LAS VEGAS Porcine collagen crosslinked with D-ribose probably lasts as long or longer than does hyaluronic acid when used as a cosmetic filler for lips and nasolabial folds, Dr. Gary Monheit said at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.
The product, Evolence (Dermicol-P35) manufactured by ColBar LifeScience Ltd. (Israel), is approved for use in Europe and Canada and is expected to be approved in the United States, according to Dr. Monheit, principal investigator in the U.S. trial. The company has submitted an approval application to the Food and Drug Administration.
The trial's split-face design compared Evolence injection with hyaluronic acid (Restylane) injection in the nasolabial folds of 149 patients. After 6 months, there was no significant difference in the mean amount of correction the patients had on either side, as judged by study observers using the Modified Fitzpatrick Wrinkle Scale score (Dermatol. Surg. 2007;33:S21321). Dr. Monheit disclosed receiving supplies and financial support from ColBar.
The secret to Evolence's longevity is thought to be the high level of crosslinking between the individual collagen fibers in the material, he said. "Because of this extra crosslinking, this is a very stable product that lasts over a year, possibly 2 years."
At 1-year follow-up, 90% of the patients that received Evolence still had some degree of improvement, said Dr. Monheit of the University of Alabama, Tuscaloosa. Evolence has been found to last up to 2 years when implanted into rabbit ears.
Raw material for Evolence comes from the tendons of pigs. In the first step of processing, the pig collagen's natural crosslinking is broken down by pepsin into monomeric collagen. Then the telopeptide of each collagen strand is removed because that part is the most immunogenic.
Pig collagen is used by ColBar because it is probably less immunogenic than beef collagen, he said.
Once the telopeptides are removed the material is again crosslinked, but instead of using glutaraldehyde or some other potentially problematic chemical to create the crosslinking, ColBar uses D-ribose, Dr. Monheit said.