EFFECTIVE AND SAFE TREATMENT OF FACE, ARMS AND NECK,WRINKLES, RHYTIDES AND SKIN LAXITY USING A MULTISOURCEP H A S E C O N T R O L L E D R A D I O F R E Q U E N C Y D E V I C E S 1 2 3 4

INTRODUCTION

The effects of dermal heating are widely accepted to includethe modification of collagen structure and stimulation ofnew collagen production. These changes can help improvingthe appearance of fine rhytides or skin that has begun tolose its elasticity. Dermal heating may be achieved eitherdirectly via ablative laser skin resurfacing, or indirectlythrough the intact epidermis via a process often referred toas 'non-ablative skin resurfacing' or 'sub-surface resurfacing'.The 1320nm Nd:YAG laser was the first device developedspecifically for non-invasive dermal heating and it has provento be highly useful in the treatment of acne scars, depressedscars, and fine wrinkles. This type and other infrared lasersof its kind, primarily exert a relatively superficial effect.Although this laser can be effective at treating fine wrinklesand shallow acne scars, it does not produce deep dermaltissue tightening or lifting effects. To achieve more dramaticskin-tightening, deeper heating is required.

Electrical energy can be advantageous for deep dermalheating as, compared with light energy, the movement ofelectrons is not impeded by tissue proteins. RF energy heatstissue by creating electric fields between two electrodescausing molecules to rotate or move millions of times persecond to create heat. Resistance varies with the nature ofthe tissue,(skin versus fat, for example), temperature, andwater content.

The first systems implementing bipolar (two electrodes) RFhave shown some limited benefit due to the superficial flowof energy between the bipolar electrodes [4]. Other systemsthat implement monopolar (or unipolar) RF configurationuse a single electrode, which allows the energy to flowuncontrolled through the body. In this case, the energyspreads beyond the target area, and as such, the use of thistype of system is frequently associated with pain and otherlocal and systemic safety concerns.

Vider Itzhak MD2, Harth Yoram MD2,, Elman Monica MD, Gottfried Varda PhD3, Shemer Avner MD4, Beit HarofimMedical Center, Holon, Israel1, Medical OR, Medical Center Herzlya, Israel2, EndyMed Ltd. Cesarea, Israel3,SacklerSchool of Medicine, Tel Aviv University, Tel Aviv, Israel4

2 13 3 4

1 2 3

4

© 2009 EndyMed Ltd. All rights reserved.

The effects of dermal heating are widelyrecognized to include the modificationof collagen structure and stimulationof neocollagenesis. These changes canhelp improve the appearance of finerhytides or skin that has begun to loseits elasticity.Since laser or other light sources havelimited ability to penetrate the depth ofthe skin, radiofrequency (RF) devicesare a first choice for treatment ofwrinkles and lax skin. In this study, wetested the efficacy and safety of a novelmultisource phase controlled, RF devicethat delivers energy to the depth of theskin with significantly decreased risk.Eighteen patients completed the courseof the treatment protocol. A total of 20areas were treated: face (n=15 - 75%);abdomen (n=2 - 10%); arms (n=2-10%); and neck (n=1- 5%). For ourpurposes, we only analyze here theresults relating to the face and neck.In our study, the improvement in thewrinkle appearance was reported in 85-90% of the patients as judged by pictureana lys i s by b l inded rev iewers .Computerized surface and contouranalysis of the photographic resultsrevealed significant improvement ofskin texture, and in jaw line and chincontours. No unexpected adverse effectswere detected or reported.

ABSTRACT

1

2,

The EndyMed 3DEEP™ technology overcomes thesedrawbacks by implementing an array of several RFsources, controlling the phase of current flowingbetween each pair. Since adjacent electrodes possessan identical polarity, no current is created betweenthese electrodes on the skin surface. The multipledeep electrical fields created repel each other, leadingto precise delivery of energy directed and fullycontained to the dermal and hypodermal targets.

