Periorbital skin tightening with broadband infrared light device - Preliminary Results Elman Monica, MD* Elman Aesthetics Clinic, Rishon Le Zion, Israel Abstract Background and Objectives: Periorbital rhytides are often the first signs of aging skin for which young patients seek a non invasive, no downtime treatment Recently several skin tightening modalities based on deep dermal heating with various energy sources such as monopolar and bipolar radiofrequency as well as laser and broadband infrared light sources have been introduced to treat mild wrinkles and skin laxity The objective of this clinical study is to evaluate the safety and efficacy a new infrared system for the treatment of facial rhytides Methods: 11 subjects underwent 10 biweekly treatments primarily in the periorbital, and also in the malar and submental area Photographs were taken at base line, after 5, and in the end of treatment sessions, as well as at 1 and 2 months follow up visits Results were evaluated clinically and by comparing the photographs both by investigator and the subjects Results: Mean VAS Score (Assessed by the subjects) of 300 (out of 1-4 scale), and 309 (Assessed by practitioners) was obtained after 30 days and at 2 months follow up period respectively Pain and discomfort were maintained at a low to moderate level (1-2 out of 4) Local erythema and slight edema persisted for up to 2 hours o other side effects were recorded Conclusion: The new broadband, infrared skin tightening handpiece for Radiancy's Mistral LHE system is according to the interim results a safe and highly effective system for skin tightening and the treatment of textural signs of skin aging The procedure is comfortable for the patient with only minimal and transient side effects and no downtime Introduction Signs of aging in facial appearance can be significantly ameliorated by reduction of periorbital rhytides and skin laxity Use of broadband infrared (IR) light to induce skin tightening has been reported¹ This effect is achieved by utilizing tissue water as a chromophore for dermal heating consequently enabling shrinkage and neocollagenesis This report presents preliminary clinical results achieved with a new infrared light device specifically developed for aesthetic skin tightening by Radiancy Inc (Yavne, Israel) Materials and Methods A single site, open, clinical study was undertaken to assess safety and efficacy of the new IR skin tightening handpiece for the treatment of skin textural changes primarily in the periorbital area, and also evaluated in the malar area or submental area Eleven subjects were recruited to participate in the study Subjects were screened for inclusion and exclusion criteria and signed an informed consent form A series of ten (10) biweekly treatments were administered and followed up for a period of 2 months (3 months will be the final follow up period of the trial) Photographs were taken with a VISIA Complexion Analysis system (Canfield, USA) at baseline, after 5 treatments, at the end of the treatment sessions and during each monthly follow up visit Photography was carefully standardized since it is known 2 that skin textural changes tend to be subtle and may go undetected Treatments were administered with an average fluence of 17-18 J/cm 2 Treatment included 2-4 passes on the treatment area An ArTek Spot cooler (ThermoTek Inc) was used to cool the epidermis before and after IR energy administration The fluence applied was determined based on patient's feedback and immediate skin temperature measurement using a MiniTemp MT6 (Raytek Corp) noncontact thermometer Maximum skin temperature allowed was 42ºC which assures skin safety and patient comfort o anesthesia was necessary for the performance of this procedure 2008 by Radiancy Page 1
The result was evaluated clinically and by comparing the photographs obtained Evaluation was scored according to the following scale: 1 =no improvement; 2 = slight improvement; 3= good improvement; 4 = very good improvement During treatment the patient was requested to grade the discomfort level on a four-point scale (1 - no discomfort or pain, 2 - slight warmth, 3 - discomfort, 4 - intolerable heat or pain)this scale has been reported to be an effective method to guide treatment 3 Patient self assessment of the clinical improvement was also recorded throughout the trial period using a similar VAS score Patients were also asked to fill a patient questionnaire at the end of the treatment period Results Eleven subjects were enrolled in the study, all females aged 38 to 66, mean age of 51 years (SD: 79, median: 520 range: [38 66]), with skin Figure 1: Distribution of skin types types II to V All completed the full treatment and 2 months follow-up regimen Six of the eleven subjects (545) were classified as having skin type III, two (182) with skin type II, two (182) with skin type IV, and one (91) with a skin type of V (figure 1) 9 subjects (818) did not receive previous