Results of Split-Face Study to Determine the Efficacy and Safety of 2.5% Agarose Gel Filler for the Correction of Nasolabial Folds Published in Peer Reviewed Journal
BROOKLINE, Mass., May 25, 2021 /PRNewswire/ — Advanced Aesthetic Technologies, Inc. (AAT), a leader in aesthetic gel implant technology, is proud to announce that Algeness® VL (2.5% Agarose Gel) demonstrated equivalent efficacy, safety, and usability compared to those of NASHA-L based on a split-face study published in the Journal of Cosmetic Dermatology.
“Agarose gel filler is a naturally occurring polymer gel with a three-dimensional structure similar to the extracellular matrix, which achieves its duration without the need for crosslinking. Our objective with this study of 66 patients was to determine the efficacy and safety of 2.5% agarose gel filler for the correction of nasolabial folds as compared with NASHA-L. Our assessments included assessment of the nasolabial fold (NLF), Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS [blinded investigator]), as well as subject satisfaction, adverse events, and usability,” according to lead investigator Nicolò Scuderi MD of the Department of General and Plastic Surgery at the University of La Sapienza, Rome, Italy.
Among the 66 participants in the study, 46 individuals or 66.7% were available for evaluation at 3 months, when mean change in WSRS was identical for both products (−1.1 ± 0.4 for 2.5% agarose; −1.1 ± 0.4 for NASHA-L). Scores for each product remained similar across all time points and began to return to baseline between 7 and 8 months. GAIS score followed a similar pattern, rising between months 7 and 8 (2.7 ± 0.6 for 2.5% agarose at month 7 and 3.3 ± 0.5 at month 8, vs. 2.7 ± 0.6 for NASHA-L at month 7-3.3 ± 0.5 at month 8). The longevity of both fillers was confirmed by Ultrasound. All adverse events were transient in nature and resolved within 15 days, most events were mild in nature, and the number and severity of events was similar between the two fillers. According to Dr. Scuderi, “We continue to be impressed with the clinical outcomes of the novel Algeness® range of dermal fillers. This is the first 100% natural, biocompatible and biodegradable filler on the market to date, which differentiates it from other injectable products.”
U.S. based investigator Brian Kinney, MD, FACS, Division of Plastic Surgery, University of Southern California, Keck School of Medicine, in Beverly Hills, CA, adds, “These results add to the growing body of evidence that confirms that Algeness® (2.5% agarose gel filler) has a high safety profile and is well tolerated by patients. We concluded that this unique dermal filler compound had a longevity which was equivalent to one of the most widely used fillers, NASHA-L a hyaluronic acid.”
Doug Abel, CEO of AAT commented, “We are very pleased with the outcome of this important study which demonstrate that in this initial clinical study, the results with 2.5% agarose gel are equivalent to those of NASHA-L. This is another significant milestone demonstrating the efficacy and performance of our proprietary Algeness® technology. This notable recognition from three internationally respected plastic surgeons reconfirms the durability of the Algeness® technology and secures its place as a differentiator in the global dermal filler market. We have begun the process to pursue both US FDA approval for Algeness® and, through our strategic Partner, registration in China.”
Algeness® is a patented family of fully resorbable injectable gel implant dermal fillers that are 100% natural, providing advantages in terms of safety, skin rejuvenation, and natural looking results both at rest and during facial movement. Typical clinical advantages include minimal swelling upon injection and immediately visible results. Algeness® holds a CE Mark and is currently distributed in over 30 countries worldwide.
About Advanced Aesthetic Technologies, Inc.
AAT is a fast growing, global corporation developing new technologies for aesthetic medicine. Our lead products, the Algeness® family of injectable implants, are the culmination of more than 10 years of scientific and clinical research and were developed with the goal of providing aesthetic injectors advances in the ability to achieve deep structural support, clean definition, and exceptional clinical outcomes where the result at the time of treatment is the final outcome. Algeness® is a 100% natural and biodegradable filler based on purified agarose with a differentiated clinical and safety performance profile. AAT continuously invests in research and product development to expand the scientific knowledge on Algeness® and agarose as well as in pursuit of new and innovative technologies to enhance aesthetic medicine and expand our portfolio. Algeness® is CE Marked, has multiple additional country level registrations, and is currently available in over 30 countries. AAT is in the process of pursuing registration in the US through the FDA and also in China through the partnership with Lanzhou Biotechnique Development Co., LTD (Lanzhou) and their parent company China National Biotec Group Co., LTD (CNBG). http://www.algeness.com
Scuderi N, Fanelli B, Fino P, Kinney BM. Comparison of 2.5% agarose gel vs hyaluronic acid filler, for the correction of moderate to severe nasolabial folds. J Cosmet Dermatol. 2021;00:1– 8. https://doi.org/10.1111/jocd.