Juvederm ultra for lip enhancement: an open-label, multicenter study.

BACKGROUND: Juvéderm Ultra injectable gel (Allergan, Inc, Irvine, California) is approved in the United States to treat moderate to severe wrinkles and folds, such as nasolabial folds. It is also used to enhance the appearance of the lips. OBJECTIVES: The authors evaluated the safety and effectiveness of Juvéderm Ultra injectable gel for lip enhancement and assessed the utility of 3 new lip-specific effectiveness scales. METHODS: In this multicenter study, 50 subjects received lip enhancement with Juvéderm Ultra injectable gel. The subjects were observed closely by the treating investigator and results were evaluated by a blinded independent rater and by subject self-assessment for up to 48 weeks to determine the durability of the effects. A validated lip fullness scale (LFS) was used for analysis. Treatment satisfaction was assessed by investigators and subjects using an 11-point scale. RESULTS: At week 12, 71% of subjects had achieved their goals for lip fullness and had maintained improvement of at least 1 grade on the LFS, which greatly exceeded the a priori criterion of 40% for success. At week 24, improvement in lip fullness was still present for 56% of subjects. Satisfaction and goal achievement exceeded 90% for subjects as well as investigators. Common side effects were predominantly mild or moderate in intensity and resolved within 1 week in the majority of subjects. CONCLUSIONS: Juvéderm Ultra injectable gel is safe and effective for lip enhancement. Scales for assessing lip fullness provide an objective method to determine the effectiveness of treatment.

Duration of wrinkle correction following repeat treatment with Juvéderm hyaluronic acid fillers.

Many patients elect to have repeat treatments with hyaluronic acid dermal fillers to maintain wrinkle correction, but the clinical performance of these products after repeat treatments has not been formally assessed. The primary objective of this study was to evaluate the effectiveness of Juvéderm injectable gel (Juvéderm Ultra, Juvéderm Ultra Plus, and Juvéderm 30) through 1 year after repeat treatment of nasolabial folds (NLFs) that were previously treated with Juvéderm or Zyplast 6-9 months prior to the repeat treatment. Upon completion of the pivotal IDE clinical trial for Juvéderm, five of the original 11 study sites were selected to participate in an extended follow-up evaluation, and a total of 80 subjects were enrolled. For the Juvéderm-treated NLFs in each treatment group, the median injection volume was 1.5-1.6 mL for initial treatment but only 0.5-0.6 mL for the repeat treatment (p < 0.0001). Mean Investigator-assigned NLF severity scores on a scale of 0-4 for the Juvéderm-treated NLFs improved from 2.5-2.7 (moderate to severe) at baseline to 1.2-1.5 (mild) just prior to repeat treatment (>24 weeks) and 0.7-0.9 (mild) at 4 weeks after repeat treatment. At 48 weeks post-repeat treatment, the mean NLF scores were 1.1-1.3 (mild), and 78-90% of subjects were considered responders (≥1 point improvement). Thus, subjects sustained a total of 18-21 months of wrinkle correction with a repeat treatment at 6-9 months and needed substantially less filler (60% less) for repeat treatment than for initial treatment, indicating that retreatment at this timepoint may be beneficial to patients.

Safety and effectiveness of hyaluronic acid fillers in skin of color.

OBJECTIVES: To assess the safety and effectiveness of hyaluronic acid (HA) fillers in skin of color. METHODS: Two prospective studies followed up subjects with Fitzpatrick skin phototypes of IV, V, or VI for 24 weeks after dermal filler injections. In a double-blind, randomized study, subjects were injected with one of three high concentration (24 mg/mL) HA fillers (Juvéderm Ultra, Ultra Plus, and 30) in one nasolabial fold and Zyplast collagen in the other. In an open-label, randomized study, subjects received one of three low concentration (5.5 mg/mL) HA fillers (Hylaform, Hylaform Plus, and Captique) in both nasolabial folds. RESULTS: A total of 160 subjects (a subset of 439 study subjects) were randomized and treated with one of the three high concentration fillers, and 119 subjects were randomized and treated with one of the three low concentration fillers. For subjects treated with the high concentration fillers there were no occurrences of hypersensitivity or hypertrophic scarring, and no increased incidence of hyperpigmentation or hypopigmentation in non-Caucasian vs. Caucasian subjects. For subjects treated with the low concentration fillers there were no occurrences of keloid formation, hypertrophic scarring, hypopigmentation, hypersensitivity, and three instances of mild hyperpigmentation. For all of the fillers the majority of subjects maintained >/=1 point improvement in nasolabial fold severity scores through 24 weeks. CONCLUSIONS: All of the HA fillers were well tolerated in individuals with skin of color and demonstrated effectiveness throughout the 24 week period. Furthermore, the fillers provided smooth, natural-looking wrinkle correction in darker skin types.

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

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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

BACKGROUND: A high concentration of crosslinked hyaluronic acid (HA) in a smooth, malleable formulation is the hallmark of the new Juvéderm dermal fillers. OBJECTIVE: To determine the long-term effectiveness and safety of Juvéderm Ultra and Ultra Plus injectable gel. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Effectiveness of Juvéderm Ultra Plus dermal filler in the treatment of severe nasolabial folds.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSION: Juvéderm Ultra Plus provides correction of severe nasolabial folds through 1 year or more.

Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study.

BACKGROUND: A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers was approved by the FDA in June 2006. Compared with other HA fillers available in the United States at the time of writing, these new fillers have a higher concentration of HA, higher concentration of cross-linked HA, and a smooth consistency--which should promote long-lasting corrections and a smooth, natural look and feel postinjection. OBJECTIVE: The objective was to compare the effectiveness and safety of these smooth-gel HA dermal fillers with bovine collagen for nasolabial fold (NLF) correction. METHODS AND MATERIALS: A total of 439 subjects with moderate or severe NLFs received one of three types of smooth-gel HA dermal filler (in one NLF) and cross-linked bovine collagen (in the other NLF) and were evaluated for or=6 months. Up to 88% of subjects preferred the HA dermal fillers over bovine collagen. All fillers were similarly well tolerated. CONCLUSION: The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagen-which may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vast majority of subjects-which should promote patient satisfaction.

Development of a novel nonantigenic dermal implant composed of human placental collagen.

Injectable bovine collagen has proven to be safe and effective for the treatment of contour defects for more than 20 years. After intradermal exposure to bovine collagen, the most commonly reported side effect is hypersensitivity (incidence of approximately 3 percent to test and approximately 1 to 2 percent to subsequent treatment). The main purpose of this study was to evaluate tissue response and antibody production in bovine collagen-sensitive patients who were treated with human collagen (predominantly type I) implant. Twenty-seven patients with confirmed hypersensitivity to bovine collagen received a depot of human collagen implant and then were treated for facial contour defects on two to five separate occasions over a 9- to 12-month period and followed through 36 months. Measurement of antibody titers indicated that none of the subjects receiving human collagen implant developed antibodies against human collagen, even in the presence of positive antibody titers against bovine collagen. Histologic examination of the depot sites in these patients showed only mild inflammation. These findings indicate that treatment with human collagen did not elicit an allergic response in these subjects who had confirmed hypersensitivity to bovine collagen.