Raffaele Rauso

A CE-Marked Drug Used for Localized Adiposity Reduction: A 4-Year Experience

BACKGROUNDnInjectable fat-reducing therapies are not an alternative to liposuction. Rather, they may be best suited for patients who are unwilling or unable to undergo surgical reduction of small collections of fat, and for patients who desire touchups for liposuction-induced irregularities.nnnOBJECTIVESnThe authors report their 4-year experience with a novel injectable CE-marked drug, used in an off-label manner.nnnMETHODSnBetween October 2009 and November 2013, 186 patients were treated by injection of an adipocitolytic solution in 1 of 4 private Italian aesthetic facilities, by 1 of 4 independent physicians. Treated areas included the neck, hips/saddlebags, abdomen/love handles, inner thighs, and buffalo hump. Complications and side effects were documented.nnnRESULTSnAll patients experienced mild to moderate swelling and reddening of the skin, which resolved 3 to 5 days after injection. No major complications or side effects occurred, such as necrosis. Rates of transient events were as follows: hematoma, 1.61%; paresthesia, 1.07%; and ecchymosis, 6.45%. Pruritus was reported by 21.5% of patients, which began 3 to 7 days following injection. Subcutaneous nodules were noted in 1.61% and resolved within 4 months of injection. A transitory unusual sensation was reported by 12.9% of patients, which lasted up to 2 months after final injection.nnnCONCLUSIONSnResults demonstrate that this CE-marked agent appears to be effective and safe for medical treatment of fat reduction.

5-year study of a polyacrylamide hydrogel-based filler for rehabilitation of HIV-related facial lipoatrophy.

BACKGROUNDnLipoatrophy of the face negatively impacts the quality of life and body image of individuals on antiretroviral therapy. Facial fillers can minimize the stigma associated with the human immonodeficiency virus (HIV).nnnOBJECTIVESnIn this 5-year follow-up study, the author assessed the safety and efficacy of a permanent, non-biodegradable, polyacrylamide hydrogel for facial volume restoration, and compared the results with those of a previous 18-month follow-up study.nnnMETHODSnThirty-one HIV-positive individuals, initially enrolled in the study between January 2008 and January 2009, received treatment of facial wasting by injection of the polyacrylamide gel until complete volume restoration was achieved. Asepsis rules were strictly observed before and during each injection session. Patients evaluated their aesthetic outcomes on a visual analog scale.nnnRESULTSnPatient satisfaction was high. There was no occurrence of local infection, foreign-body reaction, or product during the 5 years of follow-up. Small, palpable, nonvisible nodules were recorded in nine cases. It appears that these same nodules were present in the 18-month study. It is believed that the nodules were caused by overfilling in the same site.nnnCONCLUSIONSnAs supported by the initial 18-month study, polyacrylamide hydrogel filler appears safe and effective for the treatment of HIV-related lipoatrophy. With strict observation of asepsis rules and patient adherence to posttreatment instructions, this filler can be ideal for treating facial wasting in patients with HIV.nnnLEVEL OF EVIDENCEn3 Therapeutic.

Facial rejuvenation with fillers: The dual plane technique

Background: Facial aging is characterized by skin changes, sagging and volume loss. Volume is frequently addressed with reabsorbable fillers like hyaluronic acid gels. Materials and Methods: From an anatomical point of view, the deep and superficial fat compartments evolve differently with aging in a rather predictable manner. Volume can therefore be restored following a technique based on restoring first the deep volumes and there after the superficial volumes. We called this strategy “dual plane”. A series of 147 consecutive patients have been treated with fillers using the dual plane technique in the last five years. Results: An average of 4.25 session per patient has been carried out for a total of 625 treatment sessions. The average total amount of products used has been 12 ml per patient with an average amount per session of 3.75 ml. We had few and limited adverse events with this technique. Conclusion: The dual plane technique is an injection technique based on anatomical logics. Different types of products can be used according to the plane of injection and their rheology in order to obtain a natural result and few side effects.

