RESUMO
Purpose: Injectable hyaluronic acid-based fillers are commonly used for the correction of skin contour irregularities and to smooth skin depressions formed by volume loss during the aging process. These fillers are particularly efficient to restore perioral skin depressions/wrinkles or to correct topographical anomalies. The European directives require a continuous evaluation of the performance of these medical devices, particularly for CE marked products. Methods: An 18-month prospective randomized single-blind study for the efficacy and safety of ART FILLER Universal (AFU) was performed on the lips, the nasolabial folds, and the marionettes lines. The evaluations were performed on 153 subjects enrolled in this study. The efficacy, the longevity, and the safety were evaluated for the injected areas via area specific clinical scoring after a single injection with the filler and with no re-touch. Results: We showed here that filler injection induced potent improvements of volume restoration after a single injection on all the treated areas. These beneficial properties of the filler were significant 3 weeks after injection and during the whole study period. Moreover, injections of the filler were well tolerated by the subjects. The recorded adverse events are routinely seen with HA fillers for face volume corrections, and most of these local reactions resolved within 14 days. Conclusion: AFU was well tolerated and showed a continuous efficacy for at least 18 months, in exploratory analyses.
RESUMO
Background: Biorevitalization solutions contain numerous nutritive compounds to improve skin quality. Dermal fillers like HA (hyaluronic acid), depending on rheological characteristics, are used to fill large static defaults with a sustained long-term efficacy. Treatments with either dermal filler or biorevitalization solutions alone are not enough to bring a global facial aging approach. Objective: To demonstrate the anti-aging performance and safety of a new protocol, BIONUTRILIFT, which combined an HA-based filler with Tri-Hyal technology and a skin biorevitalizer, to target the skin quality and wrinkles correction at the same time. Materials and Methods: Eligible subjects were enrolled based on a score of 2, 3, 4, or 5 on Bazin cheek folds wrinkle scale. Safety outcomes measured were immediate and local tolerability. Performance outcomes measured included: proportion of subjects in whom the severity of cheeks folds, nasolabial folds, marionette lines, upper lip wrinkles and skin radiance remained at least one point below the baseline measurement (Bazin scale) Global Aesthetic Improvement Scale scores by subjects and investigators. Results: In performance analyses with the combined protocol, skin radiance and cheek folds wrinkle correction sustained during the four-month study and decrease by 61% and 55%, respectively. 96% and 77% of subjects respectively showed at least a one-point decrease in the mean skin radiance score and Bazin score compared with baseline. Interestingly, the BIONUTRILIFT protocol showed the distance effect of vector A (cheek injection) and vector B (mandibular injection) on perioral zone and remained significant even 120 days after injections. Adverse events (AEs) were consistent with the expected AEsthat occurred after dermal injections. No serious AEswere recorded. Conclusion: BIONUTRILIFT may satisfy the subjects' demand by obtaining in the same session a simple, personalized, noninvasive, atraumatic, and reproductible technique.
