Long-Term Efficacy and Tolerability of a Medium G' HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone

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 topographic...

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Bibliographic Details
Published in:Clinical, cosmetic and investigational dermatology cosmetic and investigational dermatology, 2023-07, Vol.16, p.1795-1805
Main Authors: David, Michel, Braccini, Frederic, Garcia, Philippe, Loreto, Frederic, Benadiba, Laurent, Gorj, Mihai, Grand-Vincent, Anne, Rumyantseva Mathey, Elena, Deutsch, Jean-Jacques, Ehlinger, Agnès, Cartier, Hugues, Nadra, Karim, Fanian, Ferial
Format: Article
Language:English
Subjects:
anti-ageing
Care and treatment
Clinical Trial Report
dermal fillers
facial injections
Hyaluronic acid
Medical equipment
peri-oral area
Physiological apparatus
Skin
skin rejuvenation
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Summary: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. 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. 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. AFU was well tolerated and showed a continuous efficacy for at least 18 months, in exploratory analyses.
ISSN:1178-7015
1178-7015
DOI:10.2147/CCID.S395353