- NON-SURGICAL FACIAL TREATMENT

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1 - NON-SURGICAL FACIAL TREATMENT Alex Levenberg, M.D. Physician s Center, Plastic Surgery Dept., Tel Aviv, Israel / June of 12

2 Abstract: Objective: To evaluate the safety and efficacy of the apollo device for facial treatments. Methods: Seven female subjects underwent facial treatments once a week using the apollo system. The system is equipped with both a medium and a small applicator specifically designed for facial treatments. Results were objectively recorded and analyzed with a three-dimensional imaging system. Results: Following the apollo facial treatments, an improvement of perioral and periorbital wrinkles was achieved and analyzed using the Primos imaging system. Conclusions: Findings demonstrated the safety and efficacy of the apollo treatment protocol for facial skin tightening. Treatments resulted in tighter, lifted skin with improvement of fine lines and wrinkles. Introduction Fine lines, wrinkles and sagging skin are common aesthetic problems associated with the aging process. On average, adult skin loses approximately 1-2% of its dermal collagen deposits every year. The primary causes are degeneration of existing collagen fibers and reduced production of dermal structural proteins, such as collagen and elastin, by the fibroblasts. Surgical face lift procedures are relatively popular among patients seeking to reverse the signs of aging; however, these invasive treatments are not the first choice for those who prefer a mild and gradual change. Various non-invasive skin rejuvenation methods such as lasers, IPL, IR and radio-frequency (RF) have emerged in recent years to treat the signs of aging and offer an alternative for surgery-averse patients. These treatments usually result in increased dermal collagen regeneration leading to skin tightening and rejuvenation and can be performed in a simple lunch time clinical procedure. Technology The apollo device is based on TriPollar technology- a leading 3 rd generation RF technology, developed and marketed by Pollogen Ltd. Three or more electrodes, designed to deliver focused RF current deep into the skin, generate heat through resistance in both the dermal and subcutaneous layers. The penetration depth and clinical effect on the various skin layers depend on the design and distance between the electrodes. In the dermal skin layer, selective and focused electroheating is intended to stimulate collagen production and remodeling, resulting in wrinkle reduction and skin tightening. As opposed to traditional skin rejuvenation methods which treat from the epidermis down towards the deeper dermal layer, TriPollar focuses the effect on the dermal layer and acts within the skin. As a result, the epidermis remains protected and there is no need for active cooling of the electrodes or the skin. RF is not sensitive to skin tone and therefore the TriPollar treatment is suitable for all skin types. The use of RF to tighten the skin is based on the ability of RF, a form of electromagnetic energy, to generate heat through rapidly oscillating electromagnetic fields which cause movement of charged particles within the tissue. The thermal effect results in shrinkage of redundant or lax connective tissue through the mechanism of collagen denaturation. 2 of 12

3 Collagen molecules are produced by fiborblasts which synthesize three polypeptide chains that wrap around one another in a triple helix. The phenomenon of thermal shrinkage of collagen begins with a denaturization of the triple helix of the collagen molecule (Ref 1). When collagen is heated, the heat-labile cross-links are broken, and the protein undergoes a transition from a highly organized crystalline structure to a random, gellike state (denaturation). This structural change of collagen fibers results in an immediate, short term clinical effect of skin tightening. In addition, heating the fibroblasts stimulates new collagen formation and subsequent tissue remodeling, a process which takes a few weeks and contributes to the final long lasting non-surgical face lift result. The precise heat-induced behavior of connective tissues (and the extent of tissue shrinkage) is dependent on several factors which include the maximum temperature reached, exposure duration, tissue hydration and tissue age. The apollo system consists of a main unit, three applicators, a foot switch and a bio-feedback control (Figure 1). The three applicators are specifically designed for treatment of various body and facial areas and thus differ in size and configuration. Applicator No. 1, with a large treatment area is indicated for the treatment of large body areas. Applicator No. 2 with a medium treatment area is indicated for the treatment of facial areas and for medium sized or curved body areas such as the arms and hands. Applicator No. 3 with a small treatment area is specifically indicated for treatment of very small and delicate facial areas such as the perioral and the periorbital areas. Its unique design enables easy and safe approach to the challenging areas around the mouth and the eyes. Both the medium and small sized applicators (No. 2 and No. 3 respectively) can be used for the treatment of hands. The operator can adjust treatment parameters, such as the power level and treatment duration, through the user interface on the Main Unit. Treatment power, exposure time and allocation of applicators can be custom tailored to the patient. For instance, more time can be devoted when treating problematic areas in order to achieve better non-surgical results. Figure 1: apollo device and applicators - large, medium and small Objective The evaluation was intended to assess the safety and efficacy of the apollo device for non-invasive treatment of facial wrinkles and skin tightening, using applicator 2 combined with applicator 3. 3 of 12

