Category: double chin


BACKGROUND

Recent articles have introduced the novel concept of chemical lipolysis through local injections. Phosphatidylcholine is the active drug in the commercial preparation used for this purpose, but some studies have suggested that sodium deoxycholate, an excipient of the preparation, could be the real active substance.

AIM

We decided to investigate whether phosphatidylcholine and sodium deoxycholate have any clinicalefficacy in chemical lipolysis and their respective roles. We also studied the safety and side effects of
the treatments.
MATERIALS AND METHODS

Thirty-seven consecutive female patients were studied for the treatment of localized fat in gynoid lipodystrophy. Each patient received injections of a phosphatidylcholine/sodium deoxycholate preparation on one side and sodium deoxycholate on the contralateral side, each single patient being herself the control. Four treatments were carried out every 8 weeks in a double-blind,  randomized fashion. Metric circumferential evaluations and photographic and ultrasonographic measurements throughout the study allowed for final judgment. A statistical evaluation concluded our study.

RESULTS

An overall reduction of local fat was obtained in 91.9% of the patients without statistically significant differences between the treated sides. Reduction values on the phosphatidylcholine/sodium deoxycholate–treated sides are in the order of 6.46% metrically and 36.87% ultrasonographically, whereas on the deoxycholate-treated sides they are in the order of 6.77% metrically and 36.06% ultrasonographically.
Both treatments, at the dose used in the study, proved safe in the short term. The most common side effects were local and few, but were more pronounced on the deoxycholate-treated sides.
No laboratory test was carried out.

CONCLUSION

Both treatments have shown moderate and equivalent efficacy in treating localized fat, with sodium deoxycholate having a slower postoperative resolution, suggesting that sodium deoxycholate could be sufficient by itself to determine fat cell destruction and that phosphatidylcholine could be useful for obtaining a later emulsification of the fat.
The authors have indicated no significant interest with commercial supporters.

CLICK HERE TO DOWNLOAD THE COMPLETE STUDY: http://www.superhumangear.com/store_wp/lipostabil_fatburning_study.pdf

 

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FAQs about Lipo-dissolve

Phosphatidylcholine/Deoxycholate Overview

What are lipo-dissolve injections?

Lipo-dissolve injections have become an increasingly popular means to remove excess fat. The procedure goes by many names (e.g., Lipostabil®, Lipodissolve, Flab-Jab, Lipojection, Lipotherapy, etc.) and involves the injection of mixtures of various chemicals into the fat through multiple microinjections administered over multiple treatment sessions. The desired end result is the gradual removal of localized fat deposits. Lipo-dissolve injections are generally not regarded by medical professionals to be as potent as liposuction, a powerful yet invasive surgical procedure in which multiple liters of fat are ‘sucked’ from patients in a single session. Lipo-dissolve therapy typically requires that dozens of small ‘fat burning’ injections of compounded phosphatidylcholine/deoxycholate (PCDC) be injected into fat and connective tissue over several sessions. These drugs are not FDA-approved.

What are the compounds/ingredients in the injectable solution?

The main compound used in lipo-dissolve is phosphatidylcholine (PC), a compound derived from soy that is a component of cell membranes in many organisms, including humans.1 Deoxycholate (DC), a naturally occurring bile salt produced by the liver, is also used in the formulation to solubilize phosphatidylcholine, thus keeping it in solution.1 Together, the main ingredients are commonly abbreviated as PCDC, however without a specific FDA-approved formulation for the injected solution, the ratio of the two compounds in a given formulation may be substantially different depending on the provider. Some providers also add small amounts of other medications, vitamins, and herbs. PCDC injections have not been approved by FDA for ANY indication and neither phosphatidylcholine nor deoxycholate are active ingredients in ANY FDA-approved drug.
Where do providers get the PCDC for lipo-dissolve injections?

The PCDC drug is obtained from compounding pharmacies, which traditionally make small quantities of unique drugs for specialized treatments (e.g., special versions of drugs for patients with allergic reactions). According to experts who discussed this issue with the Washington Post, in many situations involving compounded drugs, quality control and sterility can often be “spotty or nonexistent.”2
What is the standard lipo-dissolve procedure?

