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Unipolar RF energy provides a breakthrough in cellulite treatment, says the author of a recent study that also includes a new grading scale that could help physicians set realistic patient expectations.
Grapevine, Texas - A recently approved radiofrequency (RF) device (Accent, Alma Lasers) equipped with a unipolar handpiece represents the first meaningful breakthrough in the therapeutic battle against cellulite, says the physician whose study helped the device earn Food and Drug Administration approval for treating wrinkles.
"Until now, numerous treatment sessions were needed to observe improvement for cellulite," says Macrene Alexiades-Armenakas, M.D., Ph.D., assistant clinical professor of dermatology, Yale University School of Medicine.
To test safety and effectiveness of the device against cellulite, Dr. Alexiades-Armenakas and her colleagues used a randomized, blinded and internally controlled study design, which compared the device's performance on patients' treated legs to their untreated legs.
The study's design was ideal, because if one randomizes one treated patient against an untreated patient, "There's no control for inter-patient variability" in results of a given modality, she says.
Each patient received three to six treatments (mean: four) separated by two-week intervals. "In the device-based cellulite treatment arena," Dr. Alexiades-Armenakas says, "four treatments is a pretty small number" compared to the eight or 12 other modalities typically require. Treatments began at 150 to 200 W delivered for 30-second passes until skin reached a target temperature of 40 to 43 degrees Celsius. Investigators then delivered three 30-second maintenance passes at decrements of 10 W, moving the handpiece quickly to maintain temperatures.
To evaluate results, investigators took standardized photos at baseline and followed up at one and three months. Observers who analyzed photos "didn't even know what the study was for," Dr. Alexiades-Armenakas tells Dermatology Times.
However, she says they quickly discerned improvements in cellulite and graded them using a four-point scale devised by Dr. Alexiades-Armenakas. The scale incorporates measurements for the front and back of the leg, plus anterior and posterior views, along with dimple density, distribution and depth.
Based on blinded evaluators' scores, average anterior leg scores improved by around 8 percent, and posterior leg scores by 7 percent. "There doesn't seem to be a difference in how the anterior versus posterior leg responds," Dr. Alexiades-Armenakas says. Additionally, patients' mean overall improvement was 7.83 ± 3 percent.
Furthermore, she says she graded each patient's entire treated leg by combining mean scores for dimple density, distribution and depth, and compared this figure to similar scores for the control leg.
Overall improvement measured 8 percent" ± 2.8, Dr. Alexiades-Armenakas says. Therefore, she says that regardless of how full-leg scores were calculated, results were consistent.
Further analysis shows depth of dimpling proved most resistant to treatment, Dr. Alexiades-Armenakas adds. "It only decreased by 2.5 percent," she says, "so it seems as if the deepest dimples didn't become significantly more shallow. This signifies that most likely, it's the superficial dimpling that goes away first."