Comparative clinical study for the efficacy and safety of two different hyaluronic acid-based fillers with Tri-Hyal versus Vycross technology: A long-term prospective randomized clinical trial.


Journal

Journal of cosmetic dermatology
ISSN: 1473-2165
Titre abrégé: J Cosmet Dermatol
Pays: England
ID NLM: 101130964

Informations de publication

Date de publication:
Feb 2023
Historique:
revised: 07 06 2022
received: 28 03 2022
accepted: 23 06 2022
pubmed: 1 7 2022
medline: 14 2 2023
entrez: 30 6 2022
Statut: ppublish

Résumé

Hyaluronic acid-based fillers have an immediate volumizing effect for the treatment of dermal contour deformities and to smooth dermal depressions formed by the loss of volume. A previous study on 2016-2018 has shown the efficacy and safety of the HA-based filler ART FILLER® Volume on the midface only, but not in a comparative manner. In this context, an 18 months prospective randomized single-blind study of the non-inferiority of ART FILLER® Volume versus the reference product Juvéderm Voluma® was performed on the midface, temple, and jawline, and non-comparative study on the chin. The efficacy and the longevity were evaluated for the selected face areas via dedicated clinical scoring systems after a single filler injection without any re-touch or re-injection. The short- and long-term adverse effects were also recorded. The observations confirmed the non-inferiority of ART FILLER® Volume versus the reference product on the different injected areas. For both fillers, the beneficial effects on volumes restoration were maintained 18 months post-injection; however, these effects were diminished among the time. Furthermore, injections of Art Filler® Volume were well tolerated by the subjects and showed less acute side effects compared with the reference product that may be explained by a lower induction of inflammation.

Sections du résumé

BACKGROUND BACKGROUND
Hyaluronic acid-based fillers have an immediate volumizing effect for the treatment of dermal contour deformities and to smooth dermal depressions formed by the loss of volume. A previous study on 2016-2018 has shown the efficacy and safety of the HA-based filler ART FILLER® Volume on the midface only, but not in a comparative manner.
METHODS METHODS
In this context, an 18 months prospective randomized single-blind study of the non-inferiority of ART FILLER® Volume versus the reference product Juvéderm Voluma® was performed on the midface, temple, and jawline, and non-comparative study on the chin. The efficacy and the longevity were evaluated for the selected face areas via dedicated clinical scoring systems after a single filler injection without any re-touch or re-injection. The short- and long-term adverse effects were also recorded.
RESULTS RESULTS
The observations confirmed the non-inferiority of ART FILLER® Volume versus the reference product on the different injected areas. For both fillers, the beneficial effects on volumes restoration were maintained 18 months post-injection; however, these effects were diminished among the time. Furthermore, injections of Art Filler® Volume were well tolerated by the subjects and showed less acute side effects compared with the reference product that may be explained by a lower induction of inflammation.

Identifiants

pubmed: 35770300
doi: 10.1111/jocd.15200
pmc: PMC10084174
doi:

Substances chimiques

Hyaluronic Acid 9004-61-9
Dermal Fillers 0

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

473-485

Informations de copyright

© 2022 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.

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Auteurs

Frederic Braccini (F)

Private clinic, Nice, France.

Ferial Fanian (F)

Laboratoires FILL-MED, Paris, France.

Philippe Garcia (P)

Private Clinic, Paris, France.

Henry Delmar (H)

Mediti Clinic, Antibes, France.

Federico Loreto (F)

Private Clinic, Paris, France.

Laurent Benadiba (L)

Private Clinic, Paris, France.

Karim Nadra (K)

Laboratoires FILL-MED, Paris, France.

Philippe Kestemont (P)

Mediti Clinic, Antibes, France.

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Classifications MeSH