There is no standard process/procedure that has been studied in controlled clinical trials or to the satisfaction of the FDA. Therefore, the procedure will differ depending on the provider. FDA-approved drugs have a standardized drug formula and method of administration. With lipo-dissolve, individual providers determine dosing and technique. The lipo-dissolve procedure “typically” involves an average of 2-4 treatment sessions spaced 4-8 weeks apart.3According to the Aesthetic Surgery Journal, the maximum safe dose of PC is 100 mL per session with approximately 0.4 mL delivered with every micro-injection. However, because studies have not concluded a standard protocol outlining specific number of sessions, number of microinjections per session, and amount of PC needed for results, this average may vary greatly.4
How is the drug cleared from the body?

There is no scientific support for theories about how the drug is cleared from the body. It is unclear exactly how the body metabolizes and excretes the drug and the broken down fat cells. The injected chemicals are believed to trigger an inflammatory response as the fat cells are broken down and are thought to be excreted in the urine and feces. Without pharmacologic studies (those that study the compound’s mechanism of action and are required for FDA-approved drugs), these theories cannot be confirmed.
How long has the procedure been around? How many times has it been performed?

Cosmetic use of phosphatidylcholine injections was introduced at the First International Meeting of Mesotherapy in 1988 by Italian Physician Sergio Maggiori5. The formulation began being used for fat removal in Brazil in the 1990’s yet was later banned by ANVISA (Brazilian National Agency of Health Inspection). The procedure has only more recently been introduced in the U.S., and the American Society of Non-surgical Aesthetics estimates that 50,000 to 100,000 lipo-dissolve treatments have been performed in the USA and Europe6. Despite the numbers of treatments performed, the drug’s safety and efficacy cannot be confirmed without controlled clinical trials as required by the FDA.
I keep hearing different terms for the treatment (e.g., lipo-dissolve, advanced lipo-dissolve, lipotherapy, injection lipolysis, etc.), are they all the same thing?

The treatments are similar in that each typically involves the injection of an unapproved PCDC formulation.

What areas can be treated with injections?

Currently, people use PCDC in a variety of areas (chin, abdomen, thighs). However, no well-controlled studies have examined where in the body the drug may or may not work. There is no FDA-approval for this drug for any part of the body.

Does the phosphatidylcholine affect other cells in the body besides fat cells?

It is unknown whether the drug affects other cells in the body (such as muscle or nerve cells). While a “theory” has been proposed for the method by which phosphatidylcholine destroys fat cells, the scientific mechanism still is not well understood.7
Are the injections a proper treatment for weight loss?

Without FDA-approval, this answer is unknown. But according to lipo-dissolve providers, the answer is no. Lipo-dissolve is not a viable means to lose weight. The ideal candidate is at a healthy weight but possesses localized fat deposits that cannot be reduced by exercise and diet. Lipo-dissolve may be successful in reducing inches but may not show any reduction in actual weight.
Are the ingredients used for lipo-dissolve safe?

PCDC is an unapproved drug. According to physicians currently studying the procedure, “until more safety data becomes available, physicians may be placing patients at unknown risks as they become reliant upon a compounded formulation for these treatments.”8 Additionally, FDA has stated that “there are no FDA approved drugs with an approved indication to dissolve fat and FDA cannot assure the safety and efficacy of these types of drugs.”8

FDA Status
Is the drug approved by the FDA?

PCDC is not approved by the FDA for any use. Furthermore, neither PC nor DC alone are active ingredients in any FDA-approved drug. FDA has issued a statement warning consumers “there are no FDA-approved drugs with an approved indication to dissolve fat and FDA cannot assure the safety and efficacy of these types of drugs”9 and that this is a “buyer-beware situation.”9
I understand that the compounds in PCDC are naturally occurring substances in our body. If it’s natural, why is it considered a drug?

Just because something is a naturally occurring substance does not mean that it is not a drug. Take insulin, adrenaline, human growth hormone, and erythropoietin, for example. They are natural substances in our body, all are considered drugs, and all are extremely dangerous at the wrong dose. The FDA considers something a drug if it affects the structure and function of the body. PCDC providers claim that it does just that.

