Submental Fat Research Articles

Proper Technique for Administration of ATX-101 (Deoxycholic Acid Injection): Insights From an Injection Practicum and Roundtable Discussion.

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]) is the first aesthetic injectable approved for reduction of submental fat. In February 2014, an injection practicum was conducted in the anatomy laboratory at the University of Texas Southwestern Medical Center to explore the proper injection technique for ATX-101 and the importance of its appropriate, safe anatomical placement within the submental area. Subsequent to the injection practicum, a structured roundtable discussion was conducted in which potential implications of the various injection protocols evaluated during the practicum were reviewed. Furthermore, the faculty had the opportunity to provide additional perspectives based on their clinical experience with facial injectables and ATX-101 specifically. In this article, the findings from the injection practicum and roundtable discussion are reported.

Deoxycholic Acid: A Review in Submental Fat Contouring.

Deoxycholic acid is a secondary bile acid involved in dietary fat emulsification/solubilization that causes adipocyte lysis when injected into subcutaneous fat tissue. A 10mg/mL injectable solution of synthetic deoxycholic acid (Kybella™; Belkyra™) is indicated in various countries, including the USA and several within Europe/the EU, to improve the appearance of moderate to severe convexity or fullness associated with submental fat (SMF) in adults, where it is currently the only approved treatment for fat below the chin. In several phase III trials conducted in this setting, injecting deoxycholic acid 2mg/cm2 into the SMF reduced the convexity/fullness of moderate to severe SMF relative to placebo (with a single treatment comprising up to 50 injections, and up to six treatments given at least 1month apart). These SMF benefits (which were measured subjectively by clinicians and recipients, as well as objectively, 12weeks after the last treatment session) generally occurred without detriment to skin laxity and were largely maintained over extended follow-up (e.g. 2years after treatment). Deoxycholic acid injections are generally well tolerated, with adverse events usually involving the treatment area, being mild to moderate in severity and resolving within approximately one treatment interval. However, not all patients with SMF may be suitable for deoxycholic acid therapy, making patient selection key to achieving desired aesthetic outcomes. Thus, deoxycholic acid injections are an effective and generally well tolerated, minimally invasive option for the treatment of moderate to severe SMF in select adults.

A Review on the Safety and Efficacy of ATX-101 in the Reduction of Submental Fat

Submental fullness, if associated with subcutaneous fat, can detract from an otherwise balanced and harmonious facial appearance - leading to an older and heavier look. According to a 2014 survey by the American Society for Dermatologic Surgery, approximately 7 out of 10 consumers are bothered by submental fullness. Traditional options for submental fullness include cervical rhytidectomy, liposuction and nonsurgical treatment strategies for SMF reduction such as mesotherapy; however, these methods are not without side effects and complications. ATX-101 is a first-in-class, injectable drug that has been developed for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat (SMF). Treatment with ATX-101 represents a nonsurgical, in-office procedure for reduction of SMF with no general anesthesia, and is a less invasive alternative to liposuction with or without neck lift. Across all studies, the efficacy results consistently demonstrate the superiority of ATX-101 relative to placebo in the reduction of SMF. The safety and tolerability of ATX-101 have been well characterized across a comprehensive development program and are acceptable. Therefore, given the overall balance of risks and benefits described, ATX-101 represents a safe, effective, and less invasive alternative to current treatment options for improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.

Addressing the “Double Chin:” Trends in Submental Contouring

The dreaded ldquo double chin rdquo is a result of excess submental fat This appearance is often psychologically dissatisfying to patients and as such they seek consultation to adjust their submental profile to a more aesthetically pleasing one A recent survey of patients demonstrated that of patients presenting to their dermatologist or plastic surgeon were concerned about submental fat and of patients wanted it reduced Bothsurgical and non invasive options are available however finding the right approach is of the utmost importance to yield the best possible outcome Often times multiple modalities are used to address the various components of the aging face Injectable fillers liposuction laser lipolysis and a host of other methodologies can be combined to rejuvenate the face

