05-01-2011 - US Pivotal Study Proves Aquamid® Safety Profile Similar to Restylane over 12 Months Follow-up

A prospective, randomized, double-masked, multi-center, 2-arm clinical trial,  performed at 13 investigational centers around the US and consisting of 316 subjects, demonstrated that Aquamid® has an excellent safety profile through 12 months after treatment, which is similar to Restylane®, and showed no safety concerns to 24 Months follow-up. 

All subjects received injections of either Aquamid® or Restylane® for the correction of nasolabial folds. As expected for a soft tissue facial filler, the most frequently reported treatment-related adverse events during the first 12 months of the study were bruising, edema, redness, and tenderness. The majority of the treatment-related adverse events - over 85% in both treatment arms - were considered mild and in general transient, with most of the events resolved within 3 days.  Adverse events from 12 to 24 months follow-up included only one serious treatment-related adverse event that resolved spontaneously.

“We are proud to present yet another proof of our product’s safety,” says Michael Peytz, CEO of Contura International, “which further reinforces the previously proven safety achieved in our European 5-years clinical study, as well as the decade of experience of satisfied physicians and patients.”

No cases of allergy, granulomas or hypersensitivity were reported during the pivotal or extended follow-up phase of the clinical trial.  Adverse events related to the treatment were mainly bruising and edema for both Aquamid® and Restylane® treatment groups, further showing the equivalent safety profiles. 

In addition to the impressive safety profile demonstrated in the study, Aquamid® was found to be non-inferior in effectiveness compared to Restylane during 6 months follow-up, and its durability of aesthetic effects was found to extend through 12 months follow-up. The visual evaluation by the subjects revealed a statistically significant difference between the two groups in perception of treatment effect 12 months after treatment, with significantly more subjects treated with Aquamid rating themselves as improved than those treated with Restylane (88% vs. 76%). The durability of the Aquamid aesthetic effect was further maintained at 24 months; Aesthetic improvement assessments made by Masked Evaluators, Non-Masked Treatment Administrators, and subjects were overwhelmingly positive and preserved through 24 months.