What does FDA-Approval mean?

In the United States, prescription drugs are required to undergo rigorous laboratory, animal, and human clinical testing before they can be put on the market. The FDA reviews results of these studies to verify the identity, potency, purity, and stability of the ingredients as well to verify that the drug is safe and effective for its intended use. PCDC has not undergone any of the necessary testing required for FDA-approval. For more information on the drug approval process and the benefits of using drugs that have been FDA approved, please see the BOTOX®/Lipo-dissolve comparison page outlining the difference between an FDA-approved drug versus a non-FDA approved drug.

If PCDC is not approved, does that mean it’s being legally used off-label?

No. According to FDA, “off-label” use involves using an “approved” drug for an indication not in the approved labeling at the discretion of a physician10. Since PCDC is not approved, its use cannot be considered “off-label.” For more information, see Differences Between Lipo-dissolve and BOTOX® page.

Futhermore, the FDA has stated, “We are not aware of any phosphatidylcholine injectable products or sodium deoxycholate injectable products that could be used ‘off-label’ in ‘lipodissolve’ procedures.” Read more…

What data exists to demonstrate the safety and efficacy of phosphatidylcholine injections?

It is important to note that there have been numerous retrospective studies (i.e. historical observations) performed on the use of phosphatidylcholine injections for fat dissolution1,2and a few prospective non-placebo-controlled studies performed to test the efficacy of the procedure.11 However, to date there have been no prospective, placebo-controlled studies (those required for FDA approval) done on the use of PCDC for fat removal and therefore safety and efficacy cannot be confirmed. Placebo-controlled studies are those where participants are randomly assigned to receive either the placebo or the active substance. Neither the participant nor the doctor know which treatment the participant receives. The goal of this type of trial is to illustrate that it is the drug that is eliciting a response, not the placebo. With retrospective studies, one makes conclusions based on pre-existing data (i.e. you start with an answer and look backwards to selectively find data that supports your conclusion). Prospective trials, as required by the FDA, by their very structure prevent this from happening.

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Journal of Drugs in Dermatology, Oct, 2009 by Patricia Guedes Rittes, Clarissa Rites

ABSTRACT

Background: The lower third of the face and neck have distinct changes that occur with aging: the lost of the perfect jaw line due to laxicity of skin and fat deposits associated with “turkey neck.” Theses changes can be globally and drastically addressed with traditional rhytidectomy, however patients increasingly seek less invasive procedures. Injections with Lipostabil–a mixture of phosphatidylcholine and deoxycholate, a bile salt–have been used to reduce unwanted, accumulated fat. Recent in vivo investigations indicate that phosphatidylcholine and deoxycholate cause adipocyte lysis, an inflammatory processes and fibrosis. These reactions lead to skin retraction.

Objective: This paper reports the author’s experience treating aging neck using Lipostabil Endovena.

Results: Laxity of the skin improved in all patients. A marked reduction in double chins was noted and the jaw line was reconstructed. Adverse effects, including transient burning, erythema and local swelling were present in all patients, but resolved themselves without intervention.

Conclusion: The author’s clinical experience supports the conclusion that Lipostabil Endovena treats subcutaneous fat tissue and that fibrosis after the inflammatory process retracts the skin, tightening the injected area and improving the aging neck.

INTRODUCTION

The aging neck is a common complaint in dermatological and plastic surgery offices. The lower third of the face and neck have distinct changes that occur with aging: the lost of the perfect jaw line due to laxicity of skin and fat accumulation associated with what is called “turkey neck.”

Treatment traditionally includes surgical excision or liposuction, depending on the characteristics of the laxity. Although effective, these treatments are associated with surgical risks, scarring and hematomas. Treatments that are minimally invasive and not associated with these risks would be ideal for patients reluctant to undergo surgery but who wish to improve the appearance of their necks.

Several open-label clinical trials have reported localized loss of adipose tissue using subcutaneous injections of a mixture containing phosphatidylcholine, a bile salt, and sodium deoxycholate as an excipient, (1), (2), (4-6) which is used to solubilize the soy lecithin-derived phospholipid (Lipostabil[R] Endovena).

