Long-Term Efficacy and Tolerability of a Medium G’ HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone
Michel David,1 Frederic Braccini,2 Philippe Garcia,3 Frederic Loreto,3 Laurent Benadiba,3 Mihai Gorj,3 Anne Grand-Vincent,3 Elena Rumyantseva Mathey,3 Jean-Jacques Deutsch,3 Agnès Ehlinger,4 Hugues Cartier,5 Karim Nadra,6 Ferial Fanian6 1Private Clinic, Metz, France; 2Private Clinic, Nice, France; 3...
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Format: | Article |
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Dove Medical Press
2023-07-01
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Series: | Clinical, Cosmetic and Investigational Dermatology |
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Online Access: | https://www.dovepress.com/long-term-efficacy-and-tolerability-of-a-medium-g-ha-filler-with-tri-h-peer-reviewed-fulltext-article-CCID |
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author | David M Braccini F Garcia P Loreto F Benadiba L Gorj M Grand-Vincent A Rumyantseva Mathey E Deutsch JJ Ehlinger A Cartier H Nadra K Fanian F |
author_facet | David M Braccini F Garcia P Loreto F Benadiba L Gorj M Grand-Vincent A Rumyantseva Mathey E Deutsch JJ Ehlinger A Cartier H Nadra K Fanian F |
author_sort | David M |
collection | DOAJ |
description | Michel David,1 Frederic Braccini,2 Philippe Garcia,3 Frederic Loreto,3 Laurent Benadiba,3 Mihai Gorj,3 Anne Grand-Vincent,3 Elena Rumyantseva Mathey,3 Jean-Jacques Deutsch,3 Agnès Ehlinger,4 Hugues Cartier,5 Karim Nadra,6 Ferial Fanian6 1Private Clinic, Metz, France; 2Private Clinic, Nice, France; 3Private Clinic, Paris, France; 4Private Clinic, Thionville, France; 5Private Clinic, Arras, France; 6Laboratories Fill-Med, Paris, FranceCorrespondence: Ferial Fanian, Tel +33673761820, Email fanian@gmail.comPurpose: 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.Keywords: hyaluronic acid, dermal fillers, facial injections, anti-aging, skin rejuvenation, perioral area |
first_indexed | 2024-03-12T23:18:29Z |
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id | doaj.art-9cc2dad5926a4fb2a4b626e9fd740ad3 |
institution | Directory Open Access Journal |
issn | 1178-7015 |
language | English |
last_indexed | 2024-03-12T23:18:29Z |
publishDate | 2023-07-01 |
publisher | Dove Medical Press |
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series | Clinical, Cosmetic and Investigational Dermatology |
spelling | doaj.art-9cc2dad5926a4fb2a4b626e9fd740ad32023-07-16T16:02:53ZengDove Medical PressClinical, Cosmetic and Investigational Dermatology1178-70152023-07-01Volume 161795180585129Long-Term Efficacy and Tolerability of a Medium G’ HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial ZoneDavid MBraccini FGarcia PLoreto FBenadiba LGorj MGrand-Vincent ARumyantseva Mathey EDeutsch JJEhlinger ACartier HNadra KFanian FMichel David,1 Frederic Braccini,2 Philippe Garcia,3 Frederic Loreto,3 Laurent Benadiba,3 Mihai Gorj,3 Anne Grand-Vincent,3 Elena Rumyantseva Mathey,3 Jean-Jacques Deutsch,3 Agnès Ehlinger,4 Hugues Cartier,5 Karim Nadra,6 Ferial Fanian6 1Private Clinic, Metz, France; 2Private Clinic, Nice, France; 3Private Clinic, Paris, France; 4Private Clinic, Thionville, France; 5Private Clinic, Arras, France; 6Laboratories Fill-Med, Paris, FranceCorrespondence: Ferial Fanian, Tel +33673761820, Email fanian@gmail.comPurpose: 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.Keywords: hyaluronic acid, dermal fillers, facial injections, anti-aging, skin rejuvenation, perioral areahttps://www.dovepress.com/long-term-efficacy-and-tolerability-of-a-medium-g-ha-filler-with-tri-h-peer-reviewed-fulltext-article-CCIDhyaluronic aciddermal fillersfacial injectionsanti-ageingskin rejuvenationperi-oral area |
spellingShingle | David M Braccini F Garcia P Loreto F Benadiba L Gorj M Grand-Vincent A Rumyantseva Mathey E Deutsch JJ Ehlinger A Cartier H Nadra K Fanian F Long-Term Efficacy and Tolerability of a Medium G’ HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone Clinical, Cosmetic and Investigational Dermatology hyaluronic acid dermal fillers facial injections anti-ageing skin rejuvenation peri-oral area |
title | Long-Term Efficacy and Tolerability of a Medium G’ HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone |
title_full | Long-Term Efficacy and Tolerability of a Medium G’ HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone |
title_fullStr | Long-Term Efficacy and Tolerability of a Medium G’ HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone |
title_full_unstemmed | Long-Term Efficacy and Tolerability of a Medium G’ HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone |
title_short | Long-Term Efficacy and Tolerability of a Medium G’ HA Filler with Tri-Hyal Technology on the Rejuvenation of the Mobile Facial Zone |
title_sort | long term efficacy and tolerability of a medium g rsquo ha filler with tri hyal technology on the rejuvenation of the mobile facial zone |
topic | hyaluronic acid dermal fillers facial injections anti-ageing skin rejuvenation peri-oral area |
url | https://www.dovepress.com/long-term-efficacy-and-tolerability-of-a-medium-g-ha-filler-with-tri-h-peer-reviewed-fulltext-article-CCID |
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