Safe and Effective Restoration of Jawline Definition With Hyaluronic Acid Injectable Gel VYC-25L: Results From a Randomized Controlled Study.

BACKGROUND: A well-defined jawline improves overall facial aesthetics, thus motivating patients to seek jawline augmentation. OBJECTIVES: This study will evaluate the safety and effectiveness of the hyaluronic acid injectable gel VYC-25L for restoring jawline definition. METHODS: A US multicenter, evaluator-blinded study randomized adults with grade 2 (moderate) or 3 (severe) Allergan Loss of Jawline Definition Scale (ALJDS) scores. Participants were randomized to VYC-25L treatment group or control group at study onset, with 12 months follow-up. The control group had the option to receive treatment after 6 months (primary endpoint completion). Effectiveness measures included month 6 ALJDS responders rate (proportion of participants with ≥1-grade improvement from baseline on both sides), FACE-Q Satisfaction With Lower Face and Jawline scores, and Global Aesthetic Improvement Scale (GAIS) responders (improved/much improved) as assessed by the investigator and participants. Injection site responses (ISRs) and adverse events (AEs) were monitored. RESULTS: At month 6, ALJDS responder rates were 69.0% versus 38.0% in the VYC-25L treatment (n = 157) and control (n = 49) groups, respectively (p = .0001). In the VYC-25L treatment group, FACE-Q scores improved by a mean of 45.9 points versus baseline at month 6 (p < .0001). Furthermore, 88.4% and 89.0% of participants in the VYC-25L treatment group were GAIS responders on month 6 by participant- and investigator-assessment, respectively. Most ISRs were mild or moderate and resolved within 2 weeks. Most treatment-related AEs were mild and resolved within a week. CONCLUSIONS: VYC-25L safely and effectively restores jawline definition through 1 year.

Safety and Efficacy of Polymethylmethacrylate-Collagen Gel Filler for Correction of the Pre-jowl Sulcus: A 24-month Prospective Study.

Background: Polymethylmethacrylate (PMMA)-collagen gel is approved for the correction of nasolabial folds and severe atrophic, distensible facial acne scars on the cheek. However, fillers are often used off-label in clinical practice, necessitating additional study of safety and efficacy. Objectives: To determine the safety and efficacy of PMMA-collagen gel for the correction of lower face aging, specifically the pre-jowl sulcus. Methods: In this prospective, single-center, 1-year study (N = 20) and additional 1-year extension (N = 10), 20 patients with a pretreatment score of 2, 3, or 4 on the 5-point Merz Aesthetic Scale for jawline at rest were eligible for treatment with PMMA-collagen gel. Efficacy was measured by blinded review using the jawline scale, Subject and Physician Global Aesthetic Improvement Scale (GAIS) and Subject Satisfaction scores, collected at weeks 4, 12, 26, 52, and 104. Results: Improvement in jawline score was significant at all posttreatment time points up to 104 weeks (P < 0.01). The percentage of patients with subject-reported GAIS ratings of "improved" or "much improved" was 79% at 12 weeks and ratings were maintained at 76% at 52 weeks and increased to 90% at week 104. At 52 and 104 weeks, 82% and 100% of patients, respectively, were at least "somewhat satisfied." All adverse events were minor. Conclusions: PMMA-collagen gel is well tolerated and effective for durable correction of the pre-jowl sulcus and jawline.

Safety and efficacy of a cohesive polydensified matrix hyaluronic acid for the correction of infraorbital hollow: an observational study with results at 40 weeks.

BACKGROUND: Utilizing a soft-tissue filler that is more fluid and less resistant to deformation may be advantageous for correction of infraorbital hollows. OBJECTIVE: The objective of this study was to determine the safety and efficacy of the latest hyaluronic acid filler, created with a cohesive polydensified matrix, with a low elasticity and viscosity, for infraorbital hollows correction. METHODS AND MATERIALS: Subjects (49) with at least a grade 2 Merz infraorbital hollow scale in the Validated Assessment Scales for the mid face (0-4) of the right and/or left side were photographed and treated at baseline, and with a touch up treatment after 2 weeks if necessary. Subjects were also photographed at 2, 6, and 10 months after baseline, with optional retreatment at 6 months. The photographs were graded by a blinded sub-investigator. RESULTS: Mean hollowness scores for both eyes, either individually or combined, at 2, 6, and 10 months were considerably improved compared to baseline (P<.001). No serious adverse events were reported. Of the 46 subjects completing the study, 31 (66%) did not request retreatment after 6 months. At 10 months, 27/31 (87%) still exhibited a hollowness improvement of at least 1-point from baseline. CONCLUSION: Belotero Balance was safe and effective for the correction of infraorbital hollows.

Retrospective review of 500 patients treated with abobotulinumtoxinA.

