Evaluation of a New Adipocytolytic Solution: Adverse Effects and Their Relationship With the Number of Vials Injected
December 2014 | Volume 13 | Issue 12 | Original Article | 1451 | Copyright © 2014
Hernán Pinto MD,a Carlota Hernández MD,b Cinara Turra MD,c Marisa Manzano MD,d
Laura Salvador MD,d Paloma Tejero MDe
aInstituto de Investigaciones para las Especialidades Estéticas y del Envejecimiento, Barcelona, Spain
bClínica Arts Médica, Valencia, Spain
cBeyou Medical Group, Málaga, SpaindAntiaging Group, Barcelona, Spain
eClínica Mediestétic, Toledo, Spain
Adipocytolytic therapies have always raised the interest of aesthetic medicine physicians, mainly because of the great potential to achieve spectacular results in localized adiposities reduction. In the last few decades, these results have been severely compromised due to the improper or reckless injection of these products, to the extent of some of them being banned in many countries. Today, there is a new adipocytolytic solution that has been approved, is effective, and has theoretic and empiric consensus regarding its safety. The aim of this study for which 331 therapeutic sessions were retrospectively analyzed is to provide evidence of its safety and efficacy.
J Drugs Dermatol. 2014;13(12):1451-1455.
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The struggle to reduce the buildup of undesired adipose tissue in the human body is a century old.1 After the revolution brought about by Klein´s liposuction innovations during the 90’s, development of treatments for non-localized lipodystrophias blossomed and become wellestablished while development of localized lypodystrophia treatments stopped.2,3 A few years later, phosphatidylcholine and sodium deoxycholate solutions gained recognition for their great capability for achieving results4,5 and their relatively easy application. New research results have intensified an already established discussion6 regarding a mechanism of action that is not 100% understood, even today.7 Theorization continued8 and the local vs systemic effects analysis got most of the attention.9 The first effectiveness results started to appear,10 but “off-label” uses,11 sometimes even reckless, and the use of these products by non-qualified personnel, undermined society’s confidence in this kind of procedures.
Today, there is an adipocytolytic solution that has become the starting point of a new generation of injectable products for localized fat reduction. It is commercialized in Europe as a medical device. New evidence for localized adiposity treatments with sodium deoxycholate surfaces on a daily basis.12,13 However, the data available is almost exclusively focused on clinical results.14,15 Other than empiricisms,16 there is virtually no information of any kind regarding this procedure. In spite of this, it is important to stress that by the end of 2012 over 120,000 vials of this product had already been injected in Spain and up to that moment, to the best of the authors’ knowledge, there had been no reports of ulcers, skin necrosis, or irreversible functional deficit due to the use of this specific product. The absence of reports (even if the data is biased to some extent) after such a huge number of applications suggests that this product is safe.
The primary aims of this study are to a) perform a descriptive analysis of the side effects that occurred after treatment and b) to evaluate the effect of the number of vials injected on the side effects recorded. A secondary aim was to analyze whether other variables such as gender, body mass index (BMI), age, number of previous sessions, total number of injected areas, and number of vials injected in each area may alter the influence of the number of vials injected on side effects.
MATERIALS AND METHODS
In the present study, 331 sessions on 145 patients who received treatment between July 1, 2011, and June 30, 2012, were analyzed. Each patient who fulfilled the inclusion criteria and was treated during this period was included. Inclusion criteria were as follows: a) 25-65 years old; b) 19.5-29 BMI; c) no systemic pathologies; d) not under chronic medication or treatment; e) not pregnant or breastfeeding; f) no other treatment in the same areas within a month prior to the first session; g) adipose panicle minimum thickness: 1.5 cm; h) application areas were limbs and trunk. The product injected was Aqualyx®, Ghimas S.p.a., Casalecchio di Reno, Italy. as per the technical specifications.17 Each therapeutic vial consisted of the 8 ml commercial presentation unit and 0.2 ml of lidocaine 2% (no epinephrine) added to it. Special 100mm/24G and 70mm/25G needles were used for injection.