Efficacy and safety of a hyaluronic acid filler in subjects treated for correction of midface volume deficiency: a 24 month study.

BACKGROUND: Hyaluronic acid (HA) fillers are an established intervention for correcting facial volume deficiency. Few studies have evaluated treatment outcomes for longer than 6 months. The purpose of this study was to determine the durability of an HA filler in the correction of midface volume deficiency over 24 months, as independently evaluated by physician investigators and subjects. METHODS: Subjects received treatment with Juvéderm(™) Voluma(™) to the malar area, based on the investigators' determination of baseline severity and aesthetic goals. The treatment was administered in one or two sessions over an initial 4-week period. Supplementary treatment was permissible at week 78, based on protocol-defined criteria. A clinically meaningful response was predefined as at least a one-point improvement on the MidFace Volume Deficit Scale (MFVDS) and on the Global Aesthetic Improvement Scale (GAIS). RESULTS: Of the 103 subjects enrolled, 84% had moderate or significant volume deficiency at baseline. At the first post-treatment evaluation (week 8), 96% were documented to be MFVDS responders, with 98% and 100% graded as GAIS responders when assessed by the subjects and investigators, respectively. At week 78, 81.7% of subjects were still MFVDS responders, with 73.2% and 78.1% being GAIS responders, respectively. Seventy-two subjects completed the 24-month study, of whom 45 did not receive supplementary Voluma(™) at week 78. Forty-three of the 45 (95.6%) subjects were MFVDS responders, with 82.2% and 91.1% being GAIS responders, respectively. At end of the study, 66/72 subjects were either satisfied or very satisfied with Voluma(™), with 70/72 indicating that they would recommend the product to others. Adverse events were transient and infrequent, with injection site bruising and swelling being the most commonly reported. CONCLUSION: Voluma(™) is safe and effective in the correction of mild to severe facial volume deficiency, achieving long-term clinically meaningful results. There was a high degree of satisfaction with the treatment outcome over the 24 months of the study.

An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study.

OBJECTIVE: There are limited controlled data for intragastric balloons (IGB) in obesity treatment. This randomized, controlled study evaluated the efficacy and safety of an IGB in obese individuals with metabolic syndrome (MS). DESIGN AND METHODS: Sixty-six adults (BMI: 30-40 kg/m(2)) were randomized to IGB for 6 months, with a 12 month behavioral modification (IGB Group; "IGBG"), or 12 month behavioral modification alone (Control Group; "CG"). The primary outcome was percentage change in body weight. RESULTS: Thirty-one subjects (female: 68%; mean age: 43; mean BMI: 36.0) were randomized to IGBG and 35 (66%; 48; 36.7) to CG. At 6 months, there was a significantly greater weight loss in the IGBG: -14.2 vs. -4.8; P < 0.0001. This was associated with a significantly greater reduction in waist circumference, and an improvement in quality of life, with a trend for a larger %MS remission (50% vs. 30%; n.s.). At month 12, the differences in weight loss were enduring: -9.2 vs. -5.2; P = 0.007. Gastrointestinal-related adverse events were common in the IGBG, resolving predominantly within two weeks. The IGB was removed prematurely in three subjects (one for refractory gastrointestinal symptoms). CONCLUSIONS: Statistically significant and clinically relevant improvements in weight loss and health outcomes were observed with the IGBG at 6 months versus behavioral modification alone. The differential weight loss was still evident 6 months after IGB removal.

A software program designed to educate patients on age-related skin changes of facial and exposed extrafacial regions: the results of a validation study.