4 Methodology Seven healthy female subjects, aged (mean 50.7), received an average of 7 facial treatments once a week with the apollo system (range of 4-10 treatments, number varied according to individual conditions and specific needs). Two additional subjects received hand treatments. Facial treatments were performed using a combination of the apollo medium and small applicators. The small applicator was mainly used for delicate facial areas such as perioral and periorbital wrinkles. The average treatment time was minutes, occasionally longer, depending on the patient s skin condition. Results were evaluated using photographs taken with a digital camera and through objective evaluations carried out using a three-dimensional (3-D) micro-topography imaging system (PRIMOS, GFM, Teltow, Germany). This imaging system projects light onto a specific surface of the skin with a Digital Micro-mirror Device (DMD; Texas Instruments, Irving, Tx) and records the image with a CCD camera. Skin surface micro-topography is reconstructed using a temporal phase shift algorithms to generate 3-D images. This objective technique has been previously deployed to provide rapid and quantitative assessment of skin surface topography and facial fine lines following treatments with non-ablative laser or other cosmetic procedures, correlating well with clinical and subjective responses (Ref 2, 3). 3-D topographic photos of perioral and periorbirtal areas were taken before and after the treatment using the overlapping feature of the Primos, enabling precise matching of the photos taken at different visits. Objective PRIMOS photograph evaluation was based on volume analysis and wrinkle depth analysis. The analysis was performed on patients that had a significant reduction of wrinkles and that the depth and size of the reduction was visually apparent in the digital photos and through the Primos 3-D wrinkles representation (by the reduction in intensity of dark colors, mainly blue - Figures 4, 5, 8, 10, 12). Volume analysis represents the estimated volume (or occupied space) of skin cavities such as: fine lines, wrinkles or skin depressions in a marked area below a reference plane. Volume analysis was conducted using 3-D topographic photos of perioral and periorbital areas taken before and after treatments. The photos taken before and after treatment were matched and the volume of a defined area was compared. The size of the marked areas differed from one patient to the other, according to the visual improvement detected in the 3-D photos. Volume reduction was calculated as: (Vb-Va)/Vb (b- before, a- after). For wrinkle depth analysis, a single line was marked on the 3-D photo, across the same wrinkle before and after the treatment. The lines were analyzed and presented as a cross-sectional graph representing the depth of each line. Wrinkle depth analysis was measured according to the distance / height difference between two points of a cut-line which passed through two defined points: one at the curve before and the second at the curve after the treatment (Figures 4, 5, 8, 10, 12). Clinical Results: Short-term Immediate effect: Slight erythema and/or edema were detected at the end of the treatment as demonstrated by photos and Primos results, and generally lasted for a few hours and up to 1 day. This immediate effect contributed to the overall tightening and firming of the skin and softened the appearance of facial fine lines and wrinkles. Transient erythema and/or edema indicate that the energy reached the tissue and stimulated collagen regeneration leading to long term therapeutic effect. Examples of immediate results are presented in Figures of 12

5 Figure 2: Example of immediate results. Professional photos. Left: Before, Right: Immediately after one treatment. Figure 3: Example of immediate results. Primos periorbital photos. Left: Before, Right: Immediately after one treatment. 5 of 12

6 Wrinkle depth: Before After Volume: V1-0.73; V ^%-73% Figure 4: Example of immediate results (same patient as in Figure 3). Primos 3D periorbital photos. Left: Before, Right: Immediately after one treatment. Area of wrinkle depth and volume analysis is marked. 6 of 12

7 Wrinkle depth: Before After Volume: V1-8.3; V2-4.2 ^%-42% Figure 5: Example of immediate results. Primos 3D perioral photos. Left: Before, Right: Immediately after one treatment. Area of wrinkle depth and volume analysis is marked. 7 of 12

8 Long Term results: Patients benefited from long term results following a full treatment session. As shown in the sample photographs below (Figures 6-12), the TriPollar treatment significantly reduced the appearance of wrinkles and tightened the skin. Figure 13 demonstrates results of hands skin rejuvenation. No significant adverse effects were detected during the study period. Subjects scored their sensation during the facial TriPollar treatment on a 5 score scale where 1 signified very uncomfortable and 5 signified extremely comfortable. 85.7% of the patients rated their sensation as comfortable to extremely comfortable with an average comfort score of 4.1. Figure 6: Example of long term results (8 treatments), in a 68 year old patient. Professional photos. Left: Before, Right: After eight treatments. 8 of 12

9 Figure 7: Example of long term results (same patient as in Figure 6). Primos Periorbital photos. Left: Before, Right: After eight treatments. Wrinkle depth: Before After Volume: V1-8.4; V2-4.8 ^%-42.8% Figure 8: Example of long term results (same patient as in Figure 6). Primos 3D periorbital photos. Left: Before, Right: After eight treatments. Area of wrinkle depth and volume analysis is marked. 9 of 12

10 Figure 9: Example of long term results (5 treatments). Professional photos. Left: Before, Right: After five treatments. Figure 10: Example of long term results (same patient as in Figure 10). Primos 3D perioral photos. Left: Before, Right: After five treatments. Area of wrinkle depth and volume analysis is marked. 10 of 12

11 Figure 11: Example of long term nasolabial fold results (3 treatments). Primos 3D nasolabial photos. Left: Before, Right: After three treatments. Wrinkle depth: Before After Volume: V1-11; V2-7.4 ^%-32% Figure 12: Example of long term nasolabial fold results (same patient as in Figure 11). Primos 3D nasolabial photos. Left: Before, Right: After three treatments. Area of wrinkle depth and volume analysis is marked. 11 of 12

12 Figure 13: Example of hands treatment of 82 year old patient. Left: Before, Right: After two treatments. Courtesy of Ms. Sharon Friedman. Summary: The apollo device, based on TriPollar technology, is a safe and effective method for the treatment of wrinkles and sagging facial skin resulting in skin tightening and improved facial appearance. Following a treatment session with the apollo facial applicators, most patients benefited from immediate as well as long term results. The treatment is applicable for all skin types. The unique small size applicator provides an added value for treating wrinkles at delicate and hardly accessed facial areas such as perioral and periorbital. References: 1. Arnoczky SP, Aksan A. Thermal modification of connective tissues: basic science considerations and clinical implications. J Am Acad Orthop Surg Sep- Oct; 8(5): Review. 2. Friedman PM, et al. 3D in-vivo optical skin imaging for topographical quantitative assessment of non-ablative laser technology. Dermatol Surg Mar;28(3): Fujimura T, et al. Global and systematic demonstration for the practical usage of a direct in vivo measurement system to evaluate wrinkles. Int J Cosmet Sci. 2007; 29(6): Rev 1, August of 12

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