Advanced Aesthetic Technologies, Inc., a leader in aesthetic gel implant technology, has announced 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.ADVERTISEMENT
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.”ADVERTISEMENT
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.
References
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.13962