Evaluation of safety and efficacy using venus freeze by dr neil sadick
Evaluation of Safety and Efficacy of Using Venus Freeze® System for Wrinkles and Rhytides Treatment - a Post Marketing Study Neil Sadick, MD Clinical Professor, Dermatology – Weill Cornell Medical College*.INTRODUCTION PATIENTS AND METHODSPatient demand for non-surgical, non-invasive, All 31 patients, (1 male, 30 female), ages 36-62and no-downtime wrinkle treatment procedures years (average 49.23±7.17), were enrolled inhas grown dramatically over the past decade as the study after meeting all inclusion/exclusionnew treatments and technologies have been criteria and providing signed Informed Consentintroduced. Form.The effects of dermal heating are wellrecognized to include immediate effects on The patients’ skin wrinkles were classifiedcollagen structure with stimulation of according to Fitzpatrick Wrinkle Scale(2). Table 1neocollagenesis (1). presents the Fitzpatrick Wrinkle Scale. All 31 patients were treated for face wrinkles andThese changes can help reduce the rhytides.appearance of fine wrinkles. Radiofrequency(RF) energy is used in medicine for a few Patients received 10 treatments – the first fourdecades. Radiofrequency (RF) energy heats treatments were performed twice weekly, thetissue through the induction of rotational 5th-10th treatments were performed once amovement in water molecules. These week. Subjects were scheduled for two follow-movements produce heat and in turn affect up visits – 1 month and 3 months following lastcollagen for wrinkle reduction. treatment.Multiple Monopolar and Bipolar RF devices are Prior to the RF treatment - the treated areasFDA cleared for non ablative treatment of were assessed visually as to skin relevantwrinkles and rhytides and for skin tightening. parameters and photographed in a standardized method using high-resolution digitalVenus Concept has developed the Venus photography in order to allow comparison andFreeze® system for wrinkles and rhytides assessment of wrinkle appearancetreatment. The Venus Freeze® system improvement following treatment. Photographsincorporates a power supply, RF generator, a were taken prior to each treatment.computer controller and treatment hand pieces.The applicator controls the heating of one ormore target tissues (epidermis, dermis andhypodermis). While treating wrinkles andrhytides, the treatment creates enough thermaleffect to induce collagen remodeling with noablative thermal damage of the epidermis ordermis. Table 1: Fitzpatrick wrinkle scale.A post marketing study was conducted in orderto evaluate the efficacy and safety of the Venus The treatment area was cleaned thoroughly withFreeze® system, an innovative system intended soap and water. The skin surface was driedfor wrinkles treatment. Altogether, 31 subjects prior to the treatment. Treatment parametersparticipated in the study. Subjects were treated were determined by the operator and werefor facial wrinkles and followed for 3 months based on patient skin type and area offollowing last treatment. In order to evaluate treatment. The following parameters weretreatment efficacy, pre and post treatment chosen:photos were introduced to two uninvolvedphysicians for blinded evaluation. Treatment time (min) Output Energy (Watt)The following report describes the cumulativeresults of this study.
Immediately after the treatment the treated areawas visually assessed for skin responses,including edema, erythema, hypopigmentation,hyperpigmentation, and textural changes.In addition, patients were asked to rate the painlevel which they felt during the treatment byusing analogue pain scale. The study’s efficacyendpoint was considered by pre-treatmentphotographs (baseline) that were assessed andgraded by two physicians blinded to the studyand the patients.Assessment was conducted by using Fitzpatrickwrinkle scale. Any wrinkle score improvement(downgrade score) following treatment,relatively to pre-treatment wrinkle (baseline)score, was considered a success.The safety of the procedure was also evaluatedby monitoring the occurrence of potentialprocedure-related side effects.Patients were asked to evaluate the degree ofpain during treatment. In addition, treated areaswere visually assessed for skin responses,including edema, erythema, hypopigmentation,hyperpigmentation, and textural changesfollowing each treatment.RESULTSAll 31 patients completed the course of the 10treatments and 3 months follow-up protocol. No unexpected adverse side effects were detected or reported. In some patients, post treatment edema (hyperemia) was detected. The edema was resolved within 10 to 30 minutes. No patients experienced burns, skin breakdown, or scarring. None of the patients has reported pain during the study. All patients (100%) were satisfied with treatment resultsThe following sets of before and afterphotographs (Figure 1, 2, 3 and 4) illustrate thesignificant beneficial effect achieved by theVenus Freeze® System.
