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STUDY: Green IRF Prestige - NON-ABLATIVE RADIOFREQUENCY ... · Amendment to Traditional 510(k)...

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Amendment to Traditional 510(k) Notification: Clinical Study Iskra Medical Green IRF Prestige and Accessories Page 1/11 STUDY: Green IRF Prestige - NON-ABLATIVE RADIOFREQUENCY FOR WRINKLE REDUCTION BORIS ONIŠAK, MD Head, ENT Department, General Hospital Murska Sobota Estetika Onišak, Private practice Slovenia Background and Objectives: This 5-month study evaluated the efficacy and safety of treatment with a nonablative radiofrequency (RF) device manufactured by domestic manufacturer Iskra Medical. Study Design/Materials and Methods: Forty-eight (48) patients were involved in the study. Each received 5 treatments with Green IRF Prestige in 2-week intervals, final evaluation was performed 3 months after last treatment. Results: The cosmetic outcome was evaluated by the patients and independent observers (2 doctors and a nurse). Additionally, independent observers scored the results according to the Fitzpatrick wrinkle assessment scale. 74% (34/46) of patients reported the wrinkle improvement as moderate or significant. Independent observers noted similar improvement – 81% (37/46) of patients experienced moderate or significant improvement. Assessment according to the Fitzpatrick wrinkle scale showed that 52% (24/46) patients had experienced 2-score improvement, and 18% (8/46) had had 3-score improvement. Side effects were mild. Rates and duration of erythema were very low. Conclusions: 5 treatments with this RF device produce both objective and subjective reduction in wrinkles. Although the results can not be compare with the ablative methods (lasers) or surgery, very mild and short-term side effects, low rate of pain, and repeatable procedure make this treatment acceptable for the patients. INTRODUCTION Several treatment modalities are currently available for treatment of facial wrinkles. Each of them has a specific effect on tissue, and more or less pronounced side effects. Ablative lasers and microdermabrasion significantly damage the epidermis, and require relatively long recovery time. Non-ablative light-based devices are more patient- friendly, but still relatively painful with potential long-term side effect. The radiofrequency device used in this study provides a rapid change of electric field polarity what alternately attracts and repels electrons and charged ions in dermis and hypodermis. The tissue’s natural resistance (impedance) to this movement produces heat, which activates both fibroblasts and production of new collagen. As this method ensures that no current flows through the epidermis, the skin surface is not exposed to heat, and therefore no superficial skin cooling is required. This way, more controlled, safer, and faster deposition of heat deep in the tissue is achieved by applying much lower energy than in the case of using the skin cooling. The purpose of this study was to evaluate the safety and efficacy the treatment of facial wrinkles and rhytids.
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Page 1: STUDY: Green IRF Prestige - NON-ABLATIVE RADIOFREQUENCY ... · Amendment to Traditional 510(k) Notification: Clinical Study Iskra Medical Green IRF Prestige and Accessories Page 1/11

Amendment to Traditional 510(k) Notification: Clinical Study Iskra Medical Green IRF Prestige and Accessories Page 1/11

STUDY: Green IRF Prestige - NON-ABLATIVE RADIOFREQUENCY FOR WRINKLE REDUCTION BORIS ONIŠAK, MD Head, ENT Department, General Hospital Murska Sobota Estetika Onišak, Private practice Slovenia Background and Objectives: This 5-month study evaluated the efficacy and safety of treatment with a nonablative radiofrequency (RF) device manufactured by domestic manufacturer Iskra Medical.

Study Design/Materials and Methods: Forty-eight (48) patients were involved in the study. Each received 5 treatments with Green IRF Prestige in 2-week intervals, final evaluation was performed 3 months after last treatment.

Results: The cosmetic outcome was evaluated by the patients and independent observers (2 doctors and a nurse). Additionally, independent observers scored the results according to the Fitzpatrick wrinkle assessment scale. 74% (34/46) of patients reported the wrinkle improvement as moderate or significant. Independent observers noted similar improvement – 81% (37/46) of patients experienced moderate or significant improvement. Assessment according to the Fitzpatrick wrinkle scale showed that 52% (24/46) patients had experienced 2-score improvement, and 18% (8/46) had had 3-score improvement. Side effects were mild. Rates and duration of erythema were very low.

