|By PR Newswire||
|April 26, 2014 02:00 PM EDT||
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.
"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.
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.
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
SOURCE American Society for Aesthetic Plastic Surgery
SYS-CON Media announced today that Skytap blog on "DevOps Journal" exceeded 84,000 story reads. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Noel Wurst is the managing content editor at Skytap. Skytap provides SaaS-based dev/test environments to the enterprise. Skytap solution removes the inefficiencies and constraints that comp...
Dec. 22, 2014 08:00 PM EST Reads: 591
SYS-CON Media announced today that Sematext launched a popular blog feed on DevOps Journal with over 6,000 story reads over the weekend. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done. Sematext is a globally distributed organization that builds innovative Cloud and On Premises solutions for performance monitoring, alerting an...
Dec. 22, 2014 08:00 PM EST Reads: 1,131
ScriptRock makes GuardRail, a DevOps-ready platform for configuration monitoring. Realizing we were spending way too much time digging up, cataloguing, and tracking machine configurations, we began writing our own scripts and tools to handle what is normally an enormous chore. Then we took the concept a step further, giving it a beautiful interface and making it simple enough for our bosses to understand. We named it GuardRail after its function - to allow businesses to move fast and stay sa...
Dec. 22, 2014 06:30 PM EST Reads: 1,159
SYS-CON Events announced today Isomorphic Software, the global leader in high-end, web-based business applications, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Isomorphic Software is the global leader in high-end, web-based business applications. We develop, market, and support the SmartClient & Smart GWT HTML5/Ajax platform, combining the productivity and performance of traditional desktop software ...
Dec. 22, 2014 06:00 PM EST Reads: 1,423
SYS-CON Events announced today that Cloudian, Inc., the leading provider of hybrid cloud storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cloudian, Inc., is a Foster City, California - based software company specializing in cloud storage software. The main product is Cloudian, an Amazon S3-compliant cloud object storage platform, the bedrock of cloud computing systems, that enables c...
Dec. 22, 2014 04:00 PM EST Reads: 801
Leysin American School is an exclusive, private boarding school located in Leysin, Switzerland. Leysin selected an OpenStack-powered, private cloud as a service to manage multiple applications and provide development environments for students across the institution. Seeking to meet rigid data sovereignty and data integrity requirements while offering flexible, on-demand cloud resources to users, Leysin identified OpenStack as the clear choice to round out the school's cloud strategy. Additional...
Dec. 22, 2014 11:15 AM EST Reads: 2,020
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, p...
Dec. 22, 2014 11:00 AM EST Reads: 2,364
The BPM world is going through some evolution or changes where traditional business process management solutions really have nowhere to go in terms of development of the road map. In this demo at 15th Cloud Expo, Kyle Hansen, Director of Professional Services at AgilePoint, shows AgilePoint’s unique approach to dealing with this market circumstance by developing a rapid application composition or development framework.
Dec. 22, 2014 11:00 AM EST Reads: 1,474
In high-production environments where release cycles are measured in hours or minutes — not days or weeks — there's little room for mistakes and no room for confusion. Everyone has to understand what's happening, in real time, and have the means to do whatever is necessary to keep applications up and running optimally. DevOps is a high-stakes world, but done well, it delivers the agility and performance to significantly impact business competitiveness.
Dec. 21, 2014 07:00 PM EST Reads: 1,084
"Our premise is Docker is not enough. That's not a bad thing - we actually love Docker. At ActiveState all our products are based on open source technology and Docker is an up-and-coming piece of open source technology," explained Bart Copeland, President & CEO of ActiveState Software, in this SYS-CON.tv interview at DevOps Summit at Cloud Expo®, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 21, 2014 06:00 PM EST Reads: 2,070
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover ...
Dec. 21, 2014 02:00 PM EST Reads: 2,450
"BSQUARE is in the business of selling software solutions for smart connected devices. It's obvious that IoT has moved from being a technology to being a fundamental part of business, and in the last 18 months people have said let's figure out how to do it and let's put some focus on it, " explained Dave Wagstaff, VP & Chief Architect, at BSQUARE Corporation, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 21, 2014 01:00 PM EST Reads: 2,043
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com...
Dec. 21, 2014 11:30 AM EST Reads: 2,452
Verizon Enterprise Solutions is simplifying the cloud-purchasing experience for its clients, with the launch of Verizon Cloud Marketplace, a key foundational component of the company's robust ecosystem of enterprise-class technologies. The online storefront will initially feature pre-built cloud-based services from AppDynamics, Hitachi Data Systems, Juniper Networks, PfSense and Tervela. Available globally to enterprises using Verizon Cloud, Verizon Cloud Marketplace provides a one-stop shop fo...
Dec. 21, 2014 11:00 AM EST Reads: 2,026
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada...
Dec. 21, 2014 10:00 AM EST Reads: 2,203