Shannon Humphrey

Avoiding and Treating Blindness From Fillers: A Review of the World Literature.

BACKGROUND As the popularity of soft tissue fillers increases, so do the reports of adverse events. The most serious complications are vascular in nature and include blindness. OBJECTIVE To review the cases of blindness after filler injection, to highlight key aspects of the vascular anatomy, and to discuss prevention and management strategies. METHODS A literature review was performed to identify all the cases of vision changes from filler in the world literature. RESULTS Ninety-eight cases of vision changes from filler were identified. The sites that were high risk for complications were the glabella (38.8%), nasal region (25.5%), nasolabial fold (13.3%), and forehead (12.2%). Autologous fat (47.9%) was the most common filler type to cause this complication, followed by hyaluronic acid (23.5%). The most common symptoms were immediate vision loss and pain. Most cases of vision loss did not recover. Central nervous system complications were seen in 23.5% of the cases. No treatments were found to be consistently successful in treating blindness. CONCLUSION Although the risk of blindness from fillers is rare, it is critical for injecting physicians to have a firm knowledge of the vascular anatomy and to understand key prevention and management strategies.

Introduction to Fillers.

Background: Over the last few years, injectable soft-tissue fillers have become an integral part of cosmetic therapy, with a wide array of products designed to fill lines and folds and revolumize the face. Methods: This review describes cosmetic fillers currently approved by the Food and Drug Administration and discusses new agents under investigation for use in the United States. Results: Because of product refinements over the last few years—greater ease of use and longevity, the flexibility of multiple formulations within one line of products, and the ability to reverse poor clinical outcomes—practitioners have gravitated toward the use of biodegradable agents that stimulate neocollagenesis for sustained aesthetic improvements lasting up to a year or more with minimal side effects. Permanent implants provide long-lasting results but are associated with greater potential risk of complications and require the skilled hand of the experienced injector. Conclusions: A variety of biodegradable and nonbiodegradable filling agents are available or under investigation in the United States. Choice of product depends on injector preference and the area to be filled. Although permanent agents offer significant clinical benefits, modern biodegradable fillers are durable and often reversible in the event of adverse effects.

Overview of ATX-101 (Deoxycholic Acid Injection): A Nonsurgical Approach for Reduction of Submental Fat.

Abstract In 2015, ATX-101 (deoxycholic acid injection; Kybella in the United States and Belkyra in Canada; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was approved as a first-in-class injectable drug for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat. ATX-101 has been evaluated in a clinical development program that included 18 Phase 1 to 3 studies supporting the current indication. Since 2007, the toxicity and safety profiles of ATX-101 have been characterized in numerous preclinical studies, its pharmacokinetics, pharmacodynamics, and optimal treatment paradigm have been defined in multiple Phase 1 and 2 studies, and its efficacy and clinical safety have been confirmed in 4 large Phase 3 trials (2 conducted in Europe and 2 in the United States and Canada [REFINE-1 and REFINE-2]). As subcutaneous injection of deoxycholic acid has been shown to cause adipocytolysis, the reduction in submental fat achieved after ATX-101 treatment is expected to be long lasting. This prediction is confirmed by data from long-term follow-up studies of up to 4 years after last treatment with ATX-101, which demonstrate that the treatment response is maintained over time in most subjects. ATX-101 offers a durable, minimally invasive alternative to liposuction and surgery for addressing submental fullness.

Canadian Clinical Practice Guidelines for Rosacea

Rosacea is a chronic facial inflammatory dermatosis characterized by background facial erythema and flushing and may be accompanied by inflammatory papules and pustules, cutaneous fibrosis and hyperplasia known as phyma, and ocular involvement. These features can have adverse impact on quality of life, and ocular involvement can lead to visual dysfunction. The past decade has witnessed increased research into pathogenic pathways involved in rosacea and the introduction of novel treatment innovations. The objective of these guidelines is to offer evidence-based recommendations to assist Canadian health care providers in the diagnosis and management of rosacea. These guidelines were developed by an expert panel of Canadian dermatologists taking into consideration the balance of desirable and undesirable outcomes, the quality of supporting evidence, the values and preferences of patients, and the costs of treatment. The 2015 Cochrane review “Interventions in Rosacea” was used as a source of clinical trial evidence on which to base the recommendations.