A template for estimating doses of deoxycholic acid for submental fat fullness

See related article on page 788

Deoxycholic Acid Injection for the Reduction of Submental Fat in Adults

Deoxycholic Acid Injection for the Reduction of Submental Fat in Adults

ATX-101 (deoxycholic acid injection) for reduction of submental fat

ABSTRACTIntroduction: The shape and contour of the chin and neck play an important role in facial esthetics. As such, excess fat within the submental area (double chin) can negatively affect facial esthetics and body image. Common treatments for submental contouring include invasive procedures such as surgical rejuvenation and targeted liposuction. Energy devices (lasers, radiofrequency, and ultrasound) may be used to improve submental skin laxity while cryolipolysis was recently cleared in the United States for use in the submental area. However, ATX-101 (deoxycholic acid injection) is the only injectable drug approved in the United States and Canada for reduction of submental fat.Areas covered: The efficacy and safety of ATX-101 have been extensively evaluated in a global clinical development program including multiple Phase I/II studies and four large Phase III trials. Available data from ATX-101 trials are reviewed.Expert commentary: Injectables have been well established for facial rejuvenation. Extending injectable treatment into the chin and neck is a major advance for nonsurgical cosmetic correction. Overall, the evidence supports ATX-101 as a safe and effective, minimally invasive treatment alternative for reduction of submental fat that will provide a major tool for the esthetic physician.

Deoxycholic Acid (ATX-101) for Reduction of Submental Fat.

To review trials evaluating purified synthetic deoxycholic acid (DCA; ATX-101) for the reduction of submental fat (SMF). A literature search was conducted using MEDLINE (1946 to week 4 of April 2016) and Evidence Based Medicine Database (1974 to 6 May, 2016). Keywords searched included deoxycholic acid, ATX-101, and submental fat. All human studies published in English that addressed the effects of DCA for the reduction of SMF were selected for analysis. Five phase III, multicenter, randomized, double-blinded clinical trials enrolling more than 1700 patients have demonstrated the efficacy of ATX-101 in the reduction of SMF via a variety of validated scales as well as objective measurements. Purified synthetic DCA 2 mg/cm(2) injected monthly for 4 to 6 treatment sessions demonstrated improvement in scales evaluated by both clinicians and patients. Improvement in skin caliper measurements of SMF and Magnetic Resonance Imaging (MRI) provide objective evidence of the efficacy of ATX-101. Adverse events (AEs) are very common but are transient and localized to the treatment area. Pain at the injection site is the most common AE, occurring in more than 80% of patients treated. Other common AEs include swelling, bruising, numbness, and induration. Appropriate injection technique is patient specific and requires detailed knowledge of the submental anatomy to minimize AEs. ATX-101 is the first pharmacological intervention approved for the reduction of SMF and offers an alternative to invasive measures to improve the submental profile and positively affect patient self-image.

ATX-101 for reduction of submental fat: A phase III randomized controlled trial

ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat. We sought to evaluate the efficacy and safety of ATX-101. In this phase III trial (REFINE-2), adultsdissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging-based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes. Among those treated with ATX-101 or placebo (n=258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P<.001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P<.001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site. Follow-up was limited to 44weeks. ATX-101 is an alternative treatment for SMF reduction.

Neck Rejuvenation Using a Combination Approach: Our Experience and a Review of the Literature.

