Ellansé S for Nasolabial Folds

This trial aims to evaluate the safety and effectiveness of a new dermal filler, ELLANSÉ®-S, for treating nasolabial folds (the lines running from the sides of the nose to the corners of the mouth). Participants will receive ELLANSÉ®-S on one side of the face and a standard filler, Radiesse®, on the other, enabling researchers to compare results. The trial seeks individuals with noticeable nasolabial folds who have not recently undergone facial aesthetic procedures and are willing to avoid them during the study. As an unphased trial, this study offers participants the chance to contribute to the scientific understanding of new aesthetic treatments.

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like high-dose Vitamin E, aspirin, anti-inflammatories, and others that could increase bleeding risk should not be taken within two weeks before or one week after treatment. It's best to discuss your specific medications with the trial team.

Previous studies have shown that Ellansé S is well-tolerated for treating nasolabial folds (NLFs), the lines from the sides of the nose to the corners of the mouth. Research indicates that the treatment is generally safe, with common side effects including minor issues like bruising, swelling, tenderness, or small lumps at the injection site. These effects are typical with dermal fillers and usually resolve on their own.

Polycaprolactone, a key ingredient in Ellansé S, has been tested and found effective and safe in other studies, including those with Chinese patients who had moderate-to-severe NLFs, providing reassurance about its safety.

The control treatment, Radiesse, a well-known filler made from calcium hydroxylapatite, is also generally well-tolerated. Like Ellansé S, it may cause minor side effects such as swelling or tenderness.

Unlike other treatments for nasolabial folds, ELLANSÉ®-S is unique because it combines polycaprolactone with carboxymethylcellulose gel. This combination is designed to provide both immediate volume and stimulate collagen production over time, potentially offering longer-lasting results than standard options like hyaluronic acid fillers. Researchers are excited about ELLANSÉ®-S as it not only fills wrinkles but also encourages the skin to rejuvenate itself, potentially leading to more natural and durable improvements.

Research has shown that Ellansé S, a type of dermal filler, effectively treats smile lines around the mouth, known as nasolabial folds (NLFs). In this trial, participants will receive either Ellansé S or Calcium Hydroxylapatite, another dermal filler. Previous studies demonstrated that when one side of the face was treated with Ellansé S, patients had fewer wrinkles at 6, 9, and 12 months compared to other treatments. By 24 months, all participants showed improvement in their wrinkles based on a standard improvement scale. Overall, Ellansé S proved more effective in reducing wrinkles and increasing patient satisfaction. These results suggest that Ellansé S is a promising choice for improving the appearance of NLFs.¹²⁶⁷⁸