Background

It is known that the medical aesthetics industry is experiencing unprecedented growth. Singclean Medical is expanding its layout from hyaluronic acid HA to regenerative materials such as PDRN, CaHA, PLLA, etc, Singclean is also actively conductinc clinical trials in the hope of launching them on the market at an early date, and bringing more safe and efficient medical aesthetic products to immediate and future patients.

Objective

To evaluate effectiveness and safety of Singderm® Poly L-lactic acid injectable filler through 12 months clinical trial in improving nasolabial folds. 

Introduction 

PLLA, a biostimulator, can activate skin fibroblasts and promote type I and type III collagen regeneration mainly through immune inflammatory response, thereby improving skin texture, reducing nasolabial folds wrinkles, and increasing skin firmness and elasticity. After injection, There is minimal infiltration of inflammatory cells around the implant. circular granular filler particles are observed in the deep layers of the dermis, surrounded by a small number of fibroblast cells, indicating the generation of new collagen.  

Method 

The subjects in this research experiment were 95, all within the age range of 25-65 years with Grade 3-4 level on the WSRS（Wrinkle Severity Rating System). The interval between each treatment was 28 ± 5 days. PLLA stimulates obviously collagen production and improves the appearance of nasolabial folds.  

Results 

The efficacy is expected to be 92%. During clinical trial, 59 Subiects completed 3 injections and among them, 50 subjectsimproved their nasolabial fold scores by at least one grade. Apparently, they have reduced nasolabial folds. Due to thenature of PLLA products, it takes time to stimulate collagen in the underlying layers of the skin.

Compared with control group, more fibroblast cells can be seen around the round granular PLLA filler in the deep dermis of the skin for Test Group, indicating the generation of new collagen. Some collagen appears coarse, enveloping the implant. There is less infiltration of inflammatory cells around the implant.

Conclusion 

In this clinical study, subjects showed significant improvement in the shape and appearance of the nasolabial folds after injection of Singderm® PLLA. The study was not completed with all follow-up, but it was enough to prove the effectiveness and safety of this regenerative filler.

Singclean will focus on the European regenerative medical aesthetics market and conduct more clinical trials in the future and also working with Lazeo to bring more new treatments to patients in the EU and to enhance the experience of aesthetic surgery.  Through intensive collaboration with Lazeo and other strategic partners,aims to expand its presence and bring more effective aesthetic medicine to the European market.