Aging of the neck is characterized by changes that include skin dyspigmentation, laxity, rhytides, loss of the mandibular contour, widening of the cervicomental angle, accumulation of submental fat, volume loss and prominence of the platysmal bands. Many cosmetic options exist to address these changes individually, but little literature exists about the safety and efficacy of combining such procedures and devices. To review the existing literature and the authors' experience in safely and effectively combining aesthetic rejuvenation modalities for the neck. A Medline search was performed on combination treatments for neck rejuvenation, and results are summarized. Practical applications for combining these procedures are discussed. Studies examining the efficacy and safety of intense pulsed light, ablative fractional lasers, nonablative fractional lasers, microfocused ultrasound with visualization, thermistor-controlled subsurface monopolar radiofrequency, cryolipolysis, ATX-101, liposuction, laser lipolysis, neuromodulators, and hyaluronic acid dermal fillers in the neck were found. The authors review their experience in combining these techniques. Review of the literature revealed options for non- and minimally-invasive rejuvenation of the skin and volume restoration of the neck, but little literature was found on the safety and efficacy of combining such procedures. The authors' experience in clinical practice is that many neck rejuvenation techniques can be combined safely. A combination approach often produces the most optimal outcome for the patient seeking neck rejuvenation.

Clinical efficacy of facial masses caused by exogenous growth factor injections

Objective To explore the reasons and the best treatment options of facial mass complicated after exogenous growth factor injections. Methods 17 cases of postoperative complications caused by exogenous growth factor injections were retrospectively analyzed. 15 patients with chin masses received mass resection and repairment with submental fat and fascial flap. Facial masses of the other 2 patients were located in cheek. Simple cheek mass resection was usually useful. All the patients had scar treatment. The postoperative satisfactory survey was investigated after 6 months. Results The incisions of 17 patients were healed well. An analysis through color Doppler ultrasound examination showed no residual or recurrent mass within half a year follow-up. One of the 17 patients had facial asymmetry and needed further treatment. Others were satisfied with the facial appearance of treatment. Conclusions The masses resulted from injection of exogenous growth factor should be cut off timely and reasonable reconstruction through fat and fascial flap and scar treatment are helpful to restore the original appearance of patients. Key words: Growth factor; Face; Mass; Complications

L’utilisation de l’acide désoxycholique (ATX-101) en médecine esthétique : un traitement prometteur

ATX-101 is a synthetic derivative from deoxycholic acid, which leads to destruction of adipocytes and to a skin retraction. The US Food and Drug Administration (FDA) has authorized ATX-101 injections for reduction of moderate to severe submental fat. The purpose of this note is to review the data of literature regarding the deoxycholic acid (ATX-101) where a significant difference for the submental fat between the treated group and the placebo group according to clinical and morphological criteria was observed (Refine Study 1 and 2). Side effects of this molecule seems to be limited.

PMH38 - Development and Validation of A Patient-Reported Outcome Measure of the Psychological Impact of Submental Fat

PMH38 - Development and Validation of A Patient-Reported Outcome Measure of the Psychological Impact of Submental Fat

Additional thoughts on the new treatment Kybella.

With the recent approval of Kythera Biopharmaceuticals (Westlake Village, California) submental fat injectable treatment Kybella, there comes a lot of excitement-but, also a bit of concern. The idea of having a nonsurgical, nonliposuction treatment for people who have a double chin is certainly exciting. The hope has been that this new treatment will provide opportunities for the many people out there who are focused on the appearance of their submental fullness to have access to a safe. affordable, and reliable treatment.With the approval of this product. there are several misconceptions that the authors herein discuss.

Treatment of Submental Fat Deposit with Cholanic Acid Intra-Adipocyte Lipolysis Compared with Liposuction Prospective Study

Introduction: Over the years, liposuction has been the standard treatment for localized fatty deposit. Lipolysis is a controversial procedure based generally on phosphatidylcholine and deoxycholate injection. The purpose of this study was to compare the efficacy of cholanic acid Aqualyx with the efficacy of liposuction in women with moderate submental fatty collection. Materials and Methods: A prospective randomized study of 30 women with moderate submental fatty collection. Half of the subjects were treated with cholanic acid Aqualyx and the other half with liposuction. Responses were assessed clinically and statistically. Results: Although the lipolysis group showed a better response, it is difficult to conclude that adipocytolisis leads to greater fat reduction compared with liposuction.