Conclusions: 5 treatments with this RF device produce both objective and subjective reduction in wrinkles. Although the results can not be compare with the ablative methods (lasers) or surgery, very mild and short-term side effects, low rate of pain, and repeatable procedure make this treatment acceptable for the patients. INTRODUCTION Several treatment modalities are currently available for treatment of facial wrinkles. Each of them has a specific effect on tissue, and more or less pronounced side effects. Ablative lasers and microdermabrasion significantly damage the epidermis, and require relatively long recovery time. Non-ablative light-based devices are more patient-friendly, but still relatively painful with potential long-term side effect. The radiofrequency device used in this study provides a rapid change of electric field polarity what alternately attracts and repels electrons and charged ions in dermis and hypodermis. The tissue’s natural resistance (impedance) to this movement produces heat, which activates both fibroblasts and production of new collagen. As this method ensures that no current flows through the epidermis, the skin surface is not exposed to heat, and therefore no superficial skin cooling is required. This way, more controlled, safer, and faster deposition of heat deep in the tissue is achieved by applying much lower energy than in the case of using the skin cooling. The purpose of this study was to evaluate the safety and efficacy the treatment of facial wrinkles and rhytids.

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MATERIALS AND METHODS Study Design This study evaluated the efficacy and safety of a nonablative RF based device for the treatment of wrinkles. Each patient received 5 courses of RF treatment with a standardized algorithm. The results were evaluated 3 months after the final treatment. Degree of improvement was assessed by both the patients and the independent observers (dermatologist, plastic surgeon, and nurse of our clinic). According to the degree of improvement, the results were divided into five groups: worse, no change, mild, moderate and significant. Independent observers also evaluated treatment efficacy with the Fitzpatrick Wrinkle Classification System (FWCS) 3 months after final treatment. During their clinic visits (within 24 hours after each treatment and 3 months after the final treatment), patients were also evaluated for potential adverse effects. Study Population Initially, 48 patients aged 35 to 60 years were enrolled in the study. All of them were female patients with the skin type I to IV. Major exclusion criteria included blepharoplasty, surgical face lift or chemical peel treatments within 1 year, and collagen implants or usage of botulinum toxin within 6 months. RF Device Radiofrequency treatment was performed with the new radiofrequency system equipped with built-in calibration system for automatic selection of frequency (according to the tissue we intended to treat). Intensity was set between 70 to 100%, we used continuous mode of operations – pause was set to 0 s. This radiofrequency is actually capacitive monopolar radiofrequency with two electrodes – applicator and reference electrode. Both plates are insulated from the tissue what ensures that electric current flows only from one plate to another through the device – but does not flow through the tissue/patient. Instead of electric current, electric field is generated in the tissue what exerts a force on electrically charged objects. Therefore, tissue heating is produced due to rotation of the molecules in the electric field. Such movement can occur only in the tissue that contains water, not in stratum corneum, so the heat is not generated in this particular skin layer. That in fact prevents the skin surface from temperature increase, so no superficial skin cooling is required in order to protect the skin surface. Consequently, most of the heat is deposited in dermis and subcutaneous tissue – exactly where it is needed. The increase in skin surface temperature we measured is due to transfer of heat from the deeper skin layers to the surface (from hot to cold). Treatment Procedure No special pre-treatment procedure was performed. We provided only the standard superficial skin cleansing with cleansing milk and non-alcohol tonic. The skin was thoroughly dried before starting radiofrequency procedure. No anesthesia was applied. After the treatment, we advised the patients to use the cream chosen according to their skin condition (moisturizing, for oily skin, anti-pigmentation, etc.), to avoid direct sun exposure, and to use sun blocks. The radiofrequency was administered to entire face region. We divided the treatment site into 5 regions as shown on the Fig. 1.

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Each region was treated until the temperature at the skin surface reached 40 to 42 degrees Celsius. The end point temperature was kept for about-4 minutes, then we moved to treat another region. The temperature was measured with non-contact IR thermometer (Fluke). The entire treatment time was 30 to 45 minutes, depending on how fast the end point temperature was reached. The photographs were taken before the first treatment, after each treatment and 3 months after the final treatment.

Fig. 1: Treatment regions The frequency was set by the built-in calibration system for automatic selection of frequency (according to the tissue we intended to treat). Intensity was set between 70 to 100%, we used continuous mode of operations – pause was set to 0 s. Efficacy Outcomes For objective wrinkle evaluations, photographs obtained at baseline were compared with photographs taken at 3-month follow-up visit. All photographs were masked to block treatment settings, and treatment time. Three independent observers rated the wrinkles on each photograph according to our scale and the FWCS (Table 1). Table 1: The Fitzpatrick Wrinkle Classification System

Class Wrinkling Score Degree of Elastosis

I Fine wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines)

II Fine to moderate depth wrinkles Moderate number of lines

4-6 Moderate (distinct popular elastosis - distinct papules with yellow translucency under direct lightening - and dyschromia)

III Fine to deep wrinkles Numerous lines With or without redundant skin folds

7-9 Severe (multipapular and confluent elastosis – thickened yellow and pallid – approaching or consistent with cutis rhomboidalis)

Wrinkles were classified into the nine Fitzpatrick subgroups by the blinded observers and then again during the post-treatment clinic visit at 3 months. Independent observers did not refer to pre-treatment photographs while making post-treatment wrinkle assessments.

