Click here to close now.

Welcome!

News Feed Item

Injectable Drug Offers Promises As A Nonsurgical Alternative To Reducing Fat Under The Chin

Clinical Trials Point Toward 'ATX-101' as Potential Noninvasive Solution for Reduction of Submental Fat

SAN FRANCISCO, April 26, 2014 /PRNewswire-USNewswire/ -- Skin laxity and fat buildup under the chin is a common concern among facial aesthetic patients. Although surgery has long been the mainstay for reducing fat in this area, which is also known as the submental region, new research being presented at the Annual Meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) being held April 24-29, 2014 in San Francisco, CA, shows the potential of a novel injectable drug for submental fat reduction. Steven H. Dayan, MD who practices in Chicago, IL, will present the latest data from clinical trials of a new, investigational injectable drug, ATX-101, during "ATX-101, A Submental Contouring Injectable Drug for the Reduction of Submental Fat" on Saturday, April 26th.  

The American Society For Aesthetic Plastic Surgery, Inc

"An unfavorable profile can make people look older and heavier, negatively affect self-esteem, and cannot usually be significantly altered by diet or exercise," said Dr. Dayan. "We are excited to present trial results on this potential first-in-class submental contouring injectable, which, if approved, could offer physicians and their patients a non-surgical option to eliminate fat under the chin, resulting in a thinner and more contoured profile and jawline."

Dr. Dayan is presenting the first disclosure of a pooled analysis of two positive ATX-101 Phase III trials (REFINE-1 and REFINE-2) evaluating the reduction of submental fat. Results of the pooled analysis, conducted by KYTHERA Biopharmaceuticals, found that:

  • 68.2 percent of ATX-101 (2 mg/cm2) subjects demonstrated a simultaneous improvement of at least one grade from baseline on clinician and patient reported rating scales vs. 20.5 percent in placebo (p<0.001).
  • After two treatments, 52.2 percent of subjects achieved at least a one grade change from baseline in the clinician submental fat ratings, and 71.5 percent after four treatments.
  • Response to ATX-101 was consistent across demographic and baseline subgroups with approximately 80 percent of subjects treated with ATX-101 demonstrating at least a one grade improvement in the clinician submental fat ratings regardless of age, gender, race, BMI, Fitzpatrick Skin Type and baseline severity.
  • Those treated with ATX-101 reported significant improvement in the visual and emotional impact of chin fat, including appearing thinner and more youthful, compared with those treated with placebo (p<0.001).

"Eliminating fat in the  submental region not only plays a critical role in helping restore overall facial balance and harmony, but can also lead to vast improvements in self-perception as well as the first impression projected," said Dr. Dayan. "We are looking forward to sharing our findings, which show how a noninvasive injection might offer patients the treatment option they've been desiring."

The pooled analysis also found that 80.9 percent of ATX-101 treatment-emergent adverse events were mild and 1.4 percent of ATX-101 subjects discontinued the studies due to adverse events. The most common adverse events observed in the clinical trials included temporary injection site events of pain, swelling, bruising and numbness. The incidence and severity of pain and swelling declined after the first treatment session.

ATX-101 is a proprietary formulation of a purified synthetic version of a naturally occurring molecule (deoxycholic acid) that aids in the breakdown of dietary fat. It is currently in late stage clinical trials for the reduction of submental fat, which commonly presents as a double chin. When injected into subcutaneous fat, ATX-101 contours the area under the chin by destroying fat cells while leaving surrounding tissue largely unaffected. It has been evaluated in double-blind, randomized, placebo-controlled clinical trials being conducted in the US and Canada with over 2,500 participants who have moderate-to-severe submental fat. Detailed data from a pooled analysis will be revealed during Saturday's presentation.

Title: ATX-101, A Submental Contouring Injectable Drug for the Reduction of Submental Fat: A Pooled Analysis of Two Pivotal Phase 3 (REFINE-1 and REFINE-2) Multicenter, Double-Blind, Randomized, Placebo-Controlled Trials

Date: Saturday, April 26th, 4:38 p.m.5:00 p.m.

