Cellfina Announces Unprecedented 5-Year Results for Treatment of Cellulite
By Carolyn Hsu |
Cellulite, the dimpled skin that forms when fat pushes through connective tissue, happens to almost all women. Studies show that anywhere from 90 to 95 percent of women, regardless of age, body type and skin color, experience it to some degree. For decades, treatment for cellulite have been met with mixed—and mostly, short-term—results. So, in 2015 when Cellfina, a clinically proven, minimally invasive procedure, was FDA-cleared for improving cellulite for up to two years, it proved to be a game-changer. Just a year later, the FDA cleared Cellfina to deliver results that last for up to three years.
But new research announced at ASDS today show that procedure is effective at delivering even longer-term results. A new study that enrolled 55 women who underwent a single treatment shows that 100 percent of subjects still had noticeable improvement five years after treatment, and 78 percent of subjects reported as being satisfied or very satisfied with their results at the five-year mark.
“The Cellfina procedure treats the underlying cause of cellulite dimples in the buttocks and thigh areas by releasing the tethered fibrous septae bands. It treats the structural cause of cellulite dimples, not the symptom,” explains Kristina Yu-Isenberg, vice president of North America Medical Affairs at Merz.
“The Cellfina five-year data is unparalleled in the history of cellulite research,” says Boston dermatologist and Cellfina five-year study group member, Michael Kaminer, MD. “That might sound like a hype, but it is statistically accurate. Never before has a cellulite treatment been shown to produce noticeable, long lasting efficacy at five years in essentially 100 percent of patients. Until Cellfina, nothing else lasted more than nine to 12 months. And most cellulite treatments produced very mild improvement lasting at most eight to 12 weeks.”
Research subjects underwent a single treatment and were followed at regular intervals out to five years. Safety was assessed and effectiveness was evaluated by blinded, independent physician evaluators using randomized (before/after) professional photographs.
Improvement of cellulite was measured on a six-point scale, based on the pre-treatment combination of number and depth of cellulite dimples. “The goal of the study was to achieve a one-point improvement for FDA clearance, but we were delighted to see that patients achieved a two-point improvement on average. That means they had twice the statistical endpoint we were looking for in terms of improvement,” explains Dr. Kaminer.
“One is longevity of results at five years, which is unprecedented in cellulite treatment,” says Dr. Kaminer. “In fact, many people thought it couldn’t be done 100 percent of patients at five years still had noticeable results. That’s impressive for any minimally invasive procedure.”