ATX-101 (Deoxycholic Acid Injection) for Reduction of Submental Fat: Results From a 12-Month Open-Label Study

BACKGROUND: ATX-101 (deoxycholic acid) causes adipocytolysis when injected into subcutaneous fat. OBJECTIVE: Evaluate the long-term safety and efficacy of ATX-101 for submental fat (SMF) reduction. METHODS: Adults (N=165) with moderate-to-extreme SMF received ≤6 treatments of open-label ATX-101 (2 mg/cm2) and were evaluated up to 12 months after last treatment. Efficacy end points included improvements in SMF based on clinician or subject assessment, patient-reported outcomes, downtime (via subject questionnaire), and skin laxity. Safety was evaluated throughout the study. RESULTS: Twelve weeks after last treatment, most subjects achieved a ≥1-grade improvement in SMF based on clinician (86.8%) or subject (83.8%) evaluation; at 12 months, 90.4% and 80.7% of these responders, respectively, maintained the response. Overall, 84.9% of subjects were satisfied with the appearance of their face/chin. At 12 months, 82.9% of subjects had unchanged, and 10.1% had improved, skin laxity relative to 12 weeks after last treatment. Adverse events were mild to moderate and mainly involved the treatment area. During the 7 days after the first treatment, 13.3% of subjects missed work and 33.9% missed social/leisure activities. Following subsequent treatments, 2.4%­6.0% of subjects missed work and 10.0%­15.7% missed social/leisure activities. CONCLUSION: The safety and efficacy of ATX-101 were sustained over 12 months. ClinicalTrials.gov identifier, NCT01426373 J Drugs Dermatol. 2019;18(9):870-877.

Hyaluronic acid fillers with cohesive polydensified matrix for soft-tissue augmentation and rejuvenation: a literature review.

BACKGROUND: Cohesive monophasic polydensified fillers show unique viscoelastic properties and variable density of hyaluronic acid, allowing for a homogeneous tissue integration and distribution of the material. OBJECTIVE: The aim of this paper was to review the clinical data regarding the performance, tolerability, and safety of the Belotero(®) fillers for soft-tissue augmentation and rejuvenation. METHODS: A literature search was performed up until May 31, 2015 to identify all relevant articles on Belotero(®) fillers (Basic/Balance, Hydro, Soft, Intense, Volume) and equivalent products (Esthélis(®), Mesolis(®), Fortélis(®), Modélis(®)). RESULTS: This comprehensive review included 26 papers. Findings from three randomized controlled trials showed a greater reduction in nasolabial fold severity with Belotero(®) Basic/Balance than with collagen (at 8, 12, 16, and 24 weeks, n=118) and Restylane(®) (at 4 weeks, n=40), and higher patient satisfaction with Belotero(®) Intense than with Perlane(®) (at 2 weeks, n=20). With Belotero(®) Basic/Balance, an improvement of at least 1 point on the severity scale can be expected in ~80% of patients 1-6 months after injection, with an effect still visible at 8-12 months. Positive findings were also reported with Belotero(®) Volume (no reduction in hyaluronic acid volume at 12 months, as demonstrated by magnetic resonance imaging), Soft (improvement in the esthetic outcomes when used in a sequential approach), and Hydro (improvement in skin appearance in all patients). The most common adverse effects were mild-to-moderate erythema, edema, and hematoma, most of which were temporary. There were no reports of Tyndall effect, nodules, granulomas, or tissue necrosis. CONCLUSION: Clinical evidence indicates sustainable esthetic effects, good safety profile, and long-term tolerability of the Belotero(®) fillers, particularly Belotero(®) Basic/Balance and Intense.

Correcting age-related changes in the face by use of injectable fillers and neurotoxins.

Many patients seeking rejuvenation treatment have readily apparent age-related changes in facial features. Others exhibit more subtle changes that nonetheless can be corrected to achieve a more youthful appearance. In the following article, four specialists in aesthetic dermatology discuss how injectable hyaluronic acid-based fillers and neurotoxins can achieve rejuvenation without surgery.

Novel post-treatment care after ablative and fractional CO2 laser resurfacing.

OBJECTIVE: This study evaluates a topical oxygen emulsion (TOE) to reduce adverse effects after skin rejuvenation with a fully ablative CO2 laser alone and in combination with a fractional ablative CO2 laser. MATERIALS AND METHODS: Patients (n = 100) seeking skin rejuvenation underwent CO2 laser resurfacing. Group A patients (n = 34) received a single deep fractional laser treatment followed by application of Aquaphor immediately after treatment for 24 h and TOE every 6 h for the next 6 days. Group B patients (n = 66) underwent both deep fractional and fully ablative laser resurfacing followed by application of TOE every 6 h for 7 consecutive days. RESULTS: Patients in both groups showed clinical improvement and a 7.1% overall incidence of adverse effects which included milia (5.1% overall) and hyperpigmentation (3.1% overall). For milia, Group A and Group B individual adverse effect rates were 11.8% and 1.5%, respectively; for hyperpigmentation, individual rates were 0.0% and 3.1%, respectively. CONCLUSION: The elimination of petrolatum products in the post-skin care regimen has significantly reduced the incidence of post-procedure complications when compared with the use of TOE, resulting in the lowest incidence of complications in fully ablative or fractional resurfacing published thus far.

Facial Soft-Tissue Fillers: Assessing the State of the Science conference---Proceedings report.

The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report summarizes the deliberations and key points made by the panel and presenters to the panel, and includes a summary of the panel's near-term and longer term recommendations for next steps to help guide future efforts to address the safety, efficacy, and effectiveness of facial soft-tissue fillers. This report represents the panel's assessment of the medical knowledge available on facial soft-tissue fillers at the time of the conference.