Recent experimental investigation demonstrates that this mixture has a detergent action that produces fat cell lysis, necrosis and a desired inflammatory process. (3) The evolution of these processes might lead to fibrosis, which would be seen clinically as skin retraction.

In this article, a case study is presented of patients treated with subcutaneous injections using Lipostabil Endovena as a treatment for aging neck.

METHODS

After obtaining written informed consent for treatment, 15 patients with clinically diagnosed aging chins were injected with Lipostabil Endovena (250 mg/mL phosphatidylcholine). The medical histories reported by patients were not relevant, nor had the patients had previous interventions in the neck area. The same clinician who performed the injections also evaluated neck laxity and used pre-and post-treatment photographs to document the changes.

A 30-gauge 0.5-in needle attached to a 5 mL syringe was used to directly inject the solution subcutaneously into the subcutaneous fat. No ice or topical anesthetic was used. Patients were treated with 0.3 mL of solution at three sites located at the mid-jaw line on the left and right and under the middle of the chin. No pressure was applied directly to the sites of the injections and an elastic band was recommended for use the first two nights.

The patients’ clinical responses were recorded, including pain and erythema immediately after injection. Additional reactions occurring in the intervals between treatments were recorded by patients and reported during the subsequent visit. Intervals between injections were at least two weeks in length. Treatment consisted of one to four sessions. The study conformed to the guidelines of the 1975 Declaration of Helsinki.

RESULTS

A total of 15 patients with aging neck: 14 women and one man, aged 36-57 years of age with Fitzpatrick skin type 2-4, were injected with Lipostabil Endovena; observations are summarized in Table 1 and Figures 1-3.

All patients presented reduced aging neck after a mean of 2.6 treatments (seven patients were treated two times; six patients were treated three times and two patients were treated four times). The time interval between treatments ranged from two weeks to three months due to a number of factors unrelated to clinical response or treatment.

Notably, most patients treated experienced moderate burning within minutes of injection and mild sustained, localized swelling (two weeks). Ecchymoses occurred in two patients, both of whom bled at the injection site. No patient reported constitutional symptoms at any time during treatment.

Cosmetic improvement occurred in all patients. Pre- and post-procedure photographs were utilized to document the changes, as shown in Figures 1-3. All patients complained of a mild burning sensation following injections, typically lasting about 15 minutes. Immediately following the injections, infiltrative edema and local erythema were noted over the initial six hours and persisted for approximately 72 hours. All patients were followed for 1.5 years after the last treatment.

DISCUSSION

The procedure documented in this study offers a non-surgical alternative for improving the aging neck by reducing the excess of skin in this area.

The injections of Lipostabil Endovena contain phosphatidylcholine, which is typically combined with deoxycholate to facilitate suspension of the phospholipids in an aqueous solution. Deoxycholate is a secondary bile salt that has been incorporated as an emulsifier in intravenous medication. This detergent action was recently shown to produce human keratinocyte cell lysis in vitro (4) and the combination of both (Lipostabil Endovena) shows necrosis of adipose in rabbits in vivo. (3)

Based on this, the author presumes that after injection intensive necrosis occurred in the fat tissue, followed by an inflammatory process. This process would likely lead to fibrosis, which would be seen clinically as skin retraction. Patients may prefer minimally invasive procedures, even if the outcomes are less dramatic than more invasive techniques.

The safety of this procedure is based on 15 years experience injecting Lipostabil endovena inside the fat and the complications of this use was published in a recent retrospective study. (7),(8) The cosmetic results observed were satisfactory from the point of view of both the patients and the treating dermatologists. This study supports the use of a simple, non-surgical office-based procedure for treating aging neck.

Long-term follow up has reached the two-year mark with no return of local fat as long as there is no weight gain (over 4 kg).

DISCLOSURES

The authors have no relevant conflicts of interest to disclose.

REFERENCES

(1.) Rittes PG. The use of phosphatidylcholine for correction of lower lid bulging due to prominent fat pads. Dermatol Surg. 2001; 27(4):391-392.

(2.) Rittes PG. The use of phosphatidylcholine for correction of localized fat deposits. Aesthetic Plast Surg. 2003;27(4):315-318.