Photographic analysis of pre-and post treatment DISCUSSION AND CONCLUSIONSof the digital images was conducted by a boardcertified dermatologist and a board certified Thirty one patients were treated for face wrinkleplastic surgeon. reduction and followed for 3 months following last treatment. In order to evaluate treatmentAnalysis revealed improvement downgrade of at efficacy, pre and post treatment photos werelist 1 score according to the Fitzpatrick scale in introduced to two uninvolved physicians foralmost all (96.7%) patients according to both blinded evaluation.reviewers. Statistical comparison (using pairedT-Test) was conducted among the pre- The data reported in this study demonstrate thattreatment Fitzpatrick score (baseline) to Venus Freeze® device offers a safe andFitzpatrick score obtained at the 3 monthsfollow-up (following 10 treatments) for each effective noninvasive technique to improve thereviewer. appearance of age-related rhytides and wrinkles.Statistical analysis was conducted by SAS (9.1).Score differences were found to be statistically The clinical results of nonablative RF antisignificant while comparing baseline score to wrinkle effects were first reported in thethe scores obtained at 3 months follow-up periorbital area(3). In this multicenter study,(p<0.001) for both reviewers, indicating Fitzpatrick and his colleagues demonstratedtreatment efficacy. Table 2 and Figure 4 clinical improvement in periorbital rhytides inrepresent averages (± STDV) of Fitzpatrick 80% of subjects. In contrast, in 24 patients whoscores given by the two reviewers at baseline underwent a single RF treatment to improve theand 3 months follow-up. These results may upper third of the face, only 36% of the patients’indicate that the treatments have initiated self-assessment reported improvement (4) .collagen remodeling process that continuesafter treatment session has been completed. In this study, statistical analysis has revealedAll 31 patients participating in the study reported improvement (downgrade of at list 1 scoreno pain during the treatment. according to the Fitzpatrick scale) in almost all (96.7%) patients according to both reviewers. Analysis of study results has revealed statistical significance while comparing baseline score to the scores obtained at 3 months follow-up, following 10 treatments for both reviewers, indicating treatment efficacy. In a similar device, it has been reported that the use of an RF device was associated with significant pain, and in a small but significant number of cases subcutaneous fat atrophy developed (5). No subcutaneous fat atrophy was noted in this study. All patients participating in the study have reported no pain during treatment, although procedure was performed without using any anesthetic agents. Furthermore, no patients considered the procedure intolerable at any session.
The results of this study clearly indicate that thisinnovative RF system offers a non-invasive,effective, safe and virtually painless wrinklereduction treatment.In conclusion, the data reported in this studysupport the safety and effectiveness of theVenus Freeze® System for wrinkle and rhytidestreatment.REFERENCES1. Sadick N, Sorhaindo L. The radiofrequencyfrontier: a review of radiofrequency andcombined radiofrequency pulsed lighttechnology in aesthetic medicine. Facial PlastSurg 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, etal; Multicenter study of noninvasive,radiofrequency for periorbital tissue tightening.Lasers Surg Med 2003;33:232–42.4. Bassichis BA, Dayan S, Thomas JR; Use ofNonablative radiofrequency device torejuvenate the upper one-third of the face.Otolaryngol Head Neck Surg 2004;130: 397–406.5. Biesnman BS. Radiofrequency Devices:Monopolar vs bipolar vs radiofrequency pluslaser; indications; treatment approaches; novelapplications; results. In: Arndt KA, Dover JS,Anderson RR, editors. Controversies andConversations in Laser and Cosmetic Surgery.Symposium Proceedings; 2005, Denver, CO.* Study was not physically conducted at theWeill Cornell Medical College