Ultra Plus Research Articles

A multi‐center, double‐blind, randomized controlled study of the safety and effectiveness of Juvéderm® injectable gel with and without lidocaine

Pain is a common patient complaint during dermal filler injections. The primary objective of this study was to compare a new formulation of Juvéderm((R)) injectable gel with lidocaine (denoted as JUV + L) to commercially-available Juvéderm((R)) injectable gel without lidocaine (denoted as JUV) with respect to procedural pain scores in subjects desiring nasolabial fold (NLF) correction. Subjects received randomized treatment with the lidocaine filler in one NLF and the filler without lidocaine in the other NLF. Investigators determined the appropriate formulation (Ultra or Ultra Plus) and volume of material to inject but were blinded as to which syringe contained lidocaine. Subjects rated procedural pain (pain during injection) using an 11-point scale within 30 min after receiving treatment in both NLFs and compared procedural pain between right and left NLFs using a 5-point scale. NLF severity was rated by both subjects and investigators before and 2 weeks after treatment. The mean difference on the procedural pain scale was 3.4 (P < 0.0001), and 93% of subjects found JUV + L to be less or slightly less painful than JUV. Improvement in NLF severity was comparable for both products. Common treatment site reactions (CTRs) of pain and tenderness were considerably less frequent for JUV + L than JUV while all other CTRs showed no statistically significant differences. The dermal filler formulated with lidocaine is effective in reducing procedural pain during correction of facial wrinkles and folds while maintaining a similar safety and effectiveness profile to the filler without lidocaine.

Hyaluronic acid gel (Juvéderm) preparations in the treatment of facial wrinkles and folds.

Soft tissue augmentation with temporary dermal fillers is a continuously growing field, supported by the ongoing development and advances in technology and biocompatibility of the products marketed. The longer lasting, less immunogenic and thus more convenient hyaluronic acid (HA) fillers are encompassing by far the biggest share of the temporary dermal filler market. Since the approval of the first HA filler, Restylane, there are at least 10 HA fillers that have been approved by the FDA. Not all of the approved HA fillers are available on the market, and many more are coming. The Juvéderm product line (Allergan, Irvine, CA), consisting of Juvéderm Plus and Juvéderm Ultra Plus, was approved by the FDA in 2006. Juvéderm is a bacterium-derived nonanimal stabilized HA. Juvéderm Ultra and Ultra Plus are smooth, malleable gels with a homologous consistency that use a new technology called "Hylacross technology". They have a high concentration of cross-linked HAs, which accounts for its longevity. Juvéderm Ultra Plus is used for volumizing and correcting deeper folds, whereas Juvéderm Ultra is best for contouring and volumizing medium depth facial wrinkles and lip augmentation. Various studies have shown the superiority of the HA filler products compared with collagen fillers for duration, volume needed, and patient satisfaction. Restylane, Perlane, and Juvéderm are currently the most popular dermal fillers used in the United States.

Rapid, Opioid-sensitive Mechanisms Involved in Transient Receptor Potential Vanilloid 1 Sensitization

TRPV1 is a nociceptive, Ca2+-selective ion channel involved in the development of several painful conditions. Sensitization of TRPV1 responses by cAMP-dependent PKA crucially contributes to the development of inflammatory hyperalgesia. However, the pathways involved in potentiation of TRPV1 responses by cAMP-dependent PKA remain largely unknown. Using HEK cells stably expressing TRPV1 and the mu opioid receptor, we demonstrated that treatment with the adenylate cyclase activator forskolin significantly increased the multimeric TRPV1 species. Pretreatment with the mu opioid receptor agonist morphine reversed this increased TRPV1 multimerization. FRET analysis revealed that treatment with forskolin did not cause multimerization of pre-existing TRPV1 monomers on the plasma membrane and that intracellular pools of TRPV1 exist mostly as monomers in this model. This suggests that increased TRPV1 multimerization occurred from an intracellular store of inactive TRPV1 monomers. Treatment with forskolin also caused an increase in TRPV1 expression on the plasma membrane not resulting from increased TRPV1 expression, and this rapid TRPV1 translocation was inhibited by treatment with morphine. Thus, potentiation of TRPV1 responses by cAMP-dependent PKA involves plasma membrane insertion of functional TRPV1 multimers formed from an intracellular store of inactive TRPV1 monomers. This potentiation occurs rapidly and can be dynamically modulated by activation of the mu opioid receptor under conditions where cAMP levels are raised, such as with inflammation. Increased translocation and multimerization of TRPV1 channels provide a cellular mechanism for fine-tuning of nociceptive responses that allow for rapid modulation of TRPV1 responses independent of transcriptional changes.