BACKGROUND: Prior international clinical experience and domestic controlled clinical trials provide useful guidance for dosing of a new botulinum toxin type A, abobotulinumtoxinA. Nonetheless, aftermarket experience is paramount in providing confirmatory "real world" information on any recently introduced drug. This report describes the incorporation of abobotulinumtoxinA into an established clinical practice that previously only utilized onabotulinumtoxinA for facial rejuvenation. DESCRIPTION: Retrospective review of 500 patients who received abobotulinumtoxinA injections. RESULTS: A total of 736 abobotulinumtoxinA treatments were administered to 500 patients. The most common areas treated were corrugators, "crow's feet", frontalis, brow and platysma, respectively. A dose conversion ratio of 1:2.67 (onabotulinumtoxinA: abobotulinumtoxinA) was determined. The majority of adverse events were considered to be mild and self-limiting. There were three (0.6%) cases of ptosis. CONCLUSION: Since its recent approval by the U.S. Food and Drug Administration (FDA), experience with abobotulinumtoxinA is evolving. Utilizing a dose conversion ratio of 1:2.67 units (onabotulinumtoxinA: abobotulinumtoxinA) and the same injection techniques, one can safely and effectively incorporate this new neurotoxin into his or her practice.

Six-year experience using 1,000-centistoke silicone oil in 916 patients for soft-tissue augmentation in a private practice setting.

BACKGROUND: There are no previously published reports focusing exclusively on the use of 1,000-centistoke purified polydimethylsiloxane (PDMS-1000) for cosmetic soft-tissue augmentation. OBJECTIVE: To provide clinical experience with its cosmetic use, solely and in conjunction with other nonpermanent fillers, in a private practice setting. METHODS AND MATERIALS: A retrospective chart review was conducted for patients treated by the author over 6 years, beginning in 2003. Treatments were tabulated according to facial region and arbitrarily designated as rhytides, acne scars, lips, infraorbital, nasolabial, and general contour. Therefore, up to six treatments were possible with any visit. Concomitant treatment with nonpermanent fillers, as well as any significant adverse events, was noted as well. RESULTS: Nine hundred sixteen patients were treated (816 (89%) female, 100 (11%) male). There were 5,246 treatments over 3,307 visits, with an average of 3.5 visits per patient and 1.6 treatments per visit. Adverse events were limited to overcorrection in 11 patients (1%). Of the 916 patients, 257 (28%) were also treated with other (nonpermanent) fillers without incident. CONCLUSION: Over the 6-year period, PDMS-1000 was found to be effective and safe in the cosmetic practice setting. Other (nonpermanent) fillers were also used without incident.

A retrospective review of calcium hydroxylapatite for correction of volume loss in the infraorbital region.

BACKGROUND: The correction of infraorbital volume loss with dermal fillers results in a natural, youthful, rested appearance. Defects in this facial region should be treated for optimal patient satisfaction. OBJECTIVE: This retrospective review describes large-scale use of injection of calcium hydroxylapatite (CaHA) and a technique for injection into the infraorbital region. METHODS AND MATERIALS: Using a 30-gauge, 0.5 needle, CaHA was injected into the infraorbital region of 301 patients. Neat CaHA was initially twice diluted with lidocaine 2% solution in 85 patients. Subsequently, 216 patients were treated with single-dilution CaHA and 0.15 mL of 2% lidocaine. RESULTS: Injection of CaHa through a 30-gauge, 0.5 needle resulted in minimal bruising, discomfort, or pain. Infraorbital volume restoration was achieved efficiently and effectively, with natural results. Patients were satisfied with the longevity of correction. Adverse events were few and confined to ecchymosis (10%), edema (2%), and erythema (1%). Three of six patients reported edema lasting beyond 7 days. No overcorrection was observed. CONCLUSION: Using a 30-gauge, 0.5 needle, diluted CaHA can be safely injected into the infraorbital region with minimal adverse events and high patient satisfaction.

Effective treatment of actinic keratosis with 0.5% fluorouracil cream for 1, 2, or 4 weeks.

New therapeutic options would benefit patients with actinic keratosis (AK), a precancerous condition that is a significant health concern. The efficacy and safety of a microsphere-based formulation of 0.5% fluorouracil cream were evaluated in a randomized, double-blind, multicenter, parallel-group study. Patients (N= 177) were randomized to receive 0.5% fluorouracil or vehicle once daily for 1, 2, or 4 weeks. Efficacy was assessed by lesion counts and clearance. Safety was evaluated by monitoring adverse events, including facial irritation. Significant improvements were seen from baseline to posttreatment follow-up in all efficacy variables for all fluorouracil regimens compared with vehicle. Patients treated for one week experienced significant improvements compared with vehicle, although efficacy increased with increasing treatment duration. Most patients experienced mild to moderate facial irritation of predictable onset and duration. Once-daily administration of 0.5% fluorouracil cream for 1, 2, or 4 weeks is safe and effective for the treatment of AKs.