Navigation Links
Investigational New Drug Application for 'Fat Melting' Injections Cleared by the FDA
Date:9/4/2007

Clinical trial on injection lipolysis treatment to begin soon

NEW YORK, Sept. 4 /PRNewswire-USNewswire/ -- The Aesthetic Surgery Education and Research Foundation (ASERF) announced today that it has received approval from the U.S. Food and Drug Administration to initiate a clinical trial investigating the safety and efficacy of one type of injection lipolysis treatment.

Treatments most properly called injection lipolysis have been commonly associated with the terms mesotherapy or fat dissolving "Lipodissolve." These types of treatments claim to reduce or eliminate unwanted local accumulations of fat, but their ingredients and injection locations and techniques may vary slightly. There is also no standardized, consistent, and accepted injection protocol or chemical formulation, with many formulas being proprietary, and without scientifically valid studies documenting their safety or effectiveness or comparing one another. Injection lipolysis involves the injection of various compounds into the subcutaneous fat, but is not currently approved by the FDA for subcutaneous injection for any purpose.

"We are pleased to finally have the approval to move forward on this important clinical trial," said V. Leroy Young, MD, chief investigator for the study. "This study is long overdue, and will go a long way toward developing more standardized protocols and ultimately improving patient safety in this area."

The study, which was designed and funded by ASERF, will be conducted under FDA supervision and will follow patients for 46 weeks to evaluate the efficacy of one form of injection lipolysis and collect data on local and systemic reactions and any long-term complications. The study will include imaging, biochemical analysis and clinical measurements for objective evaluation of the efficacy and safety of the treatment.

"Although there are clinical reports of significant and positive results, they are all anecdotal, and unfortunately there is currently insufficient scientifically valid evidence to support the long term safety and efficacy of injection lipolysis. We hope that this study will provide the data needed to clarify some of the controversy and confusion surrounding this potentially beneficial treatment. The more we know, the better we will be able to educate and inform our patients, and recommend to them, with confidence, the safest and most effective treatments to provide them with the best results," said Alan H. Gold, MD, president of ASERF.

According to the American Society for Aesthetic Plastic Surgery's 2006 Cosmetic Surgery Statistics, injection lipolysis procedures were performed last year on 28,901 Americans -- six times the number of procedures performed the previous year.

About ASERF

The Aesthetic Surgery Education and Research Foundation (ASERF) is dedicated to directed research and physician education in cosmetic plastic surgery. ASERF helps to ensure the safety and effectiveness of new aesthetic (cosmetic) plastic surgical techniques and technologies by funding scientific research and clinical studies, and helps to make new treatments with proven benefits more widely available to patients who seek to improve their quality of life through aesthetic surgery. ASERF is a charitable organization, the research arm of the Society, 100% of member donations go to clinical research. http://www.aserf.org

About ASAPS

The American Society for Aesthetic Plastic Surgery, the leading organization of board-certified plastic surgeons specializing in cosmetic plastic surgery. ASAPS active-member plastic surgeons are certified by the American Board of Plastic Surgery or the Royal College of Physicians and Surgeons of Canada. http://www.surgery.org


'/>"/>
SOURCE Aesthetic Surgery Education and Research Foundation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. New Drug Application Submitted for Investigational Antibiotic Doripenem
2. Astrazenecas Investigational Cancer Therapies Revealed at ASCO
3. Investigational Drug Being Pursued for the Treatment of Ischaemic Stroke
4. Novel Investigational Drug May Help American Women Suffering from Breast Pain
5. Novartis files application with FDA for Zometa
6. Morepan to file new drug applications with the USFDA
7. Mini motor for micromedical applications
8. Perfusion bioreactor could enhance stem cell research and application in the future
9. Prostate Cancer Can Be Treated By Application Of LASER Technology
10. Varied Applications of Adult Stem Cells to Treat Host of Disorders in Human
11. Venus Remedies Files 5th International Patent Application
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... ... 2016 , ... First Choice Emergency Room , the largest network of ... Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased to ... said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/24/2016)... Los Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... plastic surgery procedures that most people are unfamiliar with. The article goes on to ... known procedures, but also many of these less common operations such as calf and ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, FL. ... articles published in Emergency Medicine Practice and Pediatric Emergency Medicine Practice. ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research and ... Global Market - Forecast to 2022" report to their ... treatment method for the patients with kidney failure, it replaces ... fluid from the patient,s blood and thus the treatment helps ... and chloride in balance. Increasing number of ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
(Date:6/23/2016)... -- Bracket , a leading clinical trial technology and ... platform, Bracket eCOA (SM) 6.0, at the 52 nd ... 2016 in Philadelphia , Pennsylvania.  A demonstration ... of its kind to fully integrate with RTSM, will be ... is a flexible platform for electronic clinical outcomes assessments that ...
Breaking Medicine Technology: