ABSTRACT
Background 1,4-butanediol diglycidyl ether (BDDE) is the most common cross-linker used to produce hyaluronic acid (HA)-based dermal fillers. However, BDDE may have cytotoxic and potentially mutagenic effects, raising safety concerns. Consequently, manufacturers are developing new HA filler formulations with reduced BDDE levels to mitigate potential biological risks. Here, we sought to evaluate the clinical outcomes of lip augmentation performed using an HA-based filler with a reduced BDDE content (Agex Fill Volume®; Biodue SpA, Barberino Tavarnelle, Italy) in a real-world clinical setting. Methods This was a prospective, open-label, multicenter, post-marketing study conducted over six months. Thirty adult subjects (29 women and one man) who desired a ≥1-point improvement on the validated Lip Fullness Scale 2 (LFS2) were enrolled. The primary efficacy endpoint was the post-procedural increase in the investigator-reported LFS2 compared to baseline. Other endpoints included self-perceived happiness assessed using the Happiness Measure Scale (HMS) and safety. Results Of the study participants, 73% (22/30) demonstrated an improvement of at least one point in their LFS2 scores immediately after treatment compared to baseline, thus qualifying as responders. Six months later, the responder rate, based on LFS2 scores, remained steady at 66.7% (20/30). Importantly, these aesthetic improvements were consistently associated with a positive impact on subject-reported HMS, with a significant difference (p < 0.001) between post-treatment and baseline scores. All adverse events (AEs) reported after treatment were mild. Conclusions Agex Fill Volume®, a HA filler with low BDDE content, provides a safe and effective option for enhancing lip volume in real-world aesthetic settings.
ABSTRACT
Radiesse® is a dermal filler made of calcium hydroxylapatite, a natural component of the human body, which, in diluted and hyperdiluted forms, promotes, unlike other fillers, neocollagenesis, neoelastinogenesis, fibroblast proliferation, and angiogenesis, leading to a long-term improved skin quality, elasticity, tightening, and firmness. This case series examined the use of Radiesse® (Merz, Frankfurt, Germany) for skin rejuvenation and regeneration through a long-lasting action of collagen biostimulation. The report explored for the first time the use of different dilution ratios of Radiesse® in 50 patients of varying ages and skin needs. By combining microboluses, tunneling, and/or fanning techniques, Radiesse® was superficially injected in different body regions, including the full-face, neck, décolletage, and hands. The treatment was effective in improving skin thickness, laxity, and wrinkles in 95% of 30-40 year-olds, 80% of 40-60 year-olds, and 70% of >60 year-olds, with an average improvement of 81.6% for the general population. The treatment was well-tolerated with no significant adverse effects reported. The report also describes specific cases and includes pictures comparing the baseline condition to the changes obtained after different months and Radiesse® sessions. The patients reported a clear improvement in skin firmness and brightness, as well as a visible improvement in wrinkles' appearance. This report found that diluting and hyperdiluting Radiesse® with flexible dilution ratios favoured a treatment's individualization, providing improved skin quality, elasticity, tightening, and firmness, without volume augmentation. In conclusion, it highlights the versatility and flexibility of Radiesse® and emphasizes its efficacy and safety in skin rejuvenation and regeneration.
