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
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists discussed...
Cloud-based disaster recovery is critical to any production environment and is a high priority for many enterprise organizations today. Nearly 40% of organizations have had to execute their BCDR plan due to a service disruption in the past two years. Zerto on IBM Cloud offer VMware and Microsoft customers simple, automated recovery of on-premise VMware and Microsoft workloads to IBM Cloud data centers.
Elon Musk is among the notable industry figures who worries about the power of AI to destroy rather than help society. Mark Zuckerberg, on the other hand, embraces all that is going on. AI is most powerful when deployed across the vast networks being built for Internets of Things in the manufacturing, transportation and logistics, retail, healthcare, government and other sectors. Is AI transforming IoT for the good or the bad? Do we need to worry about its potential destructive power? Or will we...
Many organizations adopt DevOps to reduce cycle times and deliver software faster; some take on DevOps to drive higher quality and better end-user experience; others look to DevOps for a clearer line-of-sight to customers to drive better business impacts. In truth, these three foundations go together. In this power panel at @DevOpsSummit 21st Cloud Expo, moderated by DevOps Conference Co-Chair Andi Mann, industry experts will discuss how leading organizations build application success from all...
SYS-CON Events announced today that SIGMA Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. uLaser flow inspection device from the Japanese top share to Global Standard! Then, make the best use of data to flip to next page. For more information, visit http://www.sigma-k.co.jp/en/.
SYS-CON Events announced today that Daiya Industry will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Daiya Industry specializes in orthotic support systems and assistive devices with pneumatic artificial muscles in order to contribute to an extended healthy life expectancy. For more information, please visit https://www.daiyak...
The last two years has seen discussions about cloud computing evolve from the public / private / hybrid split to the reality that most enterprises will be creating a complex, multi-cloud strategy. Companies are wary of committing all of their resources to a single cloud, and instead are choosing to spread the risk – and the benefits – of cloud computing across multiple providers and internal infrastructures, as they follow their business needs. Will this approach be successful? How large is the ...
Your clients expect transactions to never fail, cloud access to be fast and always on, and their data to be protected - no exceptions. Hear about how Secure Service Container (SSC), an IBM-exclusive open technology, enables secure building and hosting of next-generation applications, both cloud and on-premises. SSC protects the full stack from external and insider threats, allows automatic encryption of data in-flight and at-rest, and is tamper-resistant during installation and runtime – with no...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend 21st Cloud Expo October 31 - November 2, 2017, at the Santa Clara Convention Center, CA, and June 12-14, 2018, at the Javits Center in New York City, NY, and learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that B2Cloud will exhibit at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. B2Cloud specializes in IoT devices for preventive and predictive maintenance in any kind of equipment retrieving data like Energy consumption, working time, temperature, humidity, pressure, etc.
SYS-CON Events announced today that NetApp has been named “Bronze Sponsor” of SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. NetApp is the data authority for hybrid cloud. NetApp provides a full range of hybrid cloud data services that simplify management of applications and data across cloud and on-premises environments to accelerate digital transformation. Together with their partners, NetApp em...
SYS-CON Events announced today that Interface Corporation will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Interface Corporation is a company developing, manufacturing and marketing high quality and wide variety of industrial computers and interface modules such as PCIs and PCI express. For more information, visit http://www.i...
SYS-CON Events announced today that Massive Networks, that helps your business operate seamlessly with fast, reliable, and secure internet and network solutions, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. As a premier telecommunications provider, Massive Networks is headquartered out of Louisville, Colorado. With years of experience under their belt, their team of...
SYS-CON Events announced today that Mobile Create USA will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Mobile Create USA Inc. is an MVNO-based business model that uses portable communication devices and cellular-based infrastructure in the development, sales, operation and mobile communications systems incorporating GPS capabi...
SYS-CON Events announced today that Nihon Micron will exhibit at the Japan External Trade Organization (JETRO) Pavilion at SYS-CON's 21st International Cloud Expo®, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Nihon Micron Co., Ltd. strives for technological innovation to establish high-density, high-precision processing technology for providing printed circuit board and metal mount RFID tags used for communication devices. For more inf...