Dataset Information

Efficacy and safety of a new resilient hyaluronic acid dermal filler, in the correction of moderate-to-severe nasolabial folds: A 64-week, prospective, multicenter, controlled, randomized, double-blind and within-subject study.

ABSTRACT: BACKGROUND:Injectables that behave similarly to native tissue and preserve facial expressiveness represent a new frontier in aesthetic medicine. A range of fillers made of high molecular weight hyaluronic acid (HA) chains with low crosslinking have been specifically developed to complement facial dynamics. AIMS:The efficacy and safety of one of these resilient HA fillers, and its noninferiority to an effective comparator available in the US, were tested in the treatment of dynamic wrinkles. METHODS:A 15-month, prospective, multicenter, controlled, randomized, double-blind, within-subject (split-face) clinical trial was conducted on 140 subjects with moderate-to-severe nasolabial folds (NLF). Study endpoints included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators (BLE), subjects, and treating investigators (TI). Subject perception was evaluated with FACE-Q and satisfaction scales. RESULTS:The per-protocol population included 88 subjects (92% women) of all Fitzpatrick phototypes, with a mean age of 57 years. WSRS improvement was significantly greater with the resilient HA than its comparator over 15 months, including at week 24 (primary endpoint), as rated by BLE and TI. Results demonstrated the noninferiority of the resilient HA filler to its comparator. Aesthetic improvement and subject satisfaction were durably high, with an overall trend toward higher scores for the resilient HA filler. Both treatments were safe and well tolerated. CONCLUSION:The resilient HA filler made of long chains lightly crosslinked is at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin phototypes.

SUBMITTER: Kaufman-Janette J

PROVIDER: S-EPMC7384057 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy and safety of a new resilient hyaluronic acid dermal filler, in the correction of moderate-to-severe nasolabial folds: A 64-week, prospective, multicenter, controlled, randomized, double-blind and within-subject study.

Kaufman-Janette Joely J Taylor Susan C SC Cox Sue Ellen SE Weinkle Susan H SH Smith Stacy S Kinney Brian M BM

Journal of cosmetic dermatology 20190824 5

<h4>Background</h4>Injectables that behave similarly to native tissue and preserve facial expressiveness represent a new frontier in aesthetic medicine. A range of fillers made of high molecular weight hyaluronic acid (HA) chains with low crosslinking have been specifically developed to complement facial dynamics.<h4>Aims</h4>The efficacy and safety of one of these resilient HA fillers, and its noninferiority to an effective comparator available in the US, were tested in the treatment of dynamic ...[more]

PMID: 31444861

Similar Datasets

Project description:Introduction: The lips and the mouth play an indispensable role in vocalization, mastication and face aesthetics. Various noxious factors may alter and destruct the original structure, and appearance of the lips and the anatomical area surrounding the mouth. The application of hyaluronic acid (HA) may serve as a safe method for lip regeneration. Although a number of studies exist for HA effectiveness and safety, its beneficial effect is not well-established. Aim: The present meta-analysis and systematic review was performed to investigate the effectiveness of HA on lip augmentation. We also investigated the types and nature of adverse effects (AEs) of HA application. Methods: We reported our meta-analysis in accordance with the PRISMA Statement. PROSPERO protocol registration: CRD42018102899. We performed the systematic literature search in CENTRAL, Embase, and MEDLINE. Randomized controlled trials, cohort studies, case series and case reports were included. The untransformed proportion (random-effects, DerSimonian-Laird method) of responder rate to HA injection was calculated. For treatment related AEs descriptive statistics were used. Results: The systematic literature search yielded 32 eligible records for descriptive statistics and 10 records for quantitative synthesis. The results indicated that the overall estimate of responders (percentage of subjects with increased lip fullness by one point or higher) was 91% (ES = 0.91, 95% CI:0.85-0.96) 2 months after injection. The rate of responders was 74% (ES = 0.74, 95% CI:0.66-0.82) and 46% (ES = 0.46, 95% CI:0.28-0.65) after 6 and 12 months, respectively. We included 1,496 participants for estimating the event rates of AEs. The most frequent treatment-related AEs were tenderness (88.8%), injection site swelling (74.3%) and bruising (39.5%). Rare AEs included foreign body granulomas (0.6%), herpes labialis (0.6%) and angioedema (0.3%). Conclusion: Our meta-analysis revealed that lip augmentation with injectable HA is an efficient method for increasing lip fullness for at least up to 6 months after augmentation. Moreover, we found that most AEs of HA treatment were mild or moderate, but a small number of serious adverse effects were also found. In conclusion, further well-designed RCTs are still needed to make the presently available evidence stronger.

Dataset Information

Efficacy and safety of a new resilient hyaluronic acid dermal filler, in the correction of moderate-to-severe nasolabial folds: A 64-week, prospective, multicenter, controlled, randomized, double-blind and within-subject study.

Publications

Efficacy and safety of a new resilient hyaluronic acid dermal filler, in the correction of moderate-to-severe nasolabial folds: A 64-week, prospective, multicenter, controlled, randomized, double-blind and within-subject study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets