Efficacy and tolerance of an injectable medical device containing stable hybrid cooperative complexes of high- and low-molecular-weight hyaluronic acid: a monocentric 16 weeks open-label evaluation

Abstract

BackgroundAn injectable medical device containing stable hybrid cooperative complexes of high- and low-molecular-weight hyaluronic acid (HA) has been developed with characteristics suited for a global improvement of facial esthetics.ObjectiveTo evaluate the HA product performance in improving some key facial esthetic features. The study employed clinical scales, subjective evaluations, and facial skin objective measurements.MethodsA single Italian site treated 64 female subjects aged 38–60 years, with injections at five predetermined points, on each side of the face, with a 4-week time lapse between the first and the second product administration. Subjects were evaluated after 4, 8, 12, and 16 weeks, using validated clinical scales, subjective evaluation, and objective quantitative outcome measures. Assessment of esthetic results included photographic documentation.ResultsBoth the clinical and subjective assessments, and the majority of objective instrumental parameters indicated an improvement throughout the study and were already significant at week 4 or 8 and were still significant at week 16 (3 months after the second treatment). Minor and temporary local skin reactions were observed in 23% of subjects at the site of the injections, and the global judgment on tolerability was good or excellent, both in the investigators’ opinion and volunteers’ self-evaluation.ConclusionBoth subjective and objective improvement of the facial parameters was consistent with the bio-remodeling purpose, and persistent and still statistically significant at the end of the study. The tolerability and safety profile of the product were judged good or excellent both by investigators and volunteers. This study supports the claim for bio-remodeling of these stable hybrid cooperative complexes of low- and high-molecular-weight HA.

Hybrid Complexes of High and Low Molecular Weight Hyaluronans Highly Enhance HASCs Differentiation: Implication for Facial Bioremodelling

“…They were used in comparative in vitro studies and using different cellular models [24,35]. They have recently been commercially available for aesthetic medicine use, and with reports have shown that HCCs were particularly suitable for the treatment of skin laxity of malar and submalar areas, and for counteracting facial aging [36,37]. Such clinical outcomes were also beneficial for the improvement of skin elasticity in areas such as temples, forehead, hands, inner arms and neck.…”

Filling the periorbital hollows with hyaluronic acid gel: Long‐term review of outcomes and complications

“…Several patients in this study were noted to have retained effect of filler more than 5 years postinjection, with one case even noted at the 10‐year follow‐up, while others had lost effect at the 6‐month visit. Many different combinations of HAG filler exist, and the effect profile may be related to the degree of cross‐linkage as well as the molecular weight of the HAG filler used . More recent formulations include mixtures of low‐ and high‐molecular weight HAG, as well as cross‐linked and autocross linked combinations which promise a longer duration of effect .…”

“…Many different combinations of HAG filler exist, and the effect profile may be related to the degree of cross‐linkage as well as the molecular weight of the HAG filler used . More recent formulations include mixtures of low‐ and high‐molecular weight HAG, as well as cross‐linked and autocross linked combinations which promise a longer duration of effect . Long‐term data on the duration and side effect profile of these combination fillers are yet to be determined …”

“…More recent formulations include mixtures of low‐ and high‐molecular weight HAG, as well as cross‐linked and autocross linked combinations which promise a longer duration of effect . Long‐term data on the duration and side effect profile of these combination fillers are yet to be determined …”

“…13,14 More recent formulations include mixtures of low-and high-molecular weight HAG, as well as cross-linked and autocross linked combinations which promise a longer duration of effect. 13,14 Long-term data on the duration and side effect profile of these combination fillers are yet to be determined. 13,14 Over the 10 years of the study, our overall approach became more conservative so that smaller volumes of filler were injected in general.…”