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A new collagen implant safely and effectively corrects nasolabial folds for up to a year, according to a pivotal trial.
San Antonio - A new collagen implant with a unique form of cross-linking provides safe, effective correction of nasolabial folds (NLFs) for up to a year, according to a pivotal trial. As a result, Food and Drug Administration (FDA) approval of the product is imminent, one of the trial's investigators says.
For the 12-month safety and persistency trial, researchers recruited 149 subjects whose nasolabial wrinkles covered at least 50 percent of the nasolabial area and qualified as Class 2 or greater using the validated Modified Fitzpatrick Wrinkle Scale (MFWS).
The collagen is cross-linked with a sugar, ribose. "That makes it unique because it's cross-linked with a natural substance rather than glutaraldehyde, which collagen fillers typically use for cross-linking, although its toxicity at certain levels may limit the concentrations physicians can use," he says.
"Because ribose is a naturally occurring sugar," Dr. Lorenc says, "it mimics what happens in the body when collagen is being rebuilt. Because of that, there's also no limit on the concentration of the cross-linking agent, which increases the filler's persistence."
Optimal cosmetic result
Investigators considered a study patient's treatment complete when the patient achieved an optimal cosmetic result (OCR), as determined by the treating investigator. Some patients got touch-up injections two weeks after their initial treatments in order to achieve an OCR.
"We followed patients with digital photography (Canfield) using a standardized format where the lighting, distance and head position remained constant throughout the study," Dr. Lorenc tells Dermatology Times.
Investigators also tracked adverse events through subject diaries and evaluation of injection sites, as well as laboratory test results.
Investigator assessments showed that the Glymatrix collagen provided significant correction at the OCR visit, and corrections persisted nine and 12 months later. More specifically, pretreatment scores averaged 2.38 (on a seven-point scale, indicating moderate to prominent NLFs), while the mean MFWS score at the OCR visit was 0.53.
During the follow-up period, mean MFWS scores for Glymatrix collagen-treated NLFs increased somewhat, but the mean MFWS score remained significantly lower (p<0.001) than the pretreatment value, Dr. Lorenc says. At the nine- and 12-month visits, the mean MFWS also represented a statistically significant increase from mean MFWS at the OCR visit.