SR therapy The physician evaluated the primary and secondary treated area photos and graded them accordingly at baseline, end of treatment and end of follow up period (3 months) Table 1 presents the distribution of the VAS score as assessed by the investigator for the primary area Table 2 presents the distribution of the VAS score as assessed by the subjects The proportion of subjects with no improvement at 15 days of treatment was 182 (95 exact binomial Confidence Interval: [23-518]), at 30 days of treatment, it was 273 (95 exact binomial Confidence Interval: [60-610]), and at 1 and 2 months follow-up following the end of treatment, it was 00 (95 exact binomial Confidence Interval: [00-285]) The mean (±SD) VAS score (figure 3) at the 15 treatment days visit was: 241±044 (median: 25 range: [2 3]), and at the 30 treatment days visit: 300±000 (median: 3 range: [3 3]) Thus all subjects had shown some improvement by the 15 day visit and had further improved by the 30 day visit (figure 2) The mean (±SD) VAS score (figure 5,6) at the 15 treatment days visit was: 182±040 (median: 2 range: [1 2]), and at the 30 treatment days visit: 173±047 (median: 2 range: [1 2]), at the 1 month follow-up visit following the end of treatment: 273±065 (median: 3 range:[2 4]), Time Slight Improvement Good Improvement 15 Days 8 727 3 273 30 Days - - 11 1000 Table 1: VAS Score Assessed by the Investigator for the Primary Area (periorbital area) The proportion of subjects with no improvement at 15 days and at 30 days was 0 (95 exact binomial Confidence Interval: [00-285]) 2008 by Radiancy Page 2
Periorbital skin tightening with broadband infrared light device - Preliminary Results o Improvement Time Slight Improvement Good Improvement Very Good Improvement 15 Days 2 182 9 818 30 Days 3 273 8 727 1 Month FU 4 364 6 545 1 91 2 Months FU 3 273 4 364 4 364 Table 2: VAS Assessed by the Subjects Figure 2: Distribution of VAS Score Assessed by the investigator for the primary and secondary Area Figure 3: Mean (±SE) VAS Score Assessed by the investigator for the primary and secondary Area Figure 4: Distribution of VAS Score Assessed by the subjects 2008 by Radiancy Figure 5: Mean (±SE) VAS Score Assessed by the subjects Page 3
Figure 6: Mean (±SE) VAS Score Assessed by the subjects Figure 7: Distribution of pain levels by treatment An immediate heating and skin tightening effect was noted by all patients though pain and discomfort were maintained at a low to moderate level (pain score 1-2) Visible changes could be observed as soon as the fifth treatment (week 3) Textural changes persisted throughout the treatment and follow up periods Changes consisted of smoothening of periorbital wrinkles and a more radiant skin tone which produced an overall rejuvenated "new natural look" Projected heat from the treated area was felt for few minutes following treatment administration Local erythema and slight edema persisted for up to 2 hours o other side effects were recorded There was no need for analgesia The subjects reported after each treatment session the level of pain experienced during the session one of the subjects reported discomfort or intolerable heat during any of the sessions At the first and third session, 33 (one third) of the subjects did not feel any pain while the other two thirds felt only slight warmth During all remaining sessions, at least 50 of the subjects did not feel any pain at all while the rest felt only slight warmth (Figure 7) Discussion on ablative laser skin rejuvenation utilizing infrared wavelengths such as 1064, 1320, 1440 and 1540 nm has been clinically applied for almost a decade 4 to circumvent complications and prolonged convalescence often associated with ablative resurfacing techniques Only recently, however, broadband infrared devices have been introduced as an alternative to more costly laser systems Ruiz-Esparaza 5 was first to report on the use of broadband infrared (Titan, Cutera Inc) to produce skin contraction leading to lifting of eyebrows and/or improvement of lower face and neck skin laxity using fluences below pain levels A group of 25 patients were treated for eyebrow lifting, lower face tightening and neck skin laxity using fluences of 20-30 J/cm² Immediate skin contraction was obtained in 22 of 25 patients and was maintained for the whole follow-up period, up to 12 months Taub AF et al 2 confirmed these results in a retrospective, multi-center clinical study On 42 patients treated only twice at 1-month intervals, visible skin tightening improvement was observed on more than 90 of the patients o complications were observed and patient satisfaction was high Goldberg DJ et al 6 reported on the treatment of skin laxity of the lower face and neck in older individuals with a broad-spectrum infrared light device (Titan, Cutera Inc) Thirteen females aged 58-83 years old were treated twice at 1 month intervals Changes were dramatic for individuals in whom the skin envelope appeared