Miriam E. Tucker

March 11, 2016

WASHINGTON, DC — A procedure to smooth cellulite by cutting the fibrous "cords" that pull the skin down is effective and safe, new 3-year data show.

And the study results confirm that fibrous septae is the source of most types of cellulite that pull down on the bottom of the skin, causing a cellulite dimple, said Michael Kaminer, MD, from the Departments of Dermatology at Yale University in New Haven, Connecticut, and Brown University in Providence, Rhode Island, who is a founding partner of SkinCare Physicians in Chestnut Hill, Massachusetts.

This has been debated in cosmetic dermatology circles, with some practitioners endorsing the theory that cellulite arises from fat underneath the skin pushing up on the dermis and causing the bothersome bumps.

But "if you can cut the cords and the cellulite goes away," it proves the fibrous septae theory, Dr Kaminer explained during in a late-breaking session here at the American Academy of Dermatology 74th Annual Meeting.

The technique, known as subcision, is performed with the Cellfina device, which is manufactured by Ulthera. The US Food and Drug Administration approved the noninvasive treatment in 2015 for improvement in the appearance of cellulite on the buttocks and thighs with no loss of benefit for up to 2 years.

"The data in the presentation support even longer efficacy," and there were no long-term adverse effects seen in the study, Dr Kaminer told Medscape Medical News.

The procedure is easy, he said, but it "is clearly technique-dependent, so physicians must learn about cellulite anatomy."

Cutting the Cords

The open-label, multicenter study involved 55 women, 87% of whom were white, with areas of moderate or severe cellulite on the buttocks or thighs. Mean age was 41 years, mean body mass index was 25.2 kg/m² (range, 18 - 35), and all five Fitzpatrick skin types were represented, although 46% were type III.

Each woman underwent a single treatment with the tissue-stabilized-guided subcision system. The clinician marks the area to be treated with a surgical pen, anesthetizes the area, and then applies the hand-held device, which is designed to provide vacuum-assisted control of the depth and area of the tissue release.

"You can customize the area of release to the millimeter," Dr Kaminer explained. "You don't have to go in like a blowtorch and undermine everything, you can undermine very precisely, literally 6 to 8 mm inside of a dimple."

About 20 to 30 individual cellulite dimples are treated during an average session, he reported.

In the 3-year study, an independent physician evaluated photographs taken before and after treatment.

At 3 years, the 45 patients remaining in the study had achieved an average reduction of 2.0 points on the 5-point Cellulite Severity Scale (P < .0001). That result was nearly equal to the 2.1-point reduction seen at 3 months.

And the rate of improvement in severity of at least one grade (none, mild, moderate, or severe) at 3 years was similar to that at 3 months (91% vs 93%).

The ability of blinded physician evaluators to distinguish before from after photos was also similar at 3 years and 3 months (97% vs 98%). Noticeable improvement on the Global Aesthetic Improvement Scale was actually better at 3 years than at 3 months (100% vs 98%).

"This is not subtle. It's a very, very noticeable improvement that is identifiable to a blinded physician. And it's in the overwhelming majority of patients we treat," said Dr Kaminer.

The rate of "marked" improvement on the Global Aesthetic Improvement Scale was lower at 3 years than at 3 months (56% vs 75%). But that's still a good result, according to Dr Kaminer. "A little over half of patients will have a result that's eye-popping," he pointed out.

Indeed, satisfaction scores were high at 3 years; 23 of the 45 patients (51%) reported being satisfied, and 19 (42%) reported being very satisfied. That 93% was a slight improvement over the 3-month 85% satisfaction result.

Rates of patient-reported pain were similar to those seen in the literature for injected toxins and fillers. Just over half the women reported pain, which lasted an average of 1.5 days and was treated with over-the-counter analgesics in all cases. By 6 months, all pain was gone.

There were no serious adverse events. One patient had a superficial wound from scratching at the treatment site, and another reported itching from the compression garment she wore, as recommended, after treatment.

Bruising at the treatment site affected most patients, but only five were still affected at 4 weeks, and palpable but nonvisible areas of firmness lasted longer than 6 months in only two patients. These expected treatment effects can be minimized with massage or steroid injections, if necessary, Dr Kaminer reported.

"We know that our patients are happy, and the good news is that it's been done for the most part with no long-term side effects," he added.

 
We really didn't have a lot of effective treatments for cellulite, and now we have one.
 

The data earned high praise from session moderator Sandy Sharon Tsao, MD, from the Massachusetts General Hospital in Boston. "For me, as a practicing dermatologist and laser cosmetic surgeon, this is a coup because we really didn't have a lot of effective treatments for cellulite, and now we have one."

Most other currently available cellulite treatments are temporary and provide minimal benefit, she pointed out.

"Having a 3-year study showing the benefits of a novel subcision treatment is incredible. The side effects, thankfully, were limited and short-lived. I think it really can provide improvement in cellulite," she explained.

Cellulite, although not life- or health-threatening, is still perceived as a major problem for many women, said Dr Tsao. In fact, in the cosmetic dermatology world, it's one of the top reasons people seek treatment.

"Many people don't realize the significance of cellulite on young women, who feel very self-conscious about that dimpling on the outer side of their legs," she said. "For some women, it's emotionally impairing."

This study was funded by Merz, the parent company of Ulthera. Dr Kaminer reports receiving honoraria and serving as a consultant for Merz, and having financial relationships with Cytrellis Biosystems, Miramar, Zeltiq, and Cutera. Dr Tsao has disclosed no relevant financial relationships.

American Academy of Dermatology (AAD) 74th Annual Meeting. Presented March 5, 2016.

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