Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects.
Princess®
Princess® VOLUME
effectiveness
nasolabial folds
safety
treatment satisfaction
Journal
Clinical, cosmetic and investigational dermatology
ISSN: 1178-7015
Titre abrégé: Clin Cosmet Investig Dermatol
Pays: New Zealand
ID NLM: 101543449
Informations de publication
Date de publication:
2019
2019
Historique:
entrez:
23
1
2019
pubmed:
23
1
2019
medline:
23
1
2019
Statut:
epublish
Résumé
Modified sodium hyaluronate gel for injection, Princess To evaluate the safety and effectiveness of PV in correction of moderate-to-severe nasolabial folds (NLF) in Chinese subjects. In this prospective, split-face, randomized, evaluator and subject-blinded, multicenter, noninferiority trial, 120 subjects were randomized to bilateral NLF treatment with PV administered in one NLF and Restylane Among the 115 subjects who completed the study, median initial and touch-up volumes (mL) were 1.00 for both groups with a maximum dosage per NLF of 2.00 and a minimum of 0.30 for PV and 0.60 for RL. At week 24, the Wrinkle Severity Rating Scale improvement rate, as assessed by the IRC, reached 68.70% for PV and 52.17% for RL. The results indicate that PV is noninferior to RL ( This study confirms that PV is a safe and effective treatment for the correction of moderate-to-severe NLFs in Chinese subjects.
Sections du résumé
BACKGROUND
BACKGROUND
Modified sodium hyaluronate gel for injection, Princess
OBJECTIVE
OBJECTIVE
To evaluate the safety and effectiveness of PV in correction of moderate-to-severe nasolabial folds (NLF) in Chinese subjects.
METHODS
METHODS
In this prospective, split-face, randomized, evaluator and subject-blinded, multicenter, noninferiority trial, 120 subjects were randomized to bilateral NLF treatment with PV administered in one NLF and Restylane
RESULTS
RESULTS
Among the 115 subjects who completed the study, median initial and touch-up volumes (mL) were 1.00 for both groups with a maximum dosage per NLF of 2.00 and a minimum of 0.30 for PV and 0.60 for RL. At week 24, the Wrinkle Severity Rating Scale improvement rate, as assessed by the IRC, reached 68.70% for PV and 52.17% for RL. The results indicate that PV is noninferior to RL (
CONCLUSION
CONCLUSIONS
This study confirms that PV is a safe and effective treatment for the correction of moderate-to-severe NLFs in Chinese subjects.
Identifiants
pubmed: 30666143
doi: 10.2147/CCID.S187079
pii: ccid-12-057
pmc: PMC6336025
doi:
Types de publication
Journal Article
Langues
eng
Pagination
57-62Déclaration de conflit d'intérêts
Disclosure XD and LL have been principal investigators in the clinical study. SH, ZIS, ABZ and MP are employees of CROMA-PHARMA. WP and RRB are past employees of CROMA-PHARMA. The authors report no other conflicts of interest in this work.
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