Current aesthetic use of abobotulinumtoxinA in clinical practice: an evidence-based consensus review.

The amount and complexity of scientific and clinical evidence for aesthetic use of botulinum neurotoxin type A (BoNT-A) has expanded rapidly in recent years, especially for abobotulinumtoxinA, necessitating reassessment of current knowledge about aesthetic use of abobotulinumtoxinA and other BoNT-A preparations. A committee of 13 plastic surgeons, facial plastic surgeons, and dermatologists engaged in a live discussion of information from a systematic literature review and an Internet-based survey of their beliefs and practices. The committee achieved consensus on most issues. It was concluded that doses of different BoNT-A preparations cannot be interconverted with a fixed ratio. The size of the "field of effect" is difficult to measure, and comparisons between preparations have yielded equivocal results. Nonresponse due to neutralizing antibodies appears exceedingly rare with currently available BoNT-A preparations and of little concern clinically. BoNT-A dose, injection depth, and injection technique should be adjusted according to the anatomic area being treated and each patient's individual characteristics and goals. Aesthetic use of BoNT-A has a good safety profile. Most adverse events are minor and related to the trauma of injection, although special care is needed in certain anatomic areas. Detailed recommendations for treatment of different anatomic areas are presented. BoNT-A products are often used in conjunction with other treatment modalities (eg, fillers and resurfacing), but little agreement was reached on best practices. The findings reported in this consensus document may serve as a practical guide for aesthetic practitioners as they apply the latest knowledge about BoNT-A in providing their patients with optimal care.

Safety and tolerability of high-intensity focused ultrasonography for noninvasive body sculpting: 24-week data from a randomized, sham-controlled study.

BACKGROUND: High-intensity focused ultrasonography (HIFU) is a nonsurgical, noninvasive method for body sculpting in nonobese patients. The technique ablates subcutaneous adipose tissue by causing molecular vibrations that increase tissue temperature and induce rapid cell necrosis. OBJECTIVES: The authors evaluate the long-term safety of a HIFU device for sculpting the abdomen and flanks. METHODS: Adults with subcutaneous abdominal fat ≥2.5 cm in thickness who met screening criteria were randomized to receive HIFU treatment of the anterior abdomen and flanks at 1 of 3 energy levels (3 passes per patient): 47 J/cm(2) (141 J/cm(2) total), 59 J/cm(2) (177 J/cm(2) total), or 0 J/cm(2) (no energy applied; sham control). Safety was assessed for 24 weeks and included laboratory testing, physical examinations, and documentation of adverse events. RESULTS: Adverse events (AE) included mild to moderate discomfort, ecchymosis, and edema, all of which were transient. There were no reports of scarring or burns and no clinically meaningful changes in lipid panel findings, inflammatory markers, or renal or hepatic function. Physical examination results were unremarkable. CONCLUSIONS: This HIFU device exhibited an AE profile similar to that of sham treatment. There were no significant changes from baseline in laboratory values, including lipid levels.

A randomized, evaluator-blinded, controlled study of the effectiveness and safety of small gel particle hyaluronic acid for lip augmentation.

OBJECTIVES: To assess the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for lip augmentation. METHODS: Adults (n = 180; aged 18-65) scoring 1 (very thin) to 2 (thin) on the 5-point validated Medicis Lip Fullness Scale (MLFS) for the upper or lower lip were randomized (3:1) to SGP-HA (≤1.5 mL/lip) or no treatment. Co-primary effectiveness end points were blinded-evaluator MLFS score for upper or lower lip at week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale [GAIS], safety assessments) were measured throughout the study. RESULTS: Statistically significantly more MLFS responders (≥1 grades of MLFS improvement at week 8) received SGP-HA (93% combined upper and lower lip responders [95% upper lip; 94% lower lip]) than no treatment (29% combined; p < .001). SGP-HA improved self-assessed combined lip GAIS (97% week 8; 74% week 24) significantly more than no treatment (0% throughout; p < .001). The SGP-HA group reported anticipated swelling (58%) and bruising (44%), 88% mild or 11% moderate severity, without unanticipated device adverse events. CONCLUSIONS: SGP-HA is highly effective and well tolerated for lip augmentation. Statistically significant improvement was evident based on the MLFS at 8 weeks, with visible results reported in the majority of participants 6 months after treatment.

An evaluation of neutralizing antibody induction during treatment of glabellar lines with a new US formulation of botulinum neurotoxin type A.

BACKGROUND: The induction of neutralizing antibodies during the aesthetic application of botulinum neurotoxin type A is rare, but of potential clinical concern. Phase III studies of a new US formulation of botulinum neurotoxin type A, Dysport (BoNTA-ABO [abobotulinumtoxinA]; Medicis Aesthetics, Scottsdale, AZ), have not identified any cases of neutralizing antibody formation during the treatment of glabellar lines in patients who received up to nine treatments. OBJECTIVE: To provide an in-depth analysis of the potential for induction of neutralizing antibodies in the study population enrolled in phase III trials of BoNTA-ABO in the treatment of glabellar lines. METHODS: First and last available serum samples from patients in the BoNTA-ABO Glabellar Lines Development Program were screened for BoNTA-ABO antibodies with a radioimmunoprecipitation assay (RIPA), followed by a confirmatory competitive assay (RIPA-C). Confirmed RIPA-C-positive samples were further evaluated for the presence of neutralizing antibodies using a mouse protection assay (MPA), a highly specific bioassay for neutralizing antibodies. We conducted safety and efficacy evaluations, including day 30 responder rate (a rating of no or mild glabellar lines) and duration of response in the last treatment cycle. RESULTS: Of 1554 patients who received at least one BoNTA-ABO treatment (10 units at five injection points, for a total dose of 50 units/treatment; range one to nine treatments), five (0.32%) were antibody positive on the RIPA-C assay-two at baseline and three at the last treatment cycle. None of the RIPA-C-positive samples tested positive for neutralizing antibodies upon further evaluation using the highly specific MPA. Of note, the RIPA-C-positive group had a responder rate of 100% and a mean response of 103.3 days, while the RIPA-C-negative group had a responder rate of 90% and a mean response of 89.4 days. The safety of BoNTA-ABO did not appear to be altered in the RIPA-C-positive group. CONCLUSIONS: At the dose and treatment interval used in the correction of glabellar lines, induction of neutralizing antibodies to BoNTA-ABO was not observed. None of the five samples that initially gave positive results in a RIPA-C assay were positive when further evaluated using the MPA. Clinically, RIPA-C-positive status did not correlate with any reduction in efficacy or an altered safety profile, although the small numbers prevent definitive conclusions. These data suggest that the five RIPA-C-positive samples represented false positives.

Tacrolimus ointment for the treatment of atopic dermatitis: clinical and pharmacologic effects.

The topical immunomodulator tacrolimus ointment has been shown to be safe and effective in the treatment of atopic dermatitis in clinical trials involving over 16,000 patients. Clinical trial results focusing on tacrolimus' safety and efficacy are summarized. Minimal systemic absorption results from topical application in patients with atopic dermatitis. Although the exact mechanism of action of tacrolimus ointment in atopic dermatitis is unknown, tacrolimus is known to inhibit up-regulation of cytokine production following T cell activation and to decrease Fc epsilon RI expression on dendritic antigen-presenting cells in skin. Additional mechanisms of action of tacrolimus relevant in the pathogenesis of inflammatory skin disorders are discussed.