WASHINGTON -- A minimally invasive procedure for treating cellulite produced durable results that satisfied the vast majority of patients 3 years later, results of a small multicenter trial showed.
Clinicians rated 100% of patients as having "noticeable improvement" and 93% of patients said they were satisfied or very satisfied with results of tissue stabilized-guided subcision at the 3-year follow-up visit.
Patients and investigators noticed improvement soon after a procedure, and results appeared to improve over time in many cases, Michael Kaminer, MD, of the Yale School of Medicine in New Haven, Conn., reported at the American Academy of Dermatology (AAD) meeting.
"A 93% patient satisfaction rate for a device sort of meets the criteria that I think many of us would consider as something that our patients would accept, and that's the key," Kaminer said.
Developed several decades ago as a treatment for acne scars, subdermal undermining, or subcision, has been adapted for use in ameliorating the appearance of cellulite on the buttocks and upper legs.
The procedure targets one of the two main underlying theories of cellulite formation, Kaminer said. One theory posits that cellulite arises from fat accumulation. The other emphasizes the role of subdermal collagen cords that constrict and pull down areas of the dermis to create a dimpled appearance on the skin surface.
Placed on the skin surface over the area to be treated, the subcision device clicks into place over the treatment area, draws tissue inside a trap or chamber, and stabilizes the treatment area. Local anesthesia is administrated by means of an attached multibore catheter. The anesthesia apparatus is removed and replaced with a motorized module that includes a small reciprocating blade that cuts the collagen cords to release the retracted tissue, which migrates upward to fill and smooth out dimples.
"If we can cut the cords and the cellulite goes away, that's pretty good evidence that the cord was the cause of cellulite and not the fat; and that's what we've done," Kaminer said.
The subcision device, known by the trade name Cellfina, received FDA approval 2 years ago, but was introduced into the U.S. market just last year, he said. Published results of a pivotal trial in the U.S. demonstrated the safety and efficacy of the device and procedure, including durable results through 2 years of follow-up.
The trial involved 55 patients, 45 of whom were included in the 3-year follow-up analysis. Investigators enrolled women, ages 18 to 55, with moderate to severe cellulite and a body mass index (BMI) less than 35 kg/m2. The study population had a mean age of 40.7 and a mean BMI of 25.2 kg/m2 (range 18.6 to 34.6 kg/m2). Following administration of local anesthesia and a 10 to 15-minute dwell time, investigators performed a single treatment.
Follow-up visits occurred at 3 and 14 days; 1, 3, and 6 months; and then annually for 3 years. Results were assessed by the Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and patient self-reported satisfaction. Blinded reviewers evaluated "before" and "after" photos of treated areas, and investigators also rated treatment outcomes. The primary endpoint was ≥1.0 improvement on the CSS.
The study population had a mean baseline CSS score of 3.4, which decreased to 1.3 at the 3-month follow-up visit and was 1.4 at 1 and 2 years. The mean CSS score remained at 1.4 at the 3-year follow-up visit, Kaminer said. The proportion of patients with a minimum 1-point improvement in CSS score was 93% at 3 months and 91% at 3 years.
The blinded observers correctly identified the "after" photo in 97% of cases, consistent with results going back to the 3-month follow-up visit. Participating investigators found "noticeable improvement" in the GAIS scores of all patients at 1, 2, and 3 years and rated the degree of GAIS improvement as "marked" in 56% of the patients (down from 75% at 3 months and 72% at 1 year).
Of the 45 patients included in the 3-year analysis, 23 said they were satisfied with the results, 19 were satisfied, and the remaining three were neutral, resulting in an overall satisfaction rate of 93% for evaluable patients.
No serious adverse events occurred. Kaminer said about half the patients required nonprescription analgesics for an average of 1.5 days after the procedure. Minor bruising and redness in the treatment area occurred in many patients but dissipated quickly. Most patients have transient areas of firmness in the treated area. Two patients had palpable areas of firmness that persisted for 1 year but had disappeared by the 2-year follow-up.
The results with the device have been impressive, particularly the durability of the effects, said Sandy Sharon Tsao, MD, of Massachusetts General Hospital in Boston, who moderated the AAD session that included Kaminer's presentation.
But having undergone training to use the device, Tsao characterized the learning curve as "tricky." In contrast, Kaminer said operators have had little trouble mastering the device.
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