- Lafullen's safety and efficacy proven in 24-month clinical study
- Improvements in initial volume and long-lasting effects
- Efficacious treatment protocol developed by specialists based on research results
SEOUL, South Korea, June 30, 2022 /PRNewswire/ -- Research results confirm the long-term safety and efficacy of Samyang Holdings Biopharmaceuticals Division's new filler Lafullen. A dermal filler is a proven safe medical device injected into the skin's subcutaneous fat layer to add volume and fill facial wrinkles for a smoother, more youthful appearance.
Samyang Holdings Biopharmaceuticals Division (CEO: Lee Young-Joon) announced on June 30th that a clinical study on the safety and improvement effect of its polycaprolactone (PCL) filler Lafullen has been published in the prestigious international academic journal Dermatologic Therapy, a Scientific Citation Index (SCI) publication that issues the latest scientific findings in the field of dermatology.
Professor Kim Beom Joon from the Department of Dermatology, Chung-Ang University Hospital conducted this comparative study of Lafullen and an existing PCL filler on 59 Korean men and women. The study examined Lafullen's effect on the nasolabial folds using a globally accepted standard index and confirmed initial volume improvement and safe and stable volume maintenance during the one-year course of the study.
Samyang Holdings Biopharmaceuticals Division has secured long-term safety and efficacy data by conducting follow-up observational studies for an additional 12 months after the study's conclusion to evaluate the expected duration of efficacy exceeding two years. Treatment protocols developed by medical professionals obtained quantitative data on improvements to nasolabial folds using the Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS) after treatment, and Volume change using a 3D scanner.
Development of Lafullen, an injectable dermal filler from Samyang Holdings Biopharmaceuticals Division, began in 2015 and received marketing approval from the Ministry of Food and Drug Safety in 2021. Lafullen is made of PCL (Polycaprolactone), a biodegradable polymer material for medical use, as its main component. Thanks to the patented technology of Samyang Holdings Biopharmaceuticals Division, Lafullen has less irritation compared to existing PCL fillers, and natural volume can be expected.
Sam Kim, Manager of Samyang Holdings Biopharmaceutical Division said, "Scientific research has confirmed Lafullen's duration of efficacy, safety, and stability." He added, "The study results are being used to refine the treatment protocol to ensure the highest standards of safety and efficacy for use by domestic and international dermatologists."
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