Facial Soft-Tissue Fillers conference: Assessing the State of the Science.

The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.

Facial soft-tissue fillers conference: assessing the state of the science.

SUMMARY: : The American Society of Plastic Surgeons and the American Academy of Dermatology, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Society of Plastic Surgeons and the American Academy of Dermatology established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.

Quantifying facial volumizing.

Mark G. Rubin, MD, has indicated no significant interest with commercial supporters.

The efficacy and safety of a new U.S. Botulinum toxin type A in the retreatment of glabellar lines following open-label treatment.

INTRODUCTION: A new U.S. Botulinum toxin type A (BoNT-A) has been shown to be safe and effective when administered once, but there is a paucity of clinical evidence regarding long-term use. OBJECTIVE: To evaluate the long-term efficacy and tolerability of repeated treatment with BoNT-A in the correction of moderate-to-severe glabellar lines. STUDY DESIGN/METHODOLOGY: Multicenter, phase 3, randomized, placebo-controlled, double-blind study comparing the efficacy of BoNT-A (50 units) with placebo upon re-treatment of glabellar lines following two-to-three cycles of open-label BoNT-A treatment in 311 patients. RESULTS: At endpoint, BoNT-A produced a significantly higher proportion of responders versus placebo. The incidence of treatment-emergent adverse effects (TEAEs) was slightly lower during additional treatment cycles; the frequency was comparable between BoNT-A and placebo groups. CONCLUSION: Multiple treatment cycles of BoNT-A were well tolerated in the majority of patients, and there was no tachyphylaxis seen during the study duration of up to 23 months.

Review of the efficacy, durability, and safety data of two nonanimal stabilized hyaluronic acid fillers from a prospective, randomized, comparative, multicenter study.

BACKGROUND: Nonanimal stabilized hyaluronic acid (NASHA)-based fillers are currently the criterion standard for cosmetic soft tissue augmentation. OBJECTIVE: To report the efficacy, durability, and safety data of a large-particle NASHA filler and a small-particle NASHA filler. METHODS & MATERIALS: A blinded, prospective, randomized subject and evaluator study was conducted at 17 sites in the United States with 248 subjects enrolled. One of the two products was injected into both nasolabial folds and, if deemed necessary, the oral commissures of each subject. A 2-week touch-up injection was provided if necessary. Subjects returned for follow-up visits 2, 6, 12, and 24 weeks after receiving their last injection. Assessments were done using a subject diary, blinded investigator's Wrinkle Severity Rating Score (WSRS), and palpability of product. RESULTS: Both products demonstrated similar efficacy, durability, and safety profiles. CONCLUSION: Although both NASHA fillers demonstrated similar efficacy, durability, and safety, the fanning injection technique, and a faster rate of injection played a key role in the increase in incidence of adverse experiences. Furthermore, the safety of each NASHA product was demonstrated at volumes well beyond the volume range listed on the product inserts.

Acne vulgaris, mental health and omega-3 fatty acids: a report of cases.

Acne vulgaris is a common skin condition, one that is associated with significant psychological disability. The psychological impairments in acne include higher rates of depression, anxiety, anger and suicidal thoughts. Despite a paucity of clinical research, patients with skin conditions and/or mental health disorders are frequent consumers of dietary supplements. An overlap may exist between nutrients that potentially have both anti-acne and mood regulating properties; examples include omega-3 fatty acids from fish oil, chromium, zinc and selenium. Here we report on five cases of acne treated with eicosapentaenoic acid and antioxidant nutrients. Self-administration of these nutrients may have improved inflammatory acne lesions and global aspects of well-being; the observations suggest a need for controlled trials.

Injected hyaluronidase reduces restylane-mediated cutaneous augmentation.

OBJECTIVE: To determine the effects of injected hyaluronidase in cutaneous areas previously augmented with Restylane (Q-Med AB, Uppsala, Sweden), a nonanimal, stabilized hyaluronic acid (NASHA) gel. METHODS: A prospective, randomized study was undertaken in 2 parts. First, the effects of hyaluronidase and saline were compared on post-NASHA dermal augmentation. Next, 3 different doses of hyaluronidase were evaluated after NASHA gel dermal augmentation. A blinded evaluator assigned postinjection skin scores. Each patient served as his or her own control. RESULTS: Hyaluronidase dramatically reduced the size of the augmentation created by injected Restylane in all of our subjects. A comparison of average scores of saline-injected sites vs hyaluronidase-injected sites revealed a statistically significant difference. By 4 to 7 days after hyaluronidase injection, skin scores were at 20% of baseline (P<.001). Dose-related response to injected hyaluronidase was also observed, although it was not statistically significant. A number of patients (25%) demonstrated localized, self-limiting hypersensitivity reactions to injected hyaluronidase. CONCLUSIONS: Intradermal hyaluronidase injections can be used to reduce dermal augmentation from previously injected Restylane. A small dose of hyaluronidase equivalent to 5 to 10 U may be injected initially.

Treatment of nasolabial folds with fillers.

According to the author, injectable dermal fillers can be used effectively to treat nasolabial folds. He offers advice on evaluating the depth and classifying the type of nasolabial fold (crease, fold, or hybrid) and then selecting an appropriate filling agent.

Microabrasion: an epidermal abrasion.

Microabrasion, which abrades the epidermis but does not extend into the dermis, is a mild level of injury that is useful in treating dull, rough texture; dyschromias; comedonal acne; keratosis pilaris; distensible acne scars; and fine lines. Results vary with the use of positive or negative pressure, choice of abrasive crystals, and operator technique. (Aesthetic Surg J 2003;23:137-139.).