to drape separately from deeper soft tissue Where skin stayed largely intact with subcutaneous tissue improvement was mild to moderate Improvement continued past the 1-month follow-up visit Chua SH et al 7 reported on the use of broadband IR for facial and neck skin tightening in type IV to V Asian skin Twenty-one patients underwent three treatment sessions spaced 4 weeks apart Final physician and patient clinical assessment was performed 6 months after treatment 28 were assessed by the physician as significantmild, 38 as significant-moderate and 19 as significant-excellent 19 of patients reported mild improvement, 38 reported moderate improvement and 43 reported good improvement Main side effect was isolated superficial blistering 2008 by Radiancy Page 4
Periorbital skin tightening with broadband infrared light device - Preliminary Results BL End of Tx Figures 8 & 9 BL After 4 Tx End of Tx Figures 10, 11 & 12 Carniol PJ et al8 reported on ten patients who received two broadband IR treatments for facial and cervical skin tightening Greatest tightening was found over the malar region, the upper neck and the body of the mandible In these areas average tightening was 10,10 and 20 respectively Patients reported 32 improvement in the appearance of their cheeks and 20 improvement in their necks and expressed mean overall satisfaction of 64 on a scale of 10 Finally, Kameyama K9 reported on histological and clinical effects of broadband IR on human and mouse skin 10 and 20 J/cm² IR light increased the amount of both collagen and elastin in all layers of the dermis without denaturing the collagen in human skin, while a higher dose of 30 J/cm² also increased the amount of collagen and elastin but denatured the collagen in human skin It was concluded that there are 2 mechanisms of skin tightening The first is the effect of deep heating to degenerate collagen while the second is the activation of mitochondria Increased amounts of ATP induced by phototherapy play an important role in the synthesis of various kinds of materials such as collagen and elastin IR sources applied in previously reported studies employ 2008 by Radiancy contact skin cooling for epidermal protection In the Radiancy IR skin tightening handpiece contact skin cooling has been replaced with a proprietary, multi-pulse algorithm which provides optimal deep dermal heating while preventing epidermal over heating Our initial clinical experience with this new device indicates similar safety and efficacy to previously reported broadband IR devices for skin tightening This device enables particularly attractive features for the esthetic doctor requesting a multi targeted platform that gives excellent answer for all of in office skin rejuvenation demands It is well suited for patients of all ages and may also be offered to young patients as a preventive skin anti-aging procedure Conclusion The new broadband, infrared skin tightening handpiece for Radiancy's Mistral LHE system is according to the interim results a safe and highly effective system for skin tightening and the treatment of textural signs of skin aging The procedure is comfortable for the patient with only minimal and transient side effects and no downtime Final clinical results will be published shortly Page 5
Consent Full verbal and written informed consent was obtained from the patients for the submission of this manuscript for publication with the accompanying images References 1 Dierickx CC The role of deep heating for noninvasive skin rejuvenation Lasers Surg Med 2006 Oct;38(9): 799-807 2 Taub AF, Battle EF, ikolaidis G Multicenter clinical perspectives on a broadband infrared light device for skin tightening J Drugs Dermatol, 2006 Sep; 5(8):771-8 3 Fitzpatrick R, Geronemus R, Goldberg D, Kaminer M, Kilmer S, Ruiz-Esparaza J Multicenter study of oninvasive radiofrequency for periorbital tissue tightening Lasers Surg Med 2003;33(4):232-42 4 Alexiades-Armenakas MR, Dover JS, Arndt KA The spectrum of laser skin resurfacing: onablative, fractional and ablative laser resurfacing J Am Acad Dermatol 2008;58:719-37 5 Ruiz-Esparza J ear (corrected) painless, nonablative, immediate skin contraction induced by low fluence irradiation with new infrared device: a report of 25 patients Dermatol Surg 2006 May;32(5):601-10 6 Goldberg DJ et al Treatment of skin laxity of the lower face and neck in older individuals with a broad-spectrum infrared light device J Cosmet Laser Ther 2007;9:35-40 7 Chua SH et al onablative Infrared Skin Tightening in Type IV to V Asian Skin: A Prospective Clinical Study Dermatol Surg 2007;33:146-151 8 Carniol PJ et al Facial skin tightening with an 1100-1800 nm infrared device J Cosmet Laser Ther 2008;10:67-71 9 Kameyama K Histological and Clinical Studies on the Effects of Low to Medium Level Infrared Light Therapy On Human and Mouse Skin J Drugs Dermatol, 2008 March; 7(3):230-5 * Contract grant sponsor: Radiancy LTD BL After 4 Tx 2008 by Radiancy Page 6