A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area.
dermal filler
facial aging
hyaluronic acid
lips volume
perioral rejuvenation
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
Feb 2023
Historique:
revised:
16
05
2022
received:
18
04
2022
accepted:
30
05
2022
pubmed:
21
6
2022
medline:
14
2
2023
entrez:
20
6
2022
Statut:
ppublish
Résumé
Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers. To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines. This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS). In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up. The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.
Sections du résumé
BACKGROUND
BACKGROUND
Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers.
AIMS
OBJECTIVE
To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines.
MATERIALS AND METHODS
METHODS
This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS).
RESULTS
RESULTS
In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up.
CONCLUSIONS
CONCLUSIONS
The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection.
Identifiants
pubmed: 35718985
doi: 10.1111/jocd.15169
pmc: PMC10087550
doi:
Substances chimiques
Hyaluronic Acid
9004-61-9
Dermal Fillers
0
Types de publication
Multicenter Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
464-472Subventions
Organisme : Laboratoires FILLMED Paris, France
Informations de copyright
© 2022 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.
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