The european Journal of Aesthetic Medicine and Dermatology

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EJAMeDwww.ejamed.com

The European Journal of

Aesthetic Medicine and Dermatology

Volume 2, Issue 1, 2012 ISSN 2240-5046

Intralipotherapy Patient Satisfaction Evaluation

Study (IPSES)

Hernán Pinto1, Graciela Melamed2, Luca Fioravanti3

1Age Back, Barcelona

2MEG Group, Buenos Aires

3Thermalift Center, Pavia

Intralipotherapy represents an injection technique specifically studied for an appropriate and rational use of

injectable solutions with an adipocytolitic activity. The injection protocol, introduced in Italy in 2002 by P. Mo-

tolese is now widespread throughout Europe and is highly standardized and rigid with only small variations,

which are related to the composition of the solution being injected.

The main purpose of this study is to analyze patient satisfaction when undergoing an intralipotherapy treatment.

Secondary: assess whether satisfaction increases or not when performing a second intralipotherapy session.

Patients are very satisfied with the results of intralipotherapy treatments and are even more satisfied after per-

forming a second session.

KEYWORDS: Intralipotherapy, patient satisfaction, Adipocytolyses, Localized Adiposities, Aqualyx

Eur. J. Aesth. Medicine and Dermatology. 2012;2;(1):29-34

ABSTrACT

original ArticleThe European Journal of Aesthetic Medicine and Dermatology

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Hernán Pinto MDAgeback Clinic Roger de Lluria 26 Principal 2. B - 08010 Barcelona - Spainhpinto@ageback.es

Author disclose any commercial associations or financialdisclosures that might pose or create a conflict of interestwith information presented in the manuscript.

CorrESPoNDENCE DISCLoSurES

he non-surgical treatment of localizedadiposity underwent a fundamentalevolution around the year 2000

thanks to the off-label use of the pharma-ceutical Lipostabilâ (Sanofi-Aventis)(1),which is no longer in production, and thesubsequent introduction to the market ofthe injectable solution called Aqualyx®

(Marllor International). The injection proto-col called intralipotherapy was proposed byP. Motolese in 2002 in relation to the mech-anism of action of Lipostabilâ, erroneouslyinterpreted initially as lipolytic(2,3).The presence of a localized inflammatoryreaction (1), the poor receptor sensitivity tolipolytic stimuli particularly at the level of

INTroDuCTIoN

T

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the trochanteric region(4) and the remotepossibility that the phospholipids, notori-ously known for their capacity to repair andcontribute to the formation of the cell mem-branes(5), and the possibility is very remotethat the phospholipids, notoriously knownfor their capacity to repair and contribute tothe formation of the cell membrane, couldalso have a role of signalling hormone to ac-tivate the lipolytic process(6), indicated a dif-ferent mode of action of the drug. Thepresence of a detergent, sodium deoxy-cholate in the formula of Lipostabil® testi-fying to a lytic action of the latter on the cellmembranes. An ex vivo histological studyconducted by G. Salti e P. Motolese (datanot published in the literature) shows theadipocytolytic action induced by injectablesolutions containing molecules with a de-terging activity, which becomes even moreintense with the subsequent application ofexternal ultrasound.The injection intralipotherapy protocol wasborn as a result of understanding the mech-anisms of action of these injectable solu-tions and provides a rigid standardizedtechnical approach that guarantees a ho-mogenous distribution of the solution inadipose tissue without involving the deep-est muscle layer and the superficial dermalplane as is the case with the mesotherapy(intradermotherapy) technique(7).

M AT E R I A L S A N D M E T H O D S

Twenty-six (26) volunteers were included inthis study. All of them were women betweeneighteen and sixty years old, with no sys-temic pathologies, taking no medications,

not pregnant nor lactating and with no otherspecific intralipotherapy contraindications.All subjects had a BMI index(IMC=weight/height2) between 24 and 28 atthe beginning of the study.

From 30 days prior to the first session until21 days after the last Intralipotherapy ses-sion, the subjects were committed not toundergo any local nor general fat reductiontreatment, including: low caloric diets,lipocryolysis, fat reducing oral products, li-posuctions and other surgical procedures,mesotherapy, or carboxitherapy.

Experimental groups.

The study group consisted of twenty-sixwomen (n=26). 20 where treated in Spainand were randomly assigned to one of twogroups each consisting of 10 subjects, theremaining 6 were treated in Italy. All sub-jects received the same treatment, howevereach group received a different number ofsessions. Subjects in the first group (G1,n=10) received a single Intralipotherapysession, while subjects in the second group(G2, n=16) received two Intralipotherapysessions separated 21 days apart.

Product.

Intralipotherapy was performed with theAqualyx® product. Which is an aqueous so-lution with a microgelatinous base contain-ing a polymer of 3:6-anhydro-L-galctoseand D-galactose, buffer systems, 3-alpha-12-alpha-dihydroxy-5-beta-24-CholanoicAcid sodium salt, physiologic solution for

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injectable preparations and sodium chlo-ride. All together these components makeup the solution known as Motolese’s Solu-tion.Specific 100 mm intra-lipotherapyLipoinject® needles were used.After infiltration of the subcutaneous adi-pose tissue using the intralipotherapy pro-tocol, external ultrasound with Sonolyx®was applied to the treated area.

Samples.

Each participant had to fill out a self as-sessment questionnaire 21 days after eachsession. The first questionnaire (Q1) wasfilled out by all subjects 21 days after thefirst therapeutic session (S1). The secondquestionnaire (Q2) was filled out by G2 sub-jects 21 days after the second therapeuticsession (S2) (Figure 1).