Efficacy of ATX-101 for reducing submental fullness associated with submental fat in demographic subgroups of subjects from the US/CAN phase 3 trials, REFINE-1 and REFINE-2

Efficacy of ATX-101 for reducing submental fullness associated with submental fat in demographic subgroups of subjects from the US/CAN phase 3 trials, REFINE-1 and REFINE-2

Clinically meaningful reduction in submental fat during and after treatment with ATX-101 in the US/CAN phase 3 trials, REFINE-1 and REFINE-2

Clinically meaningful reduction in submental fat during and after treatment with ATX-101 in the US/CAN phase 3 trials, REFINE-1 and REFINE-2

Laserlipolysis in the cervical region

Laserlipolysis has been proven a safe and effective procedure for the treatment of the aging of the cervical region. The technique involves the use of laser energy to induce lipolysis and encouraging neocollagenesis, removing submental fat and acting on local skin sagging. The present article offers a brief review of laserlipolysis in the treatment of the cervical region and reports the authors’ experience in the use of the technique

A Pooled Analysis of the Safety and Efficacy Results of the Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase 3 REFINE-1 and REFINE-2 Trials of ATX-101, a Submental Contouring Injectable Drug for the Reduction of Submental Fat

A Pooled Analysis of the Safety and Efficacy Results of the Multicenter, Double-Blind, Randomized, Placebo-Controlled Phase 3 REFINE-1 and REFINE-2 Trials of ATX-101, a Submental Contouring Injectable Drug for the Reduction of Submental Fat

Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat.

BackgroundThe injectable adipocytolytic drug ATX-101 is the first nonsurgical treatment for the reduction of submental fat (SMF) to undergo comprehensive clinical evaluation. This study aimed to confirm the efficacy and safety of ATX-101 for SMF reduction through a post hoc pooled analysis of two large phase 3 studies.MethodsPatients with unwanted SMF were randomized to receive 1 or 2 mg/cm2 of ATX-101 or a placebo injected into their SMF during a maximum of four treatment sessions spaced approximately 28 days apart, with a 12-week follow-up period. The proportions of patients with reductions in SMF of one point or more on the Clinician-Reported SMF Rating Scale (CR-SMFRS) and the proportions of patients satisfied with the appearance of their face and chin [Subject Self-Rating Scale (SSRS) score ≥4] were reported overall and in subgroups. Other efficacy measures included improvements in the Patient-Reported SMF Rating Scale (PR-SMFRS), calliper measurements of SMF thickness, and assessment of skin laxity [Skin Laxity Rating Scale (SLRS)]. Adverse events and laboratory test results were recorded.ResultsSignificantly greater proportions of the patients had improvements in clinician-reported measures (≥1-point improvement in CR-SMFRS: 58.8 and 63.8 % of the patients who received ATX-101 1 and 2 mg/cm2, respectively, and 28.6 % of the placebo recipients; p < 0.001 for both ATX-101 doses vs. placebo) and patient-reported measures (≥1-point improvement in PR-SMFRS: 60.0 and 63.1 % of the patients who received ATX-101 1 and 2 mg/cm2, respectively, vs. 34.3 % of the placebo recipients; p < 0.001 for both), analyzed alone or in combination, with ATX-101 versus placebo. These improvements correlated moderately with patient satisfaction regarding face and chin appearance (SSRS score ≥4: 60.8 and 65.4 % of the patients who received ATX-101 1 and 2 mg/cm2, respectively, vs. 29.0 % of the placebo recipients; p < 0.001 for both). In this study, ATX-101 was effective irrespective of gender, age, or body mass index. Reduction in SMF with ATX-101 was confirmed by calliper measurements (p < 0.001 for both doses vs. placebo) and generally did not lead to worsening of skin laxity (SLRS improved or was unchanged: 91.3 and 90.5 % of the patients who received ATX-101 1 and 2 mg/cm2, respectively, and 91.6 % of the placebo recipients). Adverse events were mostly transient, mild to moderate in intensity, and localized to the treatment area.ConclusionThe findings show ATX-101 to be an effective and well-tolerated pharmacologic treatment for SMF reduction.Level of Evidence IThis journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.