The EndyMed 3DEEP™ technology provides theability to deliver constant power customized in real-time to the individual patient's skin impedance,improving the predictability of results. .Uniquecontact motion and temperature sensors integratedinto the treatment hand piece allow optimal safety.

We examined the treatment results of 18 patientstreated for wrinkles in two clinical centers.

All 18 patients, all women, ages 39-71 years (average52.40±10.34), were enrolled in the study aftermeeting all inclusion/exclusion criteria and providingsigned Informed Consent Forms. The patients' skinwrinkles were classified according to FitzpatrickWrinkle Scale (2). (Table 1) A total of 4 body areaswere treated - face, abdomen, arms and neck; wherethe face was the most requested area for treatment(75%). Patients received three to eight treatments(average 4.8±1.32 treatments), spaced at intervalsof one to two weeks. Follow-up was carried outfrom one to f ive months af ter t reatment .

Prior to the RF treatment, the treated areas wasassessed visually as to skin relevant parameters andphotographed in a standardized method using high-resolution digital photography. This permittedcomparison and assessment of wrinkle appearanceimprovement following treatment. Photographs weretaken prior to each treatment.

The treatment area was cleaned thoroughly with soapand water. The skin surface was dried prior to thetreatment. Based on the patient's skin type and area oftreatment, the physician adjusted the pulse power (W).All patients had six passes of 30 sec each on eachtreatment zone (approximately 10cmx10cm).

The study's efficacy endpoint was considered bypre-treatment photographs that were assessed andgraded by two physicians blinded to the study andthe patients. Assessment of treatment efficacy wasperformed using the Fitzpatrick wrinkle scale. Anywrinkle score improvement (downgrade score)following treatment, relatively to pre treatmentwrinkle score , was considered a success .

The safety of the procedure was also evaluated bymonitoring the occurrence of potential procedurerelated side effects. Patients were asked to evaluatethe degree of pain during treatment. Immediatelyfollowing the treatment the treated area was visuallyassessed for skin responses, including edema,erythema, hypopigmentation, hyperpigmentation,and textural changes.

All 18 patients completed the course of the treatmentprotocol. A total of 20 areas were treated: Face (n=15- 75%); abdomen (n=2 - 10%); arms (n=2- 10%);and neck (n=1- 5%).

No unexpected adverse side effects were detectedor reported. In some patients, post treatment erythema

© 2009 EndyMed Ltd. All rights reserved.

MATERIALS AND METHODS

RESULTS

2

Table 1.Fitzpatrick wrinkle scale.

(hyperemia) was detected which was resolved within10 to 30 minutes. No patients experienced burns,skin breakdown, or scarring. None of the patientshas reported pain during the study.

All patients (100%) were very satisfied fromtreatment results. The following sets of before andafter photographs (Figures 1-4) illustrate thesignificant beneficial effect achieved with thismultisource phase controlled radiofrequency system.

© 2009 EndyMed Ltd. All rights reserved.

3

Figure 1:Female XX years o ld . [Lt]Before treatment. [Rt]After 6 treatments;there is evidenced as i g n i f i c a n t a n t i -wrinkles effect. Noticeimprovement underthe chin and jaw linecontours, including al i f t ing e f fec t andtexture improvement.Below is a texturei m a g e a n a l y s i s ,performed by ImageJ(National Institute ofHealth, USA).

Figure 2:Female XXyears old. [Lt] Beforetreatment. [Rt] After6 t r e a t m e n t s ;s i g n i f i c a n t a n t iwrinkle effect, andimprovement underthe chin and jaw linecontours , lifting effecta n d t e x t u r eimprovement. Belowis a texture imageanalys is , ( ImageJNational Institute ofHealth, USA).

© 2009 EndyMed Ltd. All rights reserved.

4

Figure 3: A 71-year old female;(Left) prior to firsttreatment; (Right)f o l l o w i n g t w otreatments.

