Sunday, October 28, 2007
13486

Assessment of Acute Safety at 2 Weeks in Subjects Injected Implanted with Hyaluronic Acid Gel Dermal Fillers

Jeffrey Dover, MD, FRCPC and Mark Rubin, MD.

Purpose: This study assessed acute safety profiles at 2 weeks among participants in clinical study evaluating the safety and efficacy of the hyaluronic acid gel dermal fillers, Perlane® and Restylane®. Methodology: A 24-week randomized, comparative, blinded-patient and blinded-photographic evaluator, baseline-controlled clinical study was conducted to assess the safety, immunogenicity, and efficacy Perlane® and to expand upon the available data about the safety, immunogenicity, and efficacy of Restylane®. Acute safety assessments were based upon local adverse experiences that occurred in the two weeks following the first injection. Acute safety data were acquired from two sources: patient diaries and investigator evaluation. Patients were specifically asked to respond to the existence (e.g., “none”) of bruising, redness, swelling, pain, tenderness, itching and mass formation (abscess, cyst or nodule) and, if so, their extent (tolerable, affects daily activities, disabling). Investigators evaluated adverse experiences at 72 hours and 2 weeks after initial injection through observation and patient interviews (independent of diary content). Results: 282 subjects (Restylane®, n=142; Perlane®, n=141) were evaluated over the full study period; 1 was lost to follow-up. Demographic and baseline characteristics were similar in both groups. Investigators classified most acute adverse local reactions as mild; none of the investigators rated any acute local reaction as severe. Investigator identification of acute local reactions included short-lived ecchymosis, edema, erythema, tenderness or pain, and, occasionally, itching; most had resolved in two weeks. Over the acute 2 week period, patient diary complaints included bruising, redness, swelling, tenderness, and pain; itching was less common. Most patient complaints occurred within the first three days after implantation, before the first investigator visit. The majority of complaints were classified as tolerable by most patients. The mean duration of the local adverse experiences varied from 2 to 5 days; the majority resolved before the end of the diary period. There was no clinically-meaningful difference in severity, type, duration, or onset of adverse experiences between Perlane® and Restylane®. Conclusions: The acute safety profiles of Perlane® and Restylane® were the same. Acute safety reactions were primarily mild-to-moderate and short-lived; the majority resolved within two weeks. There were no unexpected acute local reactions.