BACKGROUND: A software program called "HOYS" has been developed to depict various aspects and degrees of aging at 35 constituent subregions of seven distinct facial or exposed extrafacial regions. This program is underpinned by five-point photonumeric Likert scales characterizing skin surface and volume changes across five decades for each of the 35 subregions, and features an interactive skin-age assessment with a treatment-prioritization tool. In this study, the reliability and reproducibility of these scales was evaluated. METHODS: Eleven physicians and 19 non-physicians participated in this study. The five images from each of the 35 Likert scales in the HOYS program were shown on a total of 43 display boards, with selected subregions presented at rest or with movement, consistent with this program. Each image was randomly labeled between "A-E," corresponding to a range of skin ages by decade from 20-69 years. Each rater was asked to rank these images from youngest to oldest (or least to most severe deficit) for each scale and to repeat this exercise 2 hours later, with the intra- and inter-rater reliability evaluated. The raters were also asked to estimate the age of a single randomly allocated image on each scale for the purposes of internal validation. RESULTS: The overall inter-rater reliability of the raters was high at the first ranking session (weighted kappa: 0.78; 95% confidence intervals [95% CI]: 0.77-0.79) and this was confirmed when repeated 2 hours later (0.82; 95% CI: 0.81-0.83), with an intra-rater reliability of 0.76 (95% CI: 0.75-0.77). There was no significant difference in the physicians' and non-physicians' rankings. The raters also accurately estimated the actual age of the single randomly allocated image from each of the 43 stations (0.72; 95% CI: 0.70-0.74). A very similar pattern was observed when the ratings of a constituent of one of the seven regions, the perioral/lower face, were analyzed for expounding purposes. CONCLUSION: The high reliability and reproducibility of the ranking in this validation study suggests that the five-point photonumeric Likert scales used in the HOYS program are an accurate depiction of age-related changes over five decades in the seven facial and extrafacial regions represented in this program, from the ages of 20-69 years.

Patient's self-evaluation of two education programs for age-related skin changes in the face: a prospective, randomized, controlled study.

BACKGROUND: An interactive software program (HOYS) has been developed utilizing a database of digital images depicting various aspects and degrees of aging of exposed skin across seven geographic regions, representing a total of 35 facial and extrafacial subregions. A five-point photonumeric rating scale, which portrays age-related skin changes across five decades for each of these subregions, underpins this patient-based interactive self-assessment program. Based on the resulting outputs from this program, an individualized treatment prioritization list is generated for each region where significant differences between the patient's chronological and esthetic ages exist. This provides guidance for the patient and the treating physician on treatment options. METHODS: To evaluate the utility of HOYS in the clinic, relative to education programs currently used in Australian private esthetic clinics, a total of 95 esthetically-orientated patients were enrolled in a prospective, randomized, controlled, multicenter study. RESULTS: Compared with a prospective cohort of patients completing a standard education program commonly utilized in Australian esthetic clinics, patients receiving the HOYS education program reported greater empowerment through improved knowledge of specific age-related skin changes. This was associated with a clearer understanding of treatment options available to them, and a perceived ability to participate in the selection of the treatments potentially administered to improve their appearance. These differences between the two education groups were highly significant. CONCLUSION: Patients completing the HOYS patient education program have an improved understanding of age-related changes to exposed skin of their face, neck, décolletage, and hands. Due to the patient-specific nature of the program, these patients perceive a greater role in the deciding which esthetic treatments should be subsequently administered to enhance their appearance, through an improved understanding of the rationale for these treatments and indeed how they should be prioritized to achieve the best outcome for them.

A comparison of the efficacy, safety, and longevity of two different hyaluronic acid dermal fillers in the treatment of severe nasolabial folds: a multicenter, prospective, randomized, controlled, single-blind, within-subject study.

BACKGROUND: Commercially available hyaluronic acid (HA)-based fillers have distinct physicochemical properties related to their specific manufacturing technology, including HA concentration, cross-linking percentage, and particle size. These factors may determine treatment effectiveness, safety, and longevity; however, this requires confirmation in the clinic. METHODS: To compare the efficacy, safety, and longevity of two distinct HA-based dermal fillers in the correction of severe nasolabial folds (NLFs), a 24 mg/mL smooth gel (Juvederm ULTRA PLUS™ [JUP]) and a 20 mg/mL particulate gel (Perlane(®) [PER]) were injected in a total of 80 normal, healthy subjects using a split face design and were followed for 12 months in this prospective, randomized, controlled, multicenter study. RESULTS: Both fillers achieved a clinically relevant NLF correction (one point or more improvement, based on a validated NLF severity scale). However, JUP displayed greater longevity, with this correction maintained in a significantly larger percentage of NLFs after 6 months (physician's evaluation) or 9 months (subject's evaluation) and thereafter for the remainder of the study (70% vs 45%; P = 0.0002 and 62.5% vs 46.3%; P = 0.01 at month 12, based on physician and subject assessments, respectively). At month 12, 71.4% of the subjects nominated a preference for the NLF injected with JUP (P < 0.0001). Both treatments were well tolerated. CONCLUSION: These results suggest that different physicochemical properties of HA-based fillers, associated with distinct manufacturing technologies, may influence treatment longevity in the correction of volume deficits. This may relate to a differential resistance to hyaluronidase and/or free radical degradation as previously documented in vitro.