Cryolipolysis and skin tightening.

BACKGROUND Anecdotally, there have been reports of skin tightening after cryolipolysis, but this has not been studied or reported in the literature. OBJECTIVE This clinical evaluation of patients treated with cryolipolysis in the thighs, abdomen, arms, and back assesses changes to skin texture, laxity, and cellulite at 2 study centers. METHODS From the Vancouver site, a comprehensive review of cryolipolysis treatments was performed to assess treatment areas and retreatments. While reviewing data, investigators were struck by the noticeable skin tightening shown in clinical photographs. Subsequently, a survey of Vancouver patients was conducted to assess changes to skin texture and laxity. At the Marina del Rey site, subjects undergoing a clinical study for lateral thigh cryolipolysis were evaluated for changes to skin texture, laxity, and cellulite. RESULTS Independent assessments by patients and investigators found consistent improvement in skin texture and laxity for treatments to the outer thighs, abdomen, arms, and back. Outer thighs also showed mild-to-moderate improvement in cellulite. CONCLUSION This clinical evaluation demonstrates consistent improvement in skin texture, laxity, and cellulite after cryolipolysis as independently assessed by patients and investigators. Prospective clinical studies should be conducted to objectively study and quantify skin tightening after cryolipolysis.

HIV-associated facial lipoatrophy treated with injectable silicone oil: A pilot study

BACKGROUND Facial lipoatrophy (FLA) is associated with HIV infection and is part of the lipodystrophy syndrome. Temporary filler treatments do not meet the need of the patient, as there is a lack of permanence, and excessive cost. OBJECTIVE We sought to evaluate the safety and efficacy of a highly purified medical-grade 1000-cst liquid injectable silicone in the treatment of HIV-associated FLA using the serial microdroplet injection technique. METHODS Twenty patients with HIV-associated lipoatrophy were treated with liquid injectable silicone with a maximum of 6 treatment sessions (2.0 mL each session maximum). Patients were evaluated at 9-, 12-, and 18-month follow-up sessions. Safety, efficacy, injection volumes, and patient satisfaction were evaluated. RESULTS No persistent adverse effects were reported throughout the study. Most of the patients achieved complete correction of their HIV-associated FLA after 6 treatments and maintained this correction to the 18-month follow-up. LIMITATIONS This is a noncomparative, nonblinded study. Study patient population size is small. CONCLUSION Given our small sample size of 20 patients, our results suggest that, if administered correctly, liquid injectable silicone is potentially a safe, effective, and natural-feeling treatment option for HIV-associated FLA. Larger studies may be needed to confirm safety, efficacy, and permanence.

Injecting botulinum toxin at different depths is not effective for the correction of eyebrow asymmetry.

BACKGROUND It is theorized that brow elevation after treatment with botulinum toxin Type A (BoNT-A) results from inactivation of the brow depressors. Expert consensus is that increased injection depth delivers more BoNT-A to these depressors and causes increased elevation. This technique is applied to the correction of brow height asymmetry. OBJECTIVE To compare changes in brow height after deep versus shallow BoNT-A in patients with brow asymmetry. METHODS A prospective split-face analysis was performed on 23 women with eyebrow-height asymmetry. Subjects received 64 units of BoNT-A, divided among 16 injection sites in the glabella, forehead, and lateral canthal area. On the side where increased brow lift was desired, deep injections were performed and shallow injections on the opposite side. Photographs were taken at baseline and Week 4 for comparison measurements. RESULTS All 23 women enrolled completed baseline injections and returned for the 4-week follow-up. There was no significant difference at 4 weeks in the change in brow height between the sides that received deep versus shallow BoNT-A injection. CONCLUSION Because of the diffusion of the BoNT-A between muscle layers, the eyebrow depressor muscles cannot be accurately targeted with deep injection into the muscle belly for correction of eyebrow height discrepancies.

