A retrospective five-year safety and efficacy study of a new PMMA filler shows a low risk of adverse events and a trend toward continued improvement over the entire five-year follow-up period, says a researcher involved with the study.
San Antonio - In a recent five-year follow-up study, a new filler for nasolabial folds (NLFs) has achieved both a low rate of adverse events and continued improvement in NLFs throughout the five-year period, one of the study's investigators tells Dermatology Times.
However, the study also illustrates the need for effective long-term tracking of all cosmetic filler recipients, he says.
The Food and Drug Administration (FDA)-mandated follow-up study of ArteColl (polymethylmethacrylate/PMMA, now called ArteFill, Artes Medical) included 145 subjects evaluated for safety five years after treatment in the filler's pivotal FDA study.
Conversely, Dr. Rullan says that in the eight years he's been using the PMMA filler, "I've never seen an inflammatory reaction of any kind in an ArteColl or ArteFill patient."
Furthermore, he says that because no biopsy was done on either nodule, "We can't really call it granuloma."
Dr. Rullan says that in his own study patients, the only adverse event that occurred was a small linear ridge along one patient's NLF that appeared because he injected an earlier, stiffer, German-made version of ArteColl too superficially.
This ridge has remained unchanged for five years, he says, "And we will now correct it with an intralesional steroid injection or light abrasion. New injectors will need mentoring to ensure correct placement of the filler."
Overall, 20 treatment-related adverse events occurred in 15 subjects, and investigators considered 14 of these events mild.
The most commonly noted adverse event overall was lumpiness of the implant, of which 10 cases occurred (eight mild, one moderate, one severe).
Subjects also experienced redness and bruising fairly commonly, Dr. Rullan says, but he attributes these problems to poor study design requiring touchup treatments to be performed only two weeks after a patient's previous treatment.
Also striking was the fact that results tended to improve from six months post-treatment until the study's end, Dr. Rullan says.
In blinded observers' assessments, patients' photometric Facial Fold Assessment (FFA: 0=none, 5=severe) scores improved by 0.71 points six months after treatment and by 1.01 (p<0.002) points at five years.
Even patients whom investigators considered to be low responders (<0.8 FFA improvement at six months) showed significant improvement when investigators compared six-month results to those at five years.
Similarly, investigator-evaluated FFA scores showed improvement of 1.67 points, five years post-treatment (p<0.001). Ninety percent of both patients and investigators expressed complete satisfaction with treatment at five years.
At the study's conclusion, Dr. Rullan says, "No one looked worse than before treatment. So they hadn't visibly aged. And some actually improved" over the results they achieved 12 months after treatment.
"At that point," he says, "one realizes that this is a different kind of filler that's never been used before, and that maybe the potential risks are worth it to some people."
Dr. Rullan says the serial puncture technique, which he now favors, produces less bruising than the traditional tunneling technique, or injecting filler in lines parallel to the NLF as one withdraws the syringe.
"What I'm doing now, which is more consistent and may be an easier technique for many doctors, is to inject it as we do Restylane," he says.