Figure 4: A 47-year old female(Left) prior tofirst treatment;( R i g h t )following fivetreatments.

Photographic analysis of pre-and post treatment ofthe digital images was conducted by two blindedBoard certified dermatologists. Analysis revealedimprovement (downgrade of at list 1 score accordingto the Fitzpatrick scale) in 18 of the 20 treated areas(90%), according to the first reviewer, and 17 outof 20 treated areas (85%) according to the secondreviewer. Statistical comparison of the pre-and-posttreatment Fitzpatrick scores was conducted (usingpaired TTest) for each reviewer.

Score differences (pre and post treatment) was foundto be statistically significant (p<0.05) for bothreviewers indicating treatment efficacy. Furthermore,no statistical significance were found (p>0.05) whilecomparing the Fitzpatrick scores given by the tworeviewers pre treatment, and post treatment,indicating that the two blinded reviewers were inagreement regarding wrinkles assessment, pre andpost treatment. Figure 5 represents averages (±STDV) of Fitzpatrick scores given by the tworeviewers pre-and-post treatment.

© 2009 EndyMed Ltd. All rights reserved.

5

Figure 5: averages (± STDV) of Fitzpatrick scoresgiven by the two reviewers pre-and-post treatment.

The data reported in our study demonstrate that thisRF device offers a safe and effective noninvasivetechnique to improve the appearance of age-relatedrhytides and lax skin. The clinical results ofnonablative RF anti wrinkle effects were firstreported in the periorbital area (3). In this multicenterstudy, Fitzpatrick and his colleagues demonstratedclinical improvement in periorbital rhytides in 80%of subjects. In contrast, in 24 patients who underwenta single RF treatment to improve the upper third ofthe face, only 36% of the patients' self-assessmentreported improvement (4).

In our study, the improvement in the wrinkleappearance was reported in 85 and 90% respectively,of the patients by blinded reviewers.

In a similar study it has been reported that the useof a RF device was associated with significant pain,and in a small but significant number of casessubcutaneous fat atrophy developed (5). Nosubcutaneous fat atrophy was noted in our patients.In our study, all treatments were performed withoutany anesthesia, and yet were regarded by all patientsas pain-free. In fact, no patients considered theprocedure intolerable at any session.

The results of this study clearly indicate that thisinnovative RF system offers a non invasive, effective,safe and virtually painless wrinkle reductiontreatment.

In conclusion, the data reported in this study supportthe effectiveness of the Imagine™ ComputerizedRadiofrequency System in the treatment of wrinkles.

[1] Biesman B. Non-invasive Skin Tightening. US Dermatology review. 2006.

[1] Sadick N, Sorhaindo L. The radiofrequencyfrontier: a review of radiofrequency and combinedradiofrequency pulsed light technology in aestheticmedicine. Facial Plast Surg 2005;21: 131-8.

[2] Goldman p & Fitzpatrick E: Cutaneous LaserSurgery - the art and science of selectivephotothermolysis page 377; Mosby 1999.

[3] Fitzpatrick R, Geronemus R, Goldberg D, et al;Multicenter study of noninvasive, radiofrequencyfor periorbital tissue tightening. Lasers Surg Med2003;33:232-42.

[4] Bassichis BA, Dayan S, Thomas JR; Use ofNonablative radiofrequency device to rejuvenatethe upper one-third of the face. Otolaryngol HeadNeck Surg 2004;130: 397-406.

[5] Biesnman BS. Radiofrequency Devices:Monopolar vs bipolar vs radiofrequency plus laser;ind ica t ions ; t r ea tment approaches ; nove lapplications; results. In: Arndt KA, Dover JS,Anderson RR, edi tors . Controvers ies andConversations in Laser and Cosmetic Surgery.Symposium Proceedings; 2005, Denver, CO.

CONCLUSIONS

REFERENCES