Press Release
Oct 24, 2013
Dermatologists develop non-surgical treatment to reduce unwanted chin fat
Scientists have developed a pioneering way to remove unsightly chin fat without the need for surgery,according to research released today in the British Journal of Dermatology.
The novel treatment targets aesthetically unappealing fat deposits underneath the chin, otherwise known as submental fat, or more colloquially as a ‘double chin’.
Dermatologists from the UK, France, Germany, Belgium and Spain have investigated a potential new treatment involving the injection of ATX-101 (a specific, synthetically derived formulation of deoxycholic acid) into submental fat. ATX-101 reduces submental fat by irreversibly disrupting fat cell membranes and causing adipocytolysis (destruction of fat cells). Following injection of ATX-101, an inflammatory response is induced, triggering the recruitment of highly specialised cells (macrophages) which remove the cellular debris resulting from destruction of the fat cells over time.
Submental fat deposits under the chin can be treated effectively with neck and face lifts or with liposuction. However, these treatments are not suitable for everyone, and the need for anaesthesia, an operating room and qualified staff substantially increases costs and risks. There are other non-surgical treatments for submental fat, but there is limited clinical evidence to prove their effectiveness.
The study included 363 men and women aged 18 to 65. Only those who presented with moderate to severe submental fat and expressed dissatisfaction with the appearance of their face and chin were eligible to take part. All the patients agreed to undergo clinical evaluations and laboratory tests and to maintain stable body weight, diet and exercise practices during the study.
The primary goals of the trial were to demonstrate at least a one point improvement in submental fat on the 5-point Clinician-Reported Submental Fat Rating Scale and for patients to show satisfaction with their face and chin appearance on the 7-point Subject Self-Rating Scale (SSRS).
On both the clinician and patient scales (above), significantly more ATX-101 recipients met the primary goals of the trial than a group receiving a placebo treatment. The trial used two different dosages of ATX-101 (1 mg cm-2 and 2 mg cm-2) as well as a placebo.
With the higher dosage of ATX-101, 65.3% of patients had a reduction in submental fat of at least one point on the Clinician-Reported Submental Fat Rating Scale compared with 23.0% with the placebo, and 66.1% of patients were happy with their face and chin appearance, versus 28.7% for the placebo.
In addition, calliper measurements showed a significant reduction in submental fat, with no apparent worsening of skin laxity. Following treatment, patients also reported a reduction in the psychological impact they felt due to the appearance of their face and chin. The treatment was found to invoke just a mild inflammatory response and the procedure was well tolerated by patients.
Matt Gass, of the British Association of Dermatologists, said: “This research is a very exciting step towards a safe and non-surgical solution to removing unwanted chin fat. For people experiencing negative psychological effects of this unwanted fat on their appearance, this procedure, if approved, may open up the option of minimally invasive treatment with proven efficacy.”
Professor Berthold Rzany (Berlin, Germany), the lead author, said: “This study demonstrates that subcutaneous injections with ATX-101 yield a clinically meaningful and statistically significant reduction in unwanted submental fat, decrease the psychological impact on patients, and are well tolerated. This study and three additional phase III clinical trials of ATX-101 will provide the first true evidence base for non-surgical submental fat reduction.”
-Ends-
Notes to editors:
If using this study, please ensure you mention that the study was published in the British Journal of Dermatology.
For more information please contact: Matt Gass, Communications Officer, Phone: 0207 391 6084, or Nina Goad, Head of Communications, 0207 391 6094, Email: comms@bad.org.uk, Website: www.bad.org.uk.
Study details: “Reduction of unwanted submental fat with ATX-101, an adipocytolytic injectable treatment: results from a phase III, randomized, placebo-controlled study”;
B. Rzany,a T. Griffiths,b P. Walker,c, S. Lippert,d, J. McDiarmid,e, B. Havlickovad
aDivision of Evidence-Based Medicine in Dermatology, Charité-Universitätsmedizin, and
RZANY & HUND, Privatpraxis und klinisches Studienzentrum für Dermatologie, Berlin,
Germany;
bSalford Royal NHS Foundation Trust and Dermatopharmacology Unit, Faculty of
Medical and Human Sciences, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK;
cKYTHERA Biopharmaceuticals, Inc., Calabasas, CA, USA;
dGlobal Clinical Development Dermatology, Bayer HealthCare, Berlin, Germany;
eMcDiarmid-Hall Clinic, Derriford, Plymouth, UK DOI: 10.1111/bjd.12695
This study was one of two identically designed phase III clinical trials of ATX-101 conducted in Europe
The article in the BJD can be viewed online: http://onlinelibrary.wiley.com/doi/10.1111/bjd.12695/abstract
The British Association of Dermatologists is the central association of practising UK dermatologists. Our aim is to continually improve the treatment and understanding of skin disease. For further information about the charity, visit www.bad.org.uk
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