Effectiveness of Juvéderm Ultra Plus Dermal Filler in the Treatment of Severe Nasolabial Folds

With the baby boomer generation firmly ensconced in middle age and the ubiquity of botulinum toxin type A, nonsurgical facial rejuvenation is becoming increasingly prevalent. As this generation continues to age, products with greater therapeutic power to correct aging changes will be in growing demand. A multicenter, double-blind, randomized, within-subject, controlled study was conducted comparing Juvéderm Ultra Plus hyaluronic acid filler with bovine collagen. A subset of subjects classified as having treatment for severe nasolabial folds is presented in this article. Subjects received Juvéderm Ultra Plus in one severe nasolabial fold and Zyplast collagen in the other nasolabial fold; up to two touch-up treatments were allowed at 2-week intervals. Nasolabial fold severity was evaluated every 4 weeks for 24 weeks using a five-point scale. Treatment site reactions and adverse events were also recorded. A complimentary treatment was offered at the end of the trial, with effectiveness evaluations just before retreatment and up to 48 weeks after repeated treatment for a subset of subjects. Of the 87 subjects, most were female Caucasians, but all Fitzpatrick skin types were represented (36 percent types IV through VI). At 24 weeks, 96 percent of nasolabial folds treated with Juvéderm had maintained clinically significant correction, and 81 percent maintained the correction for 1 year or more. Results were similar for those subjects with follow-up through 48 weeks after repeated treatment. The median volume required for repeated treatment with Juvéderm was significantly less than that for initial treatment (0.7 ml versus 1.6 ml). Juvéderm Ultra Plus provides correction of severe nasolabial folds through 1 year or more.

Juvéderm injectable gel: A multicenter, double-blind, randomized study of safety and effectiveness

A high concentration of crosslinked hyaluronic acid (HA) in a smooth, malleable formulation is the hallmark of the new Juvéderm dermal fillers. To determine the long-term effectiveness and safety of Juvéderm Ultra and Ultra Plus injectable gel. In the multicenter study approved by the Food and Drug Administration, subjects were randomized to treatment with Juvéderm Ultra or Ultra Plus in one nasolabial fold (NLF) and Zyplast collagen in the other. After optimal correction was achieved (treatment plus up to 2 touch-ups at 2-week intervals), effectiveness was assessed on a 5-point scale through the 6-month study period. An additional poststudy visit provided long-term effectiveness data. Safety was evaluated through subjects' daily diaries for 14 days after treatment. A total of 292 subjects were randomized and treated, 146 in each cohort. A total of 280 subjects completed the 6-month study, and 227 attended the poststudy visit. Clinically significant mean wrinkle correction (>or= 1 point improvement) was still in evidence at >9 months for both Juvéderm formulations but not for the Zyplast control. At >9 months, 75% of Juvéderm Ultra- and 81% of Juvéderm Ultra Plus-treated NLFs maintained a clinically significant correction. Moreover, 78% of NLFs treated with Juvéderm Ultra Plus still had a clinically significant improvement beyond 1 year. Local treatment site reactions were comparable for Juvéderm and Zyplast. These next-generation HA dermal fillers can be reliably expected to provide long-term correction, with Juvéderm Ultra lasting more than 9 months and Juvéderm Ultra Plus lasting for a year or more.

