SBU Researchers to Test New Cellulite Treatment

There currently are no Food and Drug Administration-approved treatments for cellulite problems, but a pair of Stony Brook University researchers have the potential to change that.

The School of Medicine's Dr. Marie A. Badalamente, a professor of orthopaedics, and Dr. Alexander B. Dagum, professor and chief of plastic and reconstructive surgery, are on the verge of beginning a placebo-controlled clinical trial on a drug that was developed at Stony Brook to treat cellulite problems, according to a Stony Brook Medicine announcement.

According to the doctors, about 90 percent of women and 10 percent of men have cellulite.

“While cellulite isn’t harmful, it is a serious cosmetic concern for many people who want to feel better about their appearance and who want to reduce cellulite as much as possible,” Dagum said. “There are many methods to remove cellulite but few have been supported in medical literature to be effective or potentially usable as a standard practice.” 

Badalamente said that current treatments, such as  laser therapy, massage treatments and topical creams, are limited in ability and not conclusively effective in the long-term.

"We are looking for a standard and safe method of treating cellulite and one that can be effective for a long period of time," she said.

The drug used is clostridial colleagenase histolyticum, which is an injectable form of the enzyme collagenase. The treatment method is licensed to Lynbrook-based BioSpecifics Technologies Corp. and is sublicensed to Pennsylvania-based Auxilium Pharmaceuticals, Inc. 

According to the researchers, cellulite is "the normal fat beneath the skin that pushes against connective tissue (collagen) anchoring strands, causing a dimpled effect on the skin above it." Their work on the injection is intended to break down the collagen that anchors the dimples, thereby evening out the skin irregularities the cellulite was causing. In 2006, the researchers piloted a clinical trial of 10 women at Stony Brook after obtaining a new FDA drug number for clostridial collagenase histolyticum. Following that study, patients reported feeling very satisfied with what appeared to be a 76 percent reduction of cellulite six months after treatment.

"We believe that a significant reduction of cellulite after six months from an injection that appears to be well-tolerated is promising for patients and warrants continued testing within the FDA regulatory process," Badalamente said.