Mosaic for Midface Volume Loss

(PRIME Trial)

This trial explores whether the Mosaic Injectable Dermal Implant can safely and effectively restore volume in the midface area, which often thins due to aging. Researchers aim to determine the side effects experienced over 12 months and assess the treatment's effectiveness after six months. Participants will receive injections in their midface and may undergo a follow-up treatment if necessary. Ideal candidates are adults with noticeable volume loss in both cheeks. Participants will attend clinic visits for photos and maintain diaries to monitor any symptoms after treatment.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for midface volume loss.

Research has shown that the Mosaic Injectable Dermal Implant is generally safe for people. Earlier studies found no serious side effects when using similar fillers to restore midface volume. Some individuals experienced mild discomfort during the injection, but this was temporary and not severe.

A review of different fillers revealed a few rare cases of changes in facial bone structure at the injection sites. However, the FDA has approved many dermal fillers for restoring facial volume, indicating their general safety.

Unlike existing treatments for midface volume loss, which often involve hyaluronic acid fillers, the Mosaic Injectable Dermal Implant is unique because it offers a novel formulation designed for longer-lasting results. Researchers are excited about this treatment because it allows for precise volume restoration with up to 12 mL of the implant spread over two sessions, potentially reducing the frequency of treatments needed. This could mean fewer visits to the clinic and more sustained improvements in facial volume, making it a promising alternative for those seeking more durable solutions.

Studies have shown that injectable fillers, such as the Mosaic Injectable Dermal Implant being tested in this trial, can effectively restore volume in the midface. Research indicates that patients experienced an average increase of about 4.46 mL in facial volume within 45 days. Another study reported noticeable improvements in facial appearance and patient satisfaction over several months. Specifically, improvements in facial volume and appearance were observed at 6 and 9 months after treatment. Overall, these findings suggest that Mosaic could effectively treat age-related volume loss in the midface.³⁵⁶⁷⁸