- Skin tightening seen with Pelleve is achieved without use of anesthesia.
- Results can last up to two years, depending on how fast patients' natural collagen breaks down.
PUNTA GORDA, FLA. A recently FDA-approved device called Pelleve™ (Ellman International, Inc.), which employs high radiofrequency (RF) technology for nonablative skin tightening and facial rejuvenation, has demonstrated some effect in the treatment of mild to moderate wrinkles and rhytids. And some of the physicians who have utilized it tell
Cosmetic Surgery Times
that it offers some key advantages over other currently available RF devices.
First, the skin tightening seen with the Pelleve system is achieved without the use of any anesthesia. According to Kai Rezai, M.D., a dermatologist from Muenster, Germany, anesthesia is not only unnecessary during the procedure, but is actually contraindicated due to the nature of the treatment approach. Instead, when performing the procedure, the patient is required to provide feedback to the physician and signal when the target area is getting hot. The heat threshold level is typically around 42 degrees centigrade. This target temperature at the skin's surface can vary one or two degrees, but it correlates to about 20 degrees higher at the dermal-subdermal junction.
IT'S THE PATIENT'S CALL "Feedback from the patient is very important as it serves to avoid overheating the dermis," Michael Stampar, D.O., a board-certified ENT and facial plastic surgeon, Punta Gorda, Fla., explains. "Patients are strictly instructed not to be 'brave,' but to be honest with the sensation of heat they are feeling as a hotter target area is not synonymous with a better cosmetic result. As an 'insurance,' we also employ infrared temperature monitoring during the procedure to determine and verify that the patient responds within a degree or two of the target heating temperature." In a recent clinical trial, 93 participants with mild to moderate wrinkles and rhytids were given a single treatment with Pelleve without any use of skin-cooling products or local anesthetics. Results showed that more than 87 percent of patients demonstrated measurable and immediate positive cosmetic outcomes in a blinded assessment of skin laxity and wrinkle improvement — with a continued response six months after treatment.
DUAL WAVE EFFECT The high frequency radiowaves have a two-pronged effect. First, they induce a denaturization and subsequent contraction of the collagen fibers in the target area; secondly, they cause micro-scarring in the dermis, proven by histology. These micro-scars produce fibroblasts, which, in turn, lead to neocollagenesis. Macroscopically, a tightening can be seen immediately following the procedure, but this tightening continues to improve over two to three months as new collagen forms, say the physicians who have utilized the device, resulting in thicker, plumper skin. "If you injure the dermis to that degree, you trigger enough of an injury to trigger that healing response that lays down new collagen," Dr. Rezai explains. "If you do not get to that threshold, you will not help the patient, and if you get to that threshold too fast, you may cause pain and even burn the targeted area."
This 56-year-old female patient is show before (left) and (right) immediately following one treatment with the newly FDA-approved RF device, Pelleve. (Photo credit: Kai Rezai, M.D.)
Depending on the severity of the wrinkles and rhytids, Dr. Rezai notes that although the cosmetic effect of Pelleve can be seen after the first treatment, usually the patient will receive two to three treatments. Results can last for up to two years, depending upon how fast patients' natural collagen breaks down, with maintenance treatments indicated every one or two years.