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Both patients and independent observers rated the cosmetic outcome at 3 months after treatment by assigning a ranking of worse, no change, mild improvement, moderate improvement, significant improvement. Safety Outcomes With each RF application, the patient called out the level of procedural pain (on a 5-point scale where 0 = no pain and 4 = intolerable pain). Adverse events were also noted. We documented observations of signs and symptoms related to the treatment area immediately after and within 24 hours of treatment, and then again at each patient visit. RESULTS Study Population Of the 48 subjects enrolled into the study, 46 completed all 5 RF courses. Two patients dropped out after the second treatment. The study population was fairly diverse in terms of age (35 to 60 years) and skin type on the Fitzpatrick scale. Skin types were pre-dominantly Type II and III, but ranged from Type I to Type IV. Fitzpatrick subclasses 3 to 8 were represented in the study population at baseline, with an average independent observers-assigned FWCS score of 5.8 (Table 2). Efficacy The cosmetic outcome was evaluated by both patients and independent observers.

Fig. 2: Patient and independent observer evaluation of cosmetic outcome

0

5

10

15

20

25

Worse No change Mild Moderate Significant

Independent observer

Patient

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This graph shows the degree of improvement assessed by patients and independent observers 3 months after 5 RF treatments in 2-week intervals. Total number of patients was 46. Nobody of the patients rated the treatment result as worse, 7% noted no change, 19% considered the improvement as mild, 30% as moderate, and 44% experienced significant wrinkle improvement. Independent observers classified the results as: 0% worse, 5% no change, 19% mild, 26% moderate, and 55% significant improvement. We noted almost no result after the second treatment, the improvement started to show up after the third treatment. Fiztpatrick Evaluation Table 2: The Fitzpatrick Wrinkle Classification assessment at baseline and 3 months after last treatment

Class Scores Baseline 3 months after final tx

I 1 0 (0%) 1 (2%)

2 0 (0%) 4 (9%)

3 3 (7%) 14 (31%)

II 4 6 (13%) 15 (33%)

5 14 (31%) 6 (13%)

6 7 (15%) 5 (10%)

III 7 11 (24%) 1 (2%)

8 5 (10%) 0 (0%)

9 0 (0%) 0 (0%)

Fitzpatrick subclasses 1 to 7 were represented in the study population 3 months after last treatment, with an average independent observers-assigned FWCS score of 3.9. Table 3: The Fitzpatrick Wrinkle Classification assessment – improvement in scores

Degree of Improvement No. of Patients

Worse 0 (0%)

No improvement (same score) 2 (4%)

Improvement 1 score 12 (26%)

Improvement 2 scores 24 (52%)

Improvement 3 scores 8 (18%)

Improvement 4 scores and up 0 (0%)

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The evaluation according to the Fitzpatrick Wrinkle Classification showed that no patient had experienced the worsening of the condition, 4% had had no change, 1-score improvement had been seen in 26% of patients, in 52% 2-score improvement, and in 18% 3-score improvement. We did not notice 4 score or better than that improvement.

Fig. 3: 56-year old patient before and 3 months after last tx

Fig. 4: 60-year old patient before and 3 months after last tx

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Fig. 5: 48-year old patient before and 3 months after last tx

Fig. 6: 37-year old patient before and 3 months after last tx

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Fig. 7: 41-year old patient before and 3 months after last tx

Fig. 8: 52-year old patient before and 3 months after last tx

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Safety As we used no anesthesia, we asked each patient to score the pain according to the following scale: 0 – no pain, 1 – mild pain, 2 – moderate pain, 3- severe pain, 4 – intolerable pain. The results are summarized in Table 3. Table 4: Pain during the treatment

Pain No. of Patients Percentage

No pain (0) 27 59

Mild pain (1) 14 30

Moderate pain (2) 5 11

Severe pain (3) 0 0

Intolerable pain (4) 0 0

The only noted side effect was erythema. Table 4 shows the number of patients that experienced this side effect and its duration. Table 5: Side effect – erythema after the treatment

Erythema Immediately after tx 24 h after tx

2 weeks after tx

3 months after final tx

No. of patients 46 6 0 0

Percentage 100 13 0 0

No edema, blistering, scaring or burns were observed. CONCLUSIONS We found this radiofrequency device safe and effective for wrinkle reduction. Although obtaining the positive results requires 5 treatments in 2-week intervals, very mild and short-term side effects reduced to erythema only compensate the required number of treatment sessions. It was also noted that in general the patients with more pronounced wrinkles (Fitzpatrick scores 6 to 8) experienced better results (improvement 2 to 3 scores) what is quite opposite what we found out in our previous study on IPL wrinkle reduction. Additionally, the expected side effects of radiofrequency treatment do not depend on the by the Fitzpatrick skin phototype as was the case in IPL treatments. Further studies may evaluate the risks and benefits of additional treatment sessions.