Each questionnaire consisted of the follow-ing questions:

1. What did you like most about thistreatment?

2. What did you dislike most about thistreatment?

3. Describe the results you have noticed inyour body after the treatment with re-gards to localized fat.

4. If you received 2 therapeutic sessions,describe the differences you noticed inthe localized fat of the treated area, 3weeks after the first session and 3weeks after the second session.

5. Would you be happy to repeat this pro-cedure?

6. How frequently would you repeat a twoto three session protocol?

7. Would you recommend this procedureto friends and relatives?

8. From 1 (no results) to 10 (spectacularresults), rate the general results you sawin the treated areas.

9. From 1 (no results) to 10 (spectacular re-sults), rate the general results you sawafter the first session in the treated areas.

FIGURE 1. Questionnaire fulfilment schedule (Q1 and Q2) and sessions (S1 and S2) vs. time.

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10. From 1 (no difference from the first ses-sion) to 10 (spectacular improvementcomparing it to the first session), ratethe results you saw after the secondsession in the treated areas.

11. From 1 (not satisfied at all) to 10 (ab-solutely satisfied), rate your satisfactionwith the treatment.

12. If you received two sessions: how wouldyou describe your satisfaction compar-ing it after the first session and after thewhole treatment (the 2 sessions).

13. In general, would you say that this treat-ment reduced the localized fat in thetreated area?

14. Are you satisfied with the technique andthe procedure?

15. Do you think the product is relevant toachieving the results?

16. Do you think the physician is relevant toachieving the results?

Therapeutic session.

The application was divided into two zones:right and left peritrochanteric. A sessionconsisted in the application of one and ahalf vials of Aqualyx® in each of these twozones according to the extension of thearea to be treated and according to theposology suggested by the injection proto-col. The procedure took approximately 5minutes for every zone. The protocol usedwas the following:

- Indication-contraindication re-evaluation- Informed consent signature- Photography- Treatment area demarcation

- Antisepsis- Product injection- Ultrasound applicationA retrograde fan technique was used. Halfa millilitre of the solution was injected withevery stroke of the plunger. Two or three punc-tures where performed to treat a single zoneaccording with the intralipotherapy protocol.The same physician performed all sessions.

R E S U LT S

Different answers to the questions posed were:

Question #1.16 patients: results7 patients: no pain1 patient: everything2 patients: physician technique

Question #28 patients: needle length7 patients: “burning like” feeling when product was injected

4 patients: nothing2 Patients: did not answer4 patients: bruise (side effect)1 patient: feeling the needle movement

Question #313 patients: moderate fat reduction8 patients: spectacular fat reduction4 patients: slight fat reduction1 patient: very slight fat reduction

Question #4 (only group 2)14 patients: extra fat reduction1 patient: no difference1 patient: did not know

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Question #517 patients: doubtlessly6 patients: yes3 patients: did not know

Question#610 patients: every 6 months5 patients: early6 patients: whenever the physician advisesit3 patients: every two years 2 patients: every 3 months

Question #724 patients: yes2 patients: did not know

Question #811 patients: 85 patients: 94 patients: 102 patients: 72 patients: 51 patient: 61 patient: 3

Question #97 patients: 86 patients: 75 patients: 53 patients: 91 patient: 102 patients: 61 patient: 41 patient: 3

Question #10 (group 2)6 patients: 73 patients: 4

2 patients: 32 patients: 81 patient: 91 patient: 61 patient: 4

Question #1116 patients: very satisfied8 patients: satisfied2 patients: the treatment did not reach their expectations

Question #1215 patients: the same11 patients: increasedQuestion #1326 patients: yes

Question #1422 patients: yes4 patients: no

Question #1526 patients: yes

Question #1626 patients: yes

C O N L U S I O N

Itralipotherapy with Aqualyx® is a very sat-isfying treatment for localized adipose tis-sue reduction. Each subject included inthis study reported the noticeable localizedfat reduction in the treated areas. Thegroup that received the second in-tralipotherapy reported better results thanthe group that received a single session.The fat reduction reported with the secondsession was less than the fat reduction re-

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ported with the first session but was stillsignificant.

In a very statistically significant majority,this treatment generated great satisfactionfor the patients. Paradoxically, though fatreduction reported for the second sessionwas significant, satisfaction rates did not in-crease proportionally. Patient satisfactionwas so positively influenced by the impactof the clinical results of the first session thatthey kept a “very satisfied” opinion towardsthe procedure no matter what where theovercomes of the following sessions.

The evidence suggested that intralipother-apy is a very satisfying treatment for local-ized fat reduction.

R E F E R E N C E S

1. Rittes P: The use of phosphatidylcholine forcorrection of lower lid bulging due to promi-nent fat pads. Dermatol Surg 27:391, 2001

2. Hoffmann K.:Injection lipolysis Hautarzt.2010 Oct;61(10):847-55.

3. Môle B. A five years experience of subcuta-neous chemical lipolysis with phosphatidyl-choline injections. Ann Chir Plast Esthet.2011 Apr;56(2):112-9. Epub 2010 Oct 20.

4. H Wahrenberg, F Lönnqvist, and P ArnerMechanisms underlying regional differencesin lipolysis in human adipose tissue. J ClinInvest. 1989 August; 84(2): 458–467

5. Gordienko AD. The pharmacologic and bio-chemical effects of unsaturated phospholi-pids. Farmakol Toksikol. 1990Sep-Oct;53(5):78-81.

6. Motolese P. Phospholipids do not have lipo-lytic activity. A critical review. J CosmetLaser Ther. 2008 Jun;10(2):114-8. Review.

7. S. Maggiori: Manuale di intradermoterapiadistrettuale. EMSI Ed., 2004