Skin Necrosis Following Adipocitolitic Solution Injections

Injectable fat-reduction techniques emerged in the world literature in 2001, when Patricia Rittes, a dermatologist in Sao Paulo, Brazil, reported reduction of infraorbital fat after direct, transcutaneous injection of phosphatidylcholine (PC) combined with sodium deoxycholate (DC) solution.1 Despite lack of approval by any regulatory body, PC/DC combinations have been used off-label by healthcare practitioners to reduce subcutaneous fat in selected patients.2,3nnIn Europe, the only drug with CE marking (approval) for the reduction of localized fat is Aqualyx (Marllor International; San Giovanni in Marignano, Italy).4 Currently, it is approved in approximately 50 countries. Aqualyx is a DC-based solution with a lactose-based delivery system, formulated to control and enhance the action of external ultrasound waves for the microcavitation of adipose tissue.5 It does not contain PC. Aqualyx was designed for the medical treatment (reduction) of localized adipose tissue5 and is sold exclusively to physicians trained in intralipotherapy, the injection technique for its insertion.6 The product has been in clinical use since 2009 for the nonsurgical reduction of localized adiposity, lipohypertrophy, subcutaneous lipohyperplasia, and “buffalo hump”.6-8nnAqualyx is an aqueous microgelatinous solution comprised of the following: polymer of 3:6-anhydro-L-galactose and D-galactose; buffer systems; 3-alpha-12alpha-dihydroxy-5-beta-24-oico cholanic acid sodium salt; and saline solution.7,8 The solution appears similar in composition to DC, but it is considered a medical device—not a drug. A claim regarding this matter has been submitted to the Italian Ministry of the Health.8nnAqualyx is marketed as a 2-step product: immediately following injection (step 1), it is recommended that external ultrasonography be performed (step 2).5 However, …

Comments on "A Simple Device for Syringe-to-Syringe Transfer During Lipofilling".

I read with great interest the article by Dessy et al1 regarding use of the stopcock for syringe-to-syringe fat transfer during lipofilling.1nnStructural fat grafting is a standardized technique, originally described by Dr Coleman.2 When performing this procedure, it is crucial to be as gentle …

In Vitro Evaluation of the Biosafety of Hyaluronic Acid PEG Cross-Linked with Micromolecules of Calcium Hydroxyapatite in Low Concentration

OBJECTIVE: Neauvia Stimulate is biocompatible, injectable hyaluronic acid (HA) filler (26 mg/ml) PEG cross-linked with 1% of calcium hydroxyapatite (CaHA) for facial soft-tissue augmentation that provides volume to tissues, followed by process of neocollagenesis for improving skin quality. AIM: The aim of the present study is to evaluate the biosafety of the product (Lot. 160517-26-1/2 PEG) on human keratinocytes cultured in vitro. MATERIAL AND METHODS: The experimental model proposed, despite being an in vitro system, allows the derivation of useful information to predict the possible activity of the product in further in vivo application. Human keratinocytes (HaCaT cells) were treated with the product for 24h at increasing concentrations of product respect to control (untreated cells). RESULTS: The biosafety of the product to be tested has been evaluated performing different methods: MTT test, NRU test, Kenacid Blue assay. Moreover, any possible effect on the structure, morphology, and viability of cells has been evaluated. CONCLUSION: In conclusion, the results obtained by the different methods show that the product Neauvia Stimulate® does not cause any cytotoxic effect and does not affect the correct structure and morphology of cells cultures.

The Smart mastoplasty

F aging with change in facial shape and deepening of the Nasolabial fold, jowling and neck rhytids are some of the undesirable effects of the normal aging process. Face-lifting techniques continue to evolve with focus on different layers of the face to maximize and prolong the results. Regardless of the method used, best natural results are achieved by addressing five main areas: The neck platysma muscle, the Nasolabial fold, the Jowls, Fat and volume distribution and Symmetry. In this presentation we will present how to address these areas in the five step approach.This work is supported by national funds from FCT - Portuguese Foundation for Science and Technology, under the projects PTDC/AGRxadALI/105169/2008 and PEstxadOE/AGR/UI4033/2014.