Elastosis perforans serpignosa: treatment with liquid nitrogen cryotherapy and review of the literature.

Background: Elastosis perforans serpiginosa (EPS) is a rare skin disease in which abnormal elastic tissue fibers, other connective tissue elements, and cellular debris are expelled from the papillary dermis via transepithelial elimination. It is characterized by an eruption of small grouped hyperkeratotic papules in a serpiginous arrangement. This condition presents a therapeutic challenge as many treatments have been reported with inconsistent efficacy. Methods: This article reports a case of a 13-year-old male who presented to our outpatient clinic with a 1-year history of facial lesions showing multiple annular keratotic plaques with slight central atrophy. Conclusion: We report a case of EPS treated successfully with liquid nitrogen cryotherapy. Liquid nitrogen cryotherapy is well tolerated, with few side effects, and can be considered in the management of EPS.

Efficacy and Safety of OnabotulinumtoxinA Treatment of Forehead Lines: A Multicenter, Randomized, Dose-Ranging Controlled Trial.

BACKGROUND Various onabotulinumtoxinA doses are effective in treating forehead lines (FHL), with a trend toward lower doses. OBJECTIVE To evaluate efficacy and safety of onabotulinumtoxinA dose-ranging treatment of FHL when the frontalis area and glabellar complex are treated together. MATERIALS AND METHODS Adults with moderate-to-severe FHL received onabotulinumtoxinA 40 U (FHL, 20 U; glabellar lines [GL], 20 U), 30 U (FHL, 10 U; GL, 20 U), or placebo. Response was assessed at weeks 1, 2, day 30, and monthly to day 180. Coprimary efficacy end points were investigator- and subject-assessed Facial Wrinkle Scale scores of none or mild (day 30). Patient-reported outcomes, onset/duration of effect, and adverse events (AEs) were evaluated. RESULTS Responder rates (investigator/subject, respectively) were 40-U group, 91.2%/89.5%; 30-U group, 86.4%/81.4%; placebo, 1.7%/5.1%. OnabotulinumtoxinA resulted in significantly greater responder rates than placebo (p < .001). Adverse events were mild to moderate and similar between groups (most common AEs: nasopharyngitis [4.6%] and headache [4.0%]). CONCLUSION Treatment of FHL with onabotulinumtoxinA 40 and 30 U (in frontalis and glabellar complex muscles) was tolerable, effective, and sustained. Both doses significantly reduced FHL severity; however, the 40-U dose demonstrated a trend toward greater sustained benefit and longer duration of effect versus the 30-U dose, with similar AE rates.

Clinical Experience With 11,460 mL of a 20-mg/mL, Smooth, Highly Cohesive, Viscous Hyaluronic Acid Filler.

BACKGROUND A 3-dimensional approach to facial rejuvenation restores volume lost over time. Hyaluronic acid (HA) filling agents provide long-lasting correction with minimal side effects and a high level of patient satisfaction. The newest HA formulation is a 20-mg/mL smooth cohesive filler (Juvéderm Voluma [HA-V]) that combines both low- and high-molecular-weight HA for more efficient cross-linking and greater lift capabilities. OBJECTIVE To document the clinical experience with HA-V over the course of 68 months. MATERIALS AND METHODS The authors conducted a retrospective chart review of patients who received HA-V for facial augmentation between February 1, 2009, and October 1, 2014. Clinical results were assessed 2 weeks after initial treatment, with touch-ups performed as necessary. Color photographs were taken before and after treatment, and adverse events were documented. RESULTS Over 68 months, the authors treated 2,342 patients with 11,460 mL of HA-V. Aesthetic results lasted upwards of 12 months, and most side effects were transient and mild. Three patients developed signs of vascular compromise that was promptly treated and resolved within 2 months. Twenty-one patients (<0.5%) experienced late-onset, temporary, nontender nodules that were successfully managed with conservative measures. CONCLUSION Easy to use and well tolerated, HA-V is ideally formulated for soft-tissue augmentation in the face, with clinical effects lasting 12 months or longer.