womb is now being touted in cosmetic dermatology to lift and tighten skin tissue of the forehead, neck and cheeks, according to research presented at the meeting.
Murad Alam, MD, assistant professor of dermatology, otolaryngology and surgery at Northwestern University (Chicago), reported on a study of 36 patients which showed that transcutaneous ultrasound technology can safely penetrate deeper into the skin than lasers and other light sources to produce noticeable skin tightening.
"The ultrasound technology we studied is a different type of energy than previously used because of its ability to precisely penetrate deeper into the skin and bypass superficial skin layers without damaging surrounding tissue," said Alam. "It's also versatile enough to use on most facial areas, including the neck where the skin is thinner and more difficult to treat."
Relying on high-intensity sound waves, the technology specifically targets the fat layer under the skin of the face and possibly the superficial muscolo aponeurotic system (SMAS), a thin layer of muscle fibers that sags with age.
The deeper skin structures are the areas the machine also targets with a series of "super-fast" ultrasound vibrations, triggering wound healing and new collagen formation that shrink facial tissue.
Different handpieces are used depending on the depth where the ultrasound energy needs to be deposited to create the desired outcome. For example, the skin on the forehead and cheeks can tolerate more energy delivered at a greater depth, whereas the neck area is treated with a hand piece that delivers energy more superficially.
In this study, 36 patients were treated with ultrasound on the forehead for eyebrow elevation; on the neck and jowl area for skin tightening; and on the mid-face (cheek) area for softening wrinkles or nasolabial folds.
For brow lift treatments, before-and-after clinical photographs localizing the precise treatment area were used to assess improvement. Patients treated for neck tightening were evaluated by double-blinded raters from before-and-after photographs. A standardized, clinical classification system was also used to evaluate wrinkle reduction.
Alam reported that brow elevation of 1 mm-2 mm, or significant neck wrinkle reduction occurred in more than 75% of patients (29 patients).
"The beneficial change seen in the brow lift patients is clinically significant and resulted in a noticeable improvement that should appeal to patients bothered by a heavy or tired appearance in the eyebrow and eyelid area," said Alam. "In fact, the degree of improvement with the ultrasound technology is better than that obtained in clinical studies using other treatment modalities. Neck and jowl tightening was also consistently seen…. [W]hile no specific data is available for the cheeks, we did notice improvement in the mid-facial area — specifically a softening of wrinkles and nasolabial folds and a reduction in lines under the eye."
Alam added that most patients require only one to two treatments on average, and results begin to be evident within a few weeks of treatment and continue to improve up to three to six months. The out-patient procedure takes approximately 30 to 45 minutes.
Minor side effects such as redness and swelling occurred following the procedure but resolved quickly.
Alam said the treatment is not FDA approved but holds "tremendous potential in safely and effectively treating a number of age-related cosmetic concerns."
• Cynosure (Westford, Massachusetts) said that its newest aesthetic laser systems were the subject of nine technical and clinical presentations at the meeting.
Laser 2007 will include the presentation of analytical data from studies involving Cynosure's Affirm Anti-Aging Workstation, Smartlipo, LaserBodySculpting Workstation and Cynergy Vascular Workstation.
Michael Davin, president/CEO of Cynosure, said, "The key message for physicians and other medical professionals who attend the conference is that Cynosure is a leader not only in technology innovation but in working with them to help to profitably build their aesthetic laser practices."