Ultrastructural analysis of 3 hyaluronic acid soft-tissue fillers using scanning electron microscopy.

BACKGROUND: Although hyaluronic acid (HA) specifications such as molecular weight and particle size are fairly well characterized, little information about HA ultrastructural and morphologic characteristics has been reported in clinical literature. OBJECTIVE: To examine uniformity of HA structure, the effects of extrusion, and lidocaine dilution of 3 commercially available HA soft-tissue fillers. MATERIALS AND METHODS: Using scanning electron microscopy and energy-dispersive x-ray analysis, investigators examined the soft-tissue fillers at various magnifications for ultrastructural detail and elemental distributions. RESULTS: All HAs contained oxygen, carbon, and sodium, but with uneven distributions. Irregular particulate matter was present in RES but BEL and JUV were largely particle free. Spacing was more uniform in BEL than JUV and JUV was more uniform than RES. Lidocaine had no apparent effect on morphology; extrusion through a 30-G needle had no effect on ultrastructure. CONCLUSION: Descriptions of the ultrastructural compositions and nature of BEL, JUV, and RES are helpful for matching the areas to be treated with the HA soft-tissue filler architecture. Lidocaine and extrusion through a 30-G needle exerted no influence on HA structure. Belotero Balance shows consistency throughout the syringe and across manufactured lots.

A Randomized, Blinded Study to Validate the Merz Hand Grading Scale for Use in Live Assessments.

BACKGROUND: The Merz Hand Grading Scale (MHGS) is a 5-point scale used to grade appearance of the dorsum of the hand. The MHGS has been previously validated for assessment of photographed hands but not for live assessment. OBJECTIVE: The purpose of this randomized, blinded study was to validate the MHGS for live assessment of the hands in the clinical setting. METHODS: Three physician raters completed a scale qualification program that included MHGS training, ratings of standardized hand photographs, and statistical analysis for reliability. Eighty-four subjects (28 males, 30% Fitzpatrick skin Types IV-VI, mean age of 42 years), randomized to 2 live assessment sessions for independent and blinded observation of dorsa of their right hands, completed the study. RESULTS: Overall MHGS intrarater weighted Kappa value was 0.74 (0.68-0.79 [CI 95%]). First- and second-time hand-rating agreement scores ranged from 64% to 75%. Interrater weighed Kappa values ranged from 0.59 to 0.71, representing between-rater paired results of each combination of raters. CONCLUSION: High-weighted Kappa values and agreements demonstrate that consistency at different time points can be achieved individually and by different raters for live assessments. The MHGS is a suitable instrument for live assessment in the clinical setting.

A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine.

BACKGROUND: Hyaluronic acid (HA) fillers are sometimes mixed with lidocaine to mitigate pain. Whether the addition of epinephrine to lidocaine provides greater benefits in bruising and pain has not been fully reported. OBJECTIVES: The investigators explored the severity of bruising and pain in patients treated with the cohesive polydensified matrix HA (CPMHA) in 3 different preparations: CPMHA (Belotero Balance [BEL]), CPMHA with lidocaine (BEL-L), and CPMHA with lidocaine and epinephrine (BEL-LE). METHODS: In a blinded, split-face, 14-day study, 30 patients were divided into groups of 10. One group received 1.0 mL BEL in the perioral lines on 1 side and 1.0 mL of BEL-LE on the other side. A second group received 1.0 mL of BEL on 1 side and 1.0 mL of BEL-L on the other side. The third group received 1.0 mL of BEL-L on 1 side and 1.0 mL of BEL-LE on the other side. Over 3 visits, the treating investigator, the patients, and a blinded investigator rated the bruising. RESULTS: Bruising occurred in each treatment group by day 1 but resolved for half of the patients by day 7 and for all patients by day 14. Split-face comparison did not reveal a significant difference in pain and bruising scores among the 3 preparations. CONCLUSIONS: No significant difference was found in bruising or pain in patients treated with BEL, BEL-L, and BEL-LE. Studies with a considerably larger sample size are warranted to determine statistically significant and clinically meaningful differences between and among the various formulations.

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.

A prospective, split-face, randomized, comparative study of safety and 12-month longevity of three formulations of hyaluronic acid dermal filler for treatment of nasolabial folds.

BACKGROUND: Data regarding several hyaluronic acids (HAs) used identically for facial tissue augmentation have heretofore been unavailable. OBJECTIVES: This prospective, split-face, randomized, two-armed study sought to determine the long-term safety and effectiveness of three HAs (HA-1 (Belotero Basic/Balance), HA-2 (Restylane), and HA-3 (Juvéderm Ultra 3/Juvéderm Ultra Plus XC) in the treatment of nasolabial folds (NLFs). METHODS: Twenty participants in Arm A received HA-1 in one NLF and HA-2 in the other. In Arm B, 20 participants received HA-1 in one NLF and HA-3 in the other. Injection was at visit 2, with follow-up visits at 1, 6, 9, and 12 months. Mean volume of HA was slightly <1.5 mL/NLF. RESULTS: Adverse events were unremarkable across all HAs, with injection site erythema being the most frequent adverse event. Mean pretreatment NLF severity rating for both arms was 2.3; at 12 months, mean posttreatment severity rating was 1.5 for HA-1/HA-2 and 1.6 for HA-1/HA-3. Although not statistically significant, participants tended to show a preference for HA-1. CONCLUSION: All three HAs provided essentially equivalent results, except for 4-week evenness results, which favored HA-1. Injection volumes of the three HAs were also similar.