Occult Hepatitis B Virus Infection Among Blood Donors of North India

Background Hepatitis B virus (HBV) testing of blood donors in India is focused on the presence of HBsAg. However, the absence of HBsAg in the blood of the healthy individual may not be sufficient to ensure lack of circulating HBV. Aim The aim of this study is to estimate the prevalence of anti HBc and anti HBs pattern in anti HBc reactive but HBsAg negative blood donors. Material and Methods 6134 Blood donor samples were tested prospectively from 16th April to 7th July, 2007 for HbsAg and anti HBc (IgM + IgG) antibodies using BIORAD MONOLISA HbsAg ULTRA and BIO-RAD MONOLISA anti-HBc PLUS test kits. All the samples, which were negative for HbsAg but reactive for anti HBc, were tested for anti-HBs antibodies Using BIO-RAD MONOLISA ANTI HBs 3.0 test kits. Results Out of 6134 donor samples tested, 63 samples were HbsAg positive (1.02 %) and 499 samples (8.13%) showed anti HBc reactivity but HbsAg negative.195 (39.07%) out of 499 anti HBc positive samples showed levels of anti HBs above 15 IU/ml and 304 (60.92 %) showed levels of anti HBs below 15 IU/mL. The samples showing values above 15 IU/mL are considered positive and samples below 15 IU/mL are considered negative as per BIO-RAD MONOLISA anti HBs 3.0 instruction manual. Conclusion The data indicates that high percentage of blood donors (60.92%) were anti-HBc reactive and have low levels of preventive anti HBs antibodies. Accordingly all blood donor samples should be tested routinely for anti HBc and if the sera are reactive, regardless of anti-HBs titer, the blood should be discarded. Further testing for HBV-DNA is appropriate to follow up the blood donor for HBV infection.

Practical Use of Juv??derm: Early Experience

This article is intended to provide practical information on the use of Juvéderm Ultra and Juvéderm Ultra Plus injectable gel fillers and to highlight differences between the injection techniques and uses of these fillers and those of gel-particle suspensions. The author's purpose was to provide early information to clinicians who perform aesthetic surgery. The author discusses the properties of the Juvéderm family of products, compares these with particulate gel fillers, and makes recommendations for achieving optimal outcomes with Juvéderm as well as dermal fillers in general. When correcting relatively fine and superficial lines, or for first-time treatment of the lips, Juvéderm Ultra is preferred. Juvéderm Ultra Plus is useful for correction of deeper wrinkles and folds. Cohesive, homogenous gel fillers such as Juvéderm require gentle, gradual injection, which facilitates very accurate delivery to the site while minimizing the risk of disengagement of the needle from the Luer lock hub of the syringe. These fillers appear to remain in the desired location and do not flow away from the injection point into unintended areas, so that a somewhat smaller amount of filler is required for a given degree of correction. Both the Juvéderm preparations tend to blend in with the treated area in a shorter period of time compared with gel-particle suspensions. Finally, cohesive gels appear to be associated with a lesser degree of swelling in the 24-hour period after the procedure, particularly in the lips. Juvéderm Ultra and Juvéderm Ultra Plus are new-generation hyaluronic acid fillers used to treat superficial lines and deeper folds, respectively. They require administration by gentle, gradual, and precise injection.

Allergan Canada has launched two injectable hyaluronan products [Juv??derm Ultra and Juv??derm Ultra Plus] in Canada for the treatment of wrinkles,

Allergan Canada has launched two injectable hyaluronan products [Juv??derm Ultra and Juv??derm Ultra Plus] in Canada for the treatment of wrinkles,

O.116 Reasons for the lack of anti-HBC antibody detection in hepatitis B virus chronically infected patients

Hepatitis B virus (HBV) testing of blood donors in India is focused on the presence of HBsAg. However, the absence of HBsAg in the blood of the healthy individual may not be sufficient to ensure lack of circulating HBV.The aim of this study is to estimate the prevalence of anti HBc and anti HBs pattern in anti HBc reactive but HBsAg negative blood donors.6134 Blood donor samples were tested prospectively from 16th April to 7th July, 2007 for HbsAg and anti HBc (IgM + IgG) antibodies using BIORAD MONOLISA HbsAg ULTRA and BIO-RAD MONOLISA anti-HBc PLUS test kits. All the samples, which were negative for HbsAg but reactive for anti HBc, were tested for anti-HBs antibodies Using BIO-RAD MONOLISA ANTI HBs 3.0 test kits.Out of 6134 donor samples tested, 63 samples were HbsAg positive (1.02 %) and 499 samples (8.13%) showed anti HBc reactivity but HbsAg negative.195 (39.07%) out of 499 anti HBc positive samples showed levels of anti HBs above 15 IU/ml and 304 (60.92 %) showed levels of anti HBs below 15 IU/mL. The samples showing values above 15 IU/mL are considered positive and samples below 15 IU/mL are considered negative as per BIO-RAD MONOLISA anti HBs 3.0 instruction manual.The data indicates that high percentage of blood donors (60.92%) were anti-HBc reactive and have low levels of preventive anti HBs antibodies. Accordingly all blood donor samples should be tested routinely for anti HBc and if the sera are reactive, regardless of anti-HBs titer, the blood should be discarded. Further testing for HBV-DNA is appropriate to follow up the blood donor for HBV infection.