Presenting Author: Steven H. Dayan, MD

Additional Authors: Derek H. Jones, MD, Jean Carruthers, MD, FRCS(c), Shannon Humphrey, MD, Fredric S. Brandt, MD, Patricia Walker, MD, Ph.D., Daniel Lee, MS, Paul F. Lizzul, MD, Ph.D., Frederick C. Beddingfield III, MD, Ph.D.

CONTACT THE ASAPS COMMUNICATIONS STAFF TO SCHEDULE INTERVIEWS.

About ASAPS
The American Society for Aesthetic Plastic Surgery (ASAPS) is recognized as the world's leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; Active Members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International Active Members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.

Website: www.surgery.org
Follow ASAPS on Twitter: www.twitter.com/ASAPS
Become a fan of ASAPS on Facebook: www.facebook.com/AestheticSociety
Locate a plastic surgeon in your area: http://www.smartbeautyguide.com/select-surgeon 

Logo - http://photos.prnewswire.com/prnh/20140226/DC72077LOGO

SOURCE American Society for Aesthetic Plastic Surgery

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The cloud has transformed how we think about software quality. Instead of preventing failures, we must focus on automatic recovery from failure. In other words, resilience trumps traditional quality measures. Continuous delivery models further squeeze traditional notions of quality. Remember the venerable project management Iron Triangle? Among time, scope, and cost, you can only fix two or quality will suffer. Only in today's DevOps world, continuous testing, integration, and deployment upend...
The time is ripe for high speed resilient software defined storage solutions with unlimited scalability. ISS has been working with the leading open source projects and developed a commercial high performance solution that is able to grow forever without performance limitations. In his session at Cloud Expo, Alex Gorbachev, President of Intelligent Systems Services Inc., shared foundation principles of Ceph architecture, as well as the design to deliver this storage to traditional SAN storage co...
Discussions about cloud computing are evolving into discussions about enterprise IT in general. As enterprises increasingly migrate toward their own unique clouds, new issues such as the use of containers and microservices emerge to keep things interesting. In this Power Panel at 16th Cloud Expo, moderated by Conference Chair Roger Strukhoff, panelists addressed the state of cloud computing today, and what enterprise IT professionals need to know about how the latest topics and trends affect t...
"We provide a web application framework for building really sophisticated web applications that run on a browser without any installation need so we get used for biotech, defense, and banking applications," noted Charles Kendrick, CTO and Chief Architect at Isomorphic Software, in this SYS-CON.tv interview at @DevOpsSummit (http://DevOpsSummit.SYS-CON.com), held June 9-11, 2015, at the Javits Center in New York
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world...
One of the hottest areas in cloud right now is DRaaS and related offerings. In his session at 16th Cloud Expo, Dale Levesque, Disaster Recovery Product Manager with Windstream's Cloud and Data Center Marketing team, will discuss the benefits of the cloud model, which far outweigh the traditional approach, and how enterprises need to ensure that their needs are properly being met.
"AgilData is the next generation of dbShards. It just adds a whole bunch more functionality to improve the developer experience," noted Dan Lynn, CEO of AgilData, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
Containers are changing the security landscape for software development and deployment. As with any security solutions, security approaches that work for developers, operations personnel and security professionals is a requirement. In his session at DevOps Summit, Kevin Gilpin, CTO and Co-Founder of Conjur, will discuss various security considerations for container-based infrastructure and related DevOps workflows.
To many people, IoT is a buzzword whose value is not understood. Many people think IoT is all about wearables and home automation. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed some incredible game-changing use cases and how they are transforming industries like agriculture, manufacturing, health care, and smart cities. He will discuss cool technologies like smart dust, robotics, smart labels, and much more. Prepare...
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of...
"We have a tagline - "Power in the API Economy." What that means is everything that is built in applications and connected applications is done through APIs," explained Roberto Medrano, Executive Vice President at Akana, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of pro...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
In the midst of the widespread popularity and adoption of cloud computing, it seems like everything is being offered “as a Service” these days: Infrastructure? Check. Platform? You bet. Software? Absolutely. Toaster? It’s only a matter of time. With service providers positioning vastly differing offerings under a generic “cloud” umbrella, it’s all too easy to get confused about what’s actually being offered. In his session at 16th Cloud Expo, Kevin Hazard, Director of Digital Content for SoftL...