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REFERENCES 1. Sadick NS, Makino Y. Selective electro-thermolysis in aesthetic medicine: a review. Lasers Surg Med. 2004;34:91-97 2. Dover JS, Zelickson B, Multispecialty Consensus Panel. Results of a survey of 5,700 patient monopolar radiofrequency facial skin tightening treatments: assessment of a low-energy multiple-pass technique leading to a clinical end point algorithm. Dermatol Surg. 2007;33(8):900-907 3. Biesman BS, Pope K. Monopolar radiofrequency treatment of the eyelid: a safety evaluation. Dermatol Surg. 2007;33(7):794-801 4. Gold MH, Goldman MP. Treatment of wrinkles and skin tightening usin Aluma Skin Renewal System with FACES (Functional Aspiration Controlled Electrothermal Stimulation) technology. Lumenis Product Literature, October 2005:1-4 5. Gold MH, Goldman MP, Rao J, Carcamo AS, Ehrlich M. Treatment of wrinkles and elastosis using vacuum-assisted bipolar radiofrequency heating of the dermis. Dermatol Surg. 2007;33(3):300-309 6. Friedman DJ, Gilead LT. The use of hybrid radiofrequency device for the treatment of rhytides and lax skin. Dermatol Surg. 2007;33(5):543-551 7. Carruthers J, Carruthers A. Shrinking upper and lower eyelid skin with a novel radiofrequency tip. Dermatol Surg. 2007;33(7):802-809 8. Fisher GH, Jacobson LG, Bernstein LJ, Kim KH, Geronemus RG. Nonablative radiofrequency of facial laxity. Dermatol Surg. 2005;31(9):1237-1241 9. Finzi E, Spangler A. Multipass vector (Mpave) technique with nonablative radiofrequency to treat facial and neck laxity. Dermatol Surg. 2005;31(8):916-922 10. Mayoral FA. Skin tightening with a combined unipolar and bipolar radiofrequency device. J Drugs Dermatol. 2007;6(2):212-215 11. Ruiz-Esparza J. Nonablative radiofrequency for facial and neck rejuvenation. A faster, safer, and less painful procedure based on concentrating the heat in key areas: the ThermaLift concept. J Cosmet Dermatol. 2006;5(1):68-75 12. Narins DJ, Narins RS. Non-surgical radiofrequency facelift. J Drugs Dermatol. 2003;2(5):495-500 13. Lack EB, Rachel JD, D’Andrea L, Corres J. Relationship of energy settings and impedance in different anatomic areas using a radiofrequency device. Dermatol Surg. 2005;31(12):1668-1670 14. Dierickx CC. The role of deep heating for noninvasive skin rejuvenation. Lasers Surg Med. 2006;38(9):799-807

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15. Alster TS, Tanzi E. Improvement of neck and cheek laxity with a nonablative radiofrequency device: a lifting experience. Dermatol Surg. 2004;30(4):503-507 16. Koch RJ. Radiofrequency nonablative tissue tightening. Facial Plast Surg Clin North Am. 2004;12(3):339-346 17. Fritz M, Counters JT, Zelickson BD. Radiofrequency treatment for middle and lower face laxity. Arch Facial Plast Surg. 2004;6(6):370-373 18. Kushikata N, Negishi K, Tezuka Y, Takeuchi K, Wakamatsu S. Non-ablative skin tightening with radiofrequency in Asian skin. Lasers Surg Med. 2005;36(2):92-97 19. Ruiz-Esparza J, Gomez JB. The medical facelift: a noninvasive, nonsurgical approach to tissue tightening in facial skin using nonablative radiofrequency. Dermatol Surg. 2003;29(4):325-332 20. Abraham MT, Chiang SK, Keller GS, Rawnsley JD, Blackwell KE, Elashoff DA. Clinical evaluation of non-ablative radiofrequency facial rejuvenation. J Cosmet Laser Ther. 2004;6(3):136-144 21. Weiss RA, Weis MA, Munavalli G, Beasley KL. Monopolar radiofrequency facial tightening: a retrospective analysis of efficacy and safety in over 600 treatments. J Drugs Dermatol. 2006;5(8):707-712 22. Nahm WK, Su TT, Rotunda AM, Moy RL. Objective changes in brow position, superior palpebral crease, peak angle of the eyebrow, and jowl surface area after volumetric radiofrequency treatments to half of the face. Dermatol Surg. 2004;30(6):922-928


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