Journal of Clinical Trials
Open Access

Abstract

Efficacy and Tolerance of an Injectable Medical Device Containing Hyaluronic Acid and Amino acids: A Monocentric Six-Month Open-Label Evaluation

Sparavigna A and Orlandini A

Background: An innovative injectable solution containing low molecular hyaluronic acid (HA) and a specific Amino Acids mixture was formulated to physiologically promote local neo-collagenesis and elastogenesis through fibroblasts chemotaxis migration into the injected area.
Objective: Aim of this open clinical trial is to evaluate efficacy and tolerance of the injectable product under study, on main sign of face skin photoaging.
Methods: A single Italian center treated 25 female subjects aged 48-65 years with 4 micro-injection sessions with 10-day time laps between each product administration. Subjects were evaluated in basal conditions and after 4, 8, 12 and 24 weeks, using validated clinical scales, subjective evaluations and objective quantitative outcome measures. Assessment of aesthetic results included photographic documentation.
Results: Obtained results showed an improvement of all the clinical and subjective assessments and on the majority of objective instrumental parameters. These were already significant 10 days after the first injection procedure and were still significant and still improving after 6 months (at follow up). Global judgment on tolerability was good/excellent, both in the investigators’ opinion and volunteers’ self-evaluation.
Conclusions: Obtained results confirm the aesthetic performance of the injectable product on main signs of face skin photoaging. In particular, it was demonstrated the biovolumetric effect, the antiwrinkle efficacy, a superficial and deep moisturising activity and elasticizing properties. This study supports the definition of extracellular matrix targeting (ECM-targeting) for this product.