Poster 34: Incontinence Pads: Determining the Best Product Based on Different BMI

OBJECTIVE: To examine the difference in cost and wetback performance between brand name and generic pads in patients with BMI under 30 and over 30. METHODS: Eight different urinary incontinence pads were selected based on their commercial availability. A leak volume of 50 cc was selected to represent large leaks. A “leak” of tap water was spilled onto each pad. After a designated amount of time, 30 seconds or 5 minutes, a subject sat on the wet pad, covered by a piece of filter paper (representing a wearer's skin) finally covered by a plastic cover to protect the subject. The 2 largest axis of spread of the water onto the filter paper were then measured. These tests were performed with a subject with a BMI under 30 and 1 with a BMI over 30. RESULTS: Urinary incontinence products varied greatly in price per pad from 8 cents for panty-liners to over 72 cents for underwear with refastenable tabs. Larger products, Ultra Plus sizes, tended to do better with increased BMI, however this result was not statistically significant. Poise products also performed significantly better with increased BMI (30s, P=0.028, 5 min, P=0.027). Walgreen's Underwear did significantly worse than all other products tested at both BMIs (P=0.001–0.047) (Table 1). Depends Underwear did significantly worse than Walgreen's Ultra Plus for a 30 second wait to sit (P=0.021), and Poise Ultra Plus for a 5 min wait to sit (P=0.18) when the subject had a BMI >30.TABLE 1: Walgreen's Underwear Compared to Other Products TestedCONCLUSION: In general, brand name products performed better than generic products. There were significant differences in product performance with different BMI. Underwear products performed worse than other products and cost the most. Overall, the longer time the wearer waits to sit, the greater the absorption of the pad and therefore less moisture to the wearer's skin.

SPRAYER SPEED AND VENTURI–NOZZLE EFFECTS ON BROADCAST APPLICATION UNIFORMITY

Sprayer speeds up to ~26 kmh 1 did not reduce quantity or increase variation in field spray deposit across a 27.4mboom when using Ultra Plus Low Drift (UPLD) venturi nozzles at pressures of at least 276 kPa. Sprayer speeds of 12.9, 19.3,and 25.7 kmh 1 with the UPLD nozzles produced water sensitive paper coverage of ~19% that was not significantly differentthan the ~20% produced by an extended range (ER 4) single elliptical orifice nozzle. A 6.4 kmh 1 treatment with UPLD 15nozzles resulted in lower coverage (~14%) attributed to large droplets. Laser measured volume median diameters (Dv0.5 ) forthe UPLD 15, 2, 4, and 5 nozzles corresponding to sprayer speed treatments of 6.4, 12.9, 19.3, and 25.7 kmh 1 were 663, 474,579, and 513
m, respectively. The ER 4 nozzle produced a Dv0.5 of 187
m. UPLD nozzles resulted in spot densities rangingfrom 44.9 to 104.6 spot cm 2 , compared to 233.4 spot cm 2 for the ER 4, all at 93.5 Lha 1 spray rate. Overall, field appliedcoefficients of variation (CV) in deposit ranged from ~13% to 21% for all nozzles compared to ~4% to ~16% for a static spraypattern uniformity test. The static test determined an optimum nozzle height, based on minimization of CV, of 71 cm for UPLDnozzles. This was higher than 41 cm for the ER 4 nozzle. Slight nuances in coverage under nozzles versus between nozzles,between left, middle, and right boom were noted, including reduced coverage along the centerline of the sprayer for somespeed/nozzle combinations.