A prospective, open-label, multicentric, single-arm, post-marketing clinical study to evaluate effectiveness and safety of Cross-Linked Sodium Hyaluronate 24mg with Lidocaine 3mg Injection in subjects undergoing treatment for facial wrinkles and lip augmentation.
Cross-Linked Sodium Hyaluronate
aging treatment
facial wrinkles
lip augmentation
Journal
Journal of cosmetic dermatology
ISSN: 1473-2165
Titre abrégé: J Cosmet Dermatol
Pays: England
ID NLM: 101130964
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
received:
03
05
2021
accepted:
06
05
2021
pubmed:
23
5
2021
medline:
7
8
2021
entrez:
22
5
2021
Statut:
ppublish
Résumé
Hyaluronic acid (HA) fillers are quite commonly used since several years for soft tissue augmentation. The purpose of this study was to evaluate primarily the safety and secondarily the clinical effectiveness of Cross-Linked Sodium Hyaluronate 24 mg with Lidocaine 3 mg (Jeunesso 24L) injection, in subjects undergoing treatment for facial wrinkles and lip augmentation. Patients between the age groups of 18 and 75 years, who were seeking soft tissue augmentation treatment on the face and with wrinkle severity score (WSS) ≥2 for bilateral Nasolabial Folds (NLF), were included in the study. The appropriate quantity of the filler was injected at the treatment site. Clinical efficacy assessments were conducted independently at 3 and 6 months after baseline. Clinical efficacy was assessed using Wrinkle Severity Rating Scale (WSRS) and a Global Aesthetic Improvement Scale (GAIS). The mean pain score was found to be 2.57 ± 2.06 immediately after injection which was reduced to 0.1 ± 0.675 at 15 min and this further subsided to "No Pain" in any of the participants at 60 min post the injection. WSRS mean score before treatment was 2.76, which were significantly reduced to 2.14, at 3 months. Majority of participants found an improvement in the marionette line severity. Also, significant improvements were seen in the perioral and lip areas. The Study filler was well-tolerated and no side effects were reported. The study indicates that this particular filler, HA+L, is useful for cosmetic improvements in the nasolabial folds and for enhancement of the lips.
Sections du résumé
BACKGROUND
BACKGROUND
Hyaluronic acid (HA) fillers are quite commonly used since several years for soft tissue augmentation.
AIM
OBJECTIVE
The purpose of this study was to evaluate primarily the safety and secondarily the clinical effectiveness of Cross-Linked Sodium Hyaluronate 24 mg with Lidocaine 3 mg (Jeunesso 24L) injection, in subjects undergoing treatment for facial wrinkles and lip augmentation.
METHOD
METHODS
Patients between the age groups of 18 and 75 years, who were seeking soft tissue augmentation treatment on the face and with wrinkle severity score (WSS) ≥2 for bilateral Nasolabial Folds (NLF), were included in the study. The appropriate quantity of the filler was injected at the treatment site. Clinical efficacy assessments were conducted independently at 3 and 6 months after baseline. Clinical efficacy was assessed using Wrinkle Severity Rating Scale (WSRS) and a Global Aesthetic Improvement Scale (GAIS).
RESULTS
RESULTS
The mean pain score was found to be 2.57 ± 2.06 immediately after injection which was reduced to 0.1 ± 0.675 at 15 min and this further subsided to "No Pain" in any of the participants at 60 min post the injection. WSRS mean score before treatment was 2.76, which were significantly reduced to 2.14, at 3 months. Majority of participants found an improvement in the marionette line severity. Also, significant improvements were seen in the perioral and lip areas. The Study filler was well-tolerated and no side effects were reported.
CONCLUSION
CONCLUSIONS
The study indicates that this particular filler, HA+L, is useful for cosmetic improvements in the nasolabial folds and for enhancement of the lips.
Substances chimiques
Dermal Fillers
0
Hyaluronic Acid
9004-61-9
Lidocaine
98PI200987
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2472-2479Subventions
Organisme : BIOTECH VISION CARE PVT. LTD
Informations de copyright
© 2021 Wiley Periodicals LLC.
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