BackgroundCosmetic procedures are growing ever more common, and the use of soft tissue fillers is increasing. Practicing physicians need to be aware of the biological behavior of these products in tissue to enable them to respond to any safety concerns that their patients raise.ObjectivesTo provide an overview of the metabolism of 1,4-butanediol diglycidyl ether (BDDE)-crosslinked hyaluronic acid (HA) dermal fillers and to examine the safety of the resulting byproducts.MethodsA review of available evidence was conducted.ResultsAfter reaction with HA, the epoxide groups of BDDE are neutralized, and only trace amounts of unreacted BDDE remain in the product (<2 parts per million). When crosslinked HA, uncrosslinked HA, and unreacted BDDE degrade, they break down into harmless byproducts or into byproducts that are identical to substances already found in the skin.ConclusionClinical and biocompatibility data from longer than 15 years support the favorable clinical safety profile of BDDE-crosslinked HA and its degradation products. Given the strength of the empirical evidence, physicians should be confident in offering these products to their patients.
Objective To determine the optimum duration for the 25 min. The patients' discomfort was recorded using a 4-point descriptive pain scale and a 100 mm nonretention of 2% lignocaine gel intraurethrally as an anaesthetic for flexible cystoscopy in men.graphical visual analogue scale. Results In the first study, those patients receiving lignoPatients and methods A prospective, randomized, double-blind, placebo-controlled trial was conducted caine gel for 25 min experienced significantly less pain than the other three groups. In the second, lignocaine in two parts. Initially, the importance of duration was determined, i.e. whether pain relief was significantly gel in the urethra for 15 min provided the same level of pain relief as lignocaine for 25 min. improved when lignocaine gel was instilled for longer than is currently practised. As pain relief was improved Conclusion Pain during flexible cystoscopy can be significantly reduced when 20 mL of 2% lignocaine gel by retaining the lignocaine gel for longer, the optimum time was determined in a second trial. Initially, 90 is left in the urethra for 15 min; lignocaine gel would be more eÂective when left for longer than is currently patients were divided into four groups receiving 20 mL of 2% lignocaine gel or plain lubricating gel for 5 or practised. Keywords Local anaesthesia, flexible cystoscopy, topical 25 min. Subsequently, 60 men were divided into two groups receiving 20 ml of 2% lignocaine gel for 15 or lignocaine gel, urethra whether pain relief was significantly improved when
Hyaluronic acid (HA)-based injectable fillers three-dimensionally restore the natural contours of the lips and perioral area, thereby reducing some signs of aging lips. To evaluate the short-term aesthetic impact of treatment with the HA dermal filler Juvéderm® VOLBELLA® with Lidocaine, formulated utilizing VYCROSS™ technology, for enhancement or correction of asymmetry of the lips, evaluated using a patient-centric approach. Sixty-two subjects were enrolled in this study, conducted at two sites in Germany. Primary endpoints were satisfaction with improvement, look and feel of the lips, assessed by subject and physician at first visit and 4 weeks post-treatment. Immediately after injection at first visit, 83.6% of subjects were Extremely Satisfied, Very Satisfied or Satisfied with improvement in the lips, which increased to 94.1% and 93.0% of subjects with/without top-up treatment at follow-up, respectively. After injection at first visit, 61.7% of subjects rated the look and feel of their lips as Extremely Natural or Very Natural, which increased to 75.0% and 93.0% of subjects with/without top-up treatment, respectively. The HA dermal filler was associated with minimal discomfort, bruising or swelling of the lips; almost two-thirds of subjects (62%) returned to social engagements on the same day. The high degree of subject satisfaction with aesthetic improvement in the lips, as well as the natural look and feel, indicates that this HA dermal filler represents an effective treatment option for patients requiring lip enhancement.
BACKGROUNDVYC-17.5L (17.5 mg/mL hyaluronic acid, 0.3% lidocaine) is a dermal filler intended for deep dermis injection for the treatment of skin depressions.OBJECTIVETo evaluate 12-month effectiveness and safety of VYC-17.5L for the treatment of moderate/severe nasolabial folds (NLFs).METHODSSubjects ≥18 years old with moderate/severe NLFs were recruited (N = 70). Injected volume was aimed at achieving optimum correction; top-up treatment was given at 2 weeks if needed. The primary endpoint was investigator-assessed change in NLF severity over 12 months using the validated photonumeric NLF Severity Scale. Secondary endpoints included investigator- and subject-assessed satisfaction and safety. Adverse events judged to be more severe or prolonged than routinely observed were recorded.RESULTSSixty-five subjects completed study requirements. Mean volume injected was 3.0 ± 1.0 mL for both NLFs combined. Significant improvement was maintained in investigator-assessed NLF severity at 12 months, and investigators and subjects reported high satisfaction with VYC-17.5L throughout the study. Two unexpected adverse events were reported: (1) redness, swelling, and decreased sensitivity (resolved after 4 days) and (2) swelling (resolved after 48 hours); neither event was serious or life threatening.CONCLUSIONVYC-17.5L is effective and well tolerated for the treatment of moderate to severe NLFs for 1 year.
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