Formaderm Hyaluronic Acid Filler Demonstrates 70% Efficacy in Nasolabial Fold Treatment with High Safety Profile, Published in Journal of Dermatological Treatment

ShanghaiSeptember 28, 2023PR Newswire -- Recently, the internationally authoritative academic journal "Journal of Dermatological Treatment" published research data from the article "Safety and Efficacy of Hyaluronic Acid Injectable Fillers for the Treatment of Nasolabial Fold Wrinkles: A Randomized, Double-blind, Controlled Clinical Trial," co-authored by several experts and professors. This clinical study used the star product of Maxigen Biotech Inc., Fumedeng Sodium Hyaluronate Gel Filler (hereinafter referred to as Fumedeng Filler), as the research material to explore the safety and efficacy of this sodium hyaluronate gel filler.

Data show that the hyaluronic acid injectable filler has demonstrated excellent safety and efficacy, with low residual levels of 1,4-butanediol diglycidyl ether (BDDE), no cytotoxicity, good biocompatibility, and a 70% improvement rate in the Wrinkle Severity Rating Scale (WSRS). Additionally, in clinical applications, this filler has also exhibited better injection stability.

The journal "Journal of Dermatological Treatment," in which this research data was published, is a scientific journal ranked in the top 25% internationally in the field of dermatology. It focuses on publishing high-quality academic research articles that have undergone rigorous peer review, reflecting the latest advances, innovative technologies, and cutting-edge achievements in the field of dermatological medicine to promote scientific exchange and the transformation of research results in this field. In recent years, the journal's impact factor has been on a continuous upward trend and it has been indexed by the authoritative international database SCI.

To evaluate the efficacy and safety of Fumedeng filler in treating nasolabial fold wrinkles, a randomized, double-blind, controlled, non-inferiority single-center trial was commissioned at a landmark teaching hospital in Taipei. This trial included a total of 95 healthy participants receiving filler injections, with a safety follow-up period of 52 weeks and an efficacy evaluation period of 24 weeks. The primary efficacy endpoint was the WSRS improvement rate relative to baseline at week 24; secondary efficacy endpoints included the subjects' WSRS improvement scores and overall aesthetic improvement scale ratings. This trial has been registered on ClinicalTrials.gov, the world's largest clinical trials registry platform.

Final Study Data Shows High Efficacy and Safety of Fumedem Filler: 70% WSRS Treatment Success Rate at 24 Weeks with No Severe Adverse Reactions Reported. The study also analyzed BDDE residues and injection force in three phases. Regarding BDDE residues, data suggests that exposure to BDDE concentrations above the safety threshold of 2 ppm may cause irritation and allergic reactions. However, Fumedem filler showed BDDE residue levels <0.125 μg/mL, with an average of 0.11 ppm, reducing the risk of post-procedure adverse effects. Injection force testing demonstrated consistent and stable thrust using both 27G and 30G needles, indicating uniform HA gel distribution without aggregation or concentration. The product also exhibited low average protein content and no cytotoxicity.

芙媄登填充剂 as a key product under Maxigen Biotech Inc., is developed using the company's exclusively researched ECHA™ Equilibrium Crosslinking Technology. This technology unravels hyaluronic acid molecular chains through a specialized equilibrium device, evenly dispersing minimal doses of micron-level crosslinking agents around, resulting in a filler with uniform crosslinking, excellent viscoelasticity, and extrusion force.

In the future, Maxigen Biotech will continue to take "Humanistic Aesthetics, Scientific Aesthetics" as the direction of future ecological aesthetics, deepen its investment in the medical aesthetics industry, and focus on developing products and solutions that best meet the needs of beauty seekers, creating natural, harmonious, and healthy Oriental soft aesthetics for consumers in China.

Original Document Link:

https://www.tandfonline.com/doi/full/10.1080/09546634.2023.2190829?src=