Physician and patient satisfaction after use of calcium hydroxylapatite for cheek augmentation.

BACKGROUND: Initial applications of calcium hydroxylapatite (CaHA) focused on filling lines and wrinkles. Facial volumization with CaHA has not been fully explored. OBJECTIVE: The purpose of this large scale, prospective, randomized, controlled, multicenter study was to assess CaHA for cheek volumizing, including physician and patient satisfaction. METHODS: Subjects ( N = 116) were randomized to an immediate treatment group or to an untreated control group (crossed over at 3 months). Patients received CaHA injections in their cheeks, defined as the malar, submalar, zygoma, preauricular, and infraorbital areas. Assessments of quantitative changes in cheek volume using magnetic resonance imaging analysis, qualitative assessments by masked evaluators, and physician and patient satisfaction analyses were also performed, including overall satisfaction with aesthetic results and likelihood to return for future treatments. Safety was assessed across 12 months. RESULTS: Mean total treatment volume (107 patients) was 4.7 mL of CaHA. At all points, physicians reported satisfaction of 75% or more, with 92% satisfaction at 12 months. Most patients also reported being satisfied at all time points, with 80% satisfied at 12 months. No serious adverse events occurred. CONCLUSION: Midface volumizing with CaHA results in high physician and patient satisfaction up to 12 months from treatment.

Five-year retrospective review of safety, injected volumes, and longevity of the hyaluronic acid Belotero Basic for facial treatments in 317 patients.

BACKGROUND: Hyaluronic acids (HA) fillers abound in the European community, many with different names in different countries. One such HA is Belotero Basic, recently approved by the FDA in the United States. OBJECTIVE: The objective of this article is to report on use of this HA in a German clinic, over a period of 5+ years, in 317 patients (668 treatments). METHODS AND MATERIALS: Authors retrospectively examined patient charts of 317 patients (312 females), aged 24 to 87 years. Chart review showed areas treated, range of volumes per area, and mean volumes. Patient satisfaction data was collected anecdotally over the five years. RESULTS: Volumes of the HA injected ranged from 0.2 mL to 3.0 mL, depending on the area being treated. No serious adverse events were noted in the chart review, nor was any Tyndall effect observed in the treated areas. Anecdotal information suggests high patient satisfaction with results, based on the return of these patients to the clinic for other treatments over the more than five years. CONCLUSION: Belotero Basic provides aesthetically pleasing results for treatment of facial defects, without carrying a risk of serious adverse events. North American physicians now have a new HA to consider as part of their treatment protocols.

Absence of concentration congruity in six compounded polidocanol samples obtained for leg sclerotherapy.

BACKGROUND: In the arena of venous sclerotherapy, sodium tetradecyl sulfate (STS), hypertonic saline, and polidocanol (POL) are the most widely used agents in the world for treating endothelial vein wall destruction. Pharmaceutical-grade STS and hypertonic saline are available from manufacturers. Until 2010, POL was only available in the United States through compounding pharmacies. OBJECTIVE: To identify whether a risk exists when using freely available compounded POL samples for venous sclerotherapy. MATERIALS AND METHODS: Six samples of 1% POL solutions obtained from four compounding pharmacies were evaluated using gas chromatography mass spectrometry (GC/MS) assays for POL concentration and identification of material impurities. RESULTS: Disparities in POL concentrations between six samples ranged from 1.0% to 3.1%. The GC/MS analysis showed impurities in all six compounded POL samples. CONCLUSIONS: In this study, compounded POL solutions did not deliver the claimed concentration five out of six times. This inconsistency poses risks to the patient and the treating physician during venous sclerotherapy with pharmacy-compounded POL. Merz Aesthetics provided funding for this study.

A multicenter, randomized trial comparing calcium hydroxylapatite to two hyaluronic acids for treatment of nasolabial folds.

INTRODUCTION: In this study, we examined Radiesse (calcium hydroxylapatite; CaHA), Juvederm 24 (hyaluronic acid; HA-1A), Juvederm 24HV (HA-1B), and Perlane (HA-2) for patient satisfaction, likelihood to return, immediate efficacy, and duration of correction. OBJECTIVE: This multicenter, blinded, randomized study compares patient satisfaction variables, efficacy, and durability of CaHA gel and HA for correction of nasolabial folds (NLFs) through 12 months after 4-month touch-up. METHODOLOGY: A total of 205 randomized patients received either CaHA gel or HA for NLF treatment at initial visit and 4-month touch-up. Patients returned at 4, 8, and 12 months after the second injection for evaluation. Surveys measured patient satisfaction; effectiveness measures included the Global Aesthetic Improvement Scale (GAIS). RESULTS: More CaHA gel patients were satisfied or extremely satisfied than each HA tested. At 8 months, significantly more CaHA gel-treated NLFs were improved on the GAIS than any HA. The volumes of CaHA gel and three HA materials injected through 4 months were 2.2, 2.9, 4.8, and 2.9 mL, respectively (p<.005). No serious adverse events were observed. CONCLUSIONS: In this controlled study, CaHA gel ranked highest in patient satisfaction and likelihood to return. The material was more effective and longer lasting than each HA in maintaining NLF augmentation.