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Beauty Lumenis’ LightSheer Technology Bibliography of Studies & Peer Reviewed Papers ® PB-2000876 Rev A

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Lumenis’ LightSheer TechnologyBibliography of Studies & Peer Reviewed Papers

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About Lumenis

Lumenis is a global leader in the field of minimally-invasive clinical solutions for the Surgical, Ophthalmology and Aesthetic markets, and is a world-renowned expert in developing and commercializing innovative energy-based technologies, including Laser, Intense Pulsed Light (IPL) and Radio-Frequency (RF). For nearly 50 years, Lumenis’ ground-breaking products have redefined medical treatments and have set numerous technological and clinical gold-standards. Lumenis has successfully created solutions for previously untreatable conditions, as well as designed advanced technologies that have revolutionized existing treatment methods in each and every one of the verticals we operate in. Our drive for innovation stems from an uncompromising commitment to improving the health and well-being of our patients; addressing new and growing needs of aging populations; and in offering medical professionals cutting-edge solutions that fit seamlessly into the health-economics environment of the 21st century. The world over, we bring Energy to Healthcare.

www.lumenis.com

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Table of Contents

Laser hair removal 5

Peer reviewed articles 5

White papers 15

Asian skin hair removal 18

Dark skin hair removal 19

Vascular Lesions and Pigmented Lesions 22

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Abbreviations

LHR Laser Hair Removal

WL Wave Length

DL Diode Laser

IPL Intense Pulsed Light

FU Follow Up

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BibliographySTUDY TYPE TITLE AUTHORS RESEARCH SITES PUBLICATION YEAR LANG.TOPIC ABSTRACTSTUDY TITLE AUTHORS MAIN ARTICLE CONCLUSIONS PUBLICATION YEAR TYPEABSTRACTMAIN TOPICS

Peer reviewed article

Safety and Long term efficacy comparison between Light-Sheer® XC and IPL

Photoepila-tion with a Diode Laser vs. Intense Pulsed Light (IPL): ARandomized, Intra-Patient Left-to-Right Trial

A. Klein, S.Steinert, W. Baeumler, M. Landthaler, P. Babilas

• Treatment with LightSheer®

XC is more effective (after 12 months follow up) than IPL treatment.• LightSheer® XC treatmenttime is faster than IPL

Br J Dermatol. 2013 Jun;168(6):1287-93.

2013 BACKGROUND: Safe and efficient options for removing unwanted hair are in great demand. Laser devices and intense pulsed light (IPL) sources are the most commonly used treatment modalities. Yet, only a few randomized controlled trials (RCTs) comparing laser and IPL devices are available, and RCTs with long-term results are missing in the literature.OBJECTIVES: To compare the safety and long-term efficacy of diode lasers (DL) and IPL sources for axillary hair removal, we conducted an intra-patient,left-to-right, assessor-blinded and controlled trial. METHODS: IPL (Ellipse Flex PPT, Danish Dermatological Development, Hoersholm, Denmark; λem = 600-950 nm) and DL (LightSheer® XC system, Lumenis Inc., Santa Clara, CA, USA; λem = 800 nm) treatments were evaluated in 30 study participants (skin type II-III) with unwanted axillary hair growth. Six treatments with each device were carried out in 4-week intervals. Final assessment was conducted 12 monthsafter the last treatment by means of hair counts using close-up photographs. Primary endpoint was reduction in hair growth, analysed on an intention-to-treat and last- observation-carried-forward basis (n=30), and secondary endpoints were patient- rated efficacy, treatment-related pain, adverse effects and treatment duration. RESULTS: Both devices significantly reduced hair counts. Mean reductions from baseline (3 and 12 months after the last treatment) were 59.7% and 69.2% for DL and 42.4% and 52.7% for IPL treatment (p < 0.01). DL treatment induced significant more pain (3.7 ± 2.1 (DL) vs. 1.6 ± 1.4 (IPL); p < 0.01; visual analogue scale) but could be conducted faster (33.1 ± 3.8 s (DL) vs. 40.1 ± 5.0 s (IPL); p < 0.01). No severe side effects were observed for either therapy.CONCLUSION: Both DL and IPL treatment is highly effective, long-lasting and safe. DL was found to be more effective than IPL treatment. DL treatment was more painful but less time-consuming than IPL therapy.

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2012Low-Fluence VS. Standard Fluence Hair Removal: A Contra-lateral Control Non-Inferiority Study

Shlomit Halachmi & Moshe Lapidoth

• Patients treated withhs handpiece were 82% more likely to seek additional treatment with hs handpiece• After 5 treatments minimalto no difference were visible between ET and hs handpieces• 83% would continuetreatment with other body areas after using HS and ET handpieces

Journal of Cosmetic and Laser Therapy, 2012; 14: 2–6

INTRODUCTION: Laser hair removal at lower fluences, delivered under certain conditions, may retain the efficacy of high-fluence lasers while improving tolerability. We performed a pilot study comparing the efficacy, safety and tolerability of laser hair removal using traditional settings compared to lower fluences, delivered from a larger handpiece and under vacuum. MATERIAL AND METHODS: Fourteen healthy participants underwent 5 axillary hair removal treatments with an 800 nm diode laser at 1-month intervals, with follow-up 1 and 3 months after the 5th treatment. In all patients, one side was treated with standard parameters using a 9 x 9 mm chilled tip and gel, while the contralateral side was treated using a 22 x 35 mm vacuum-assisted handpiece at fluences up to 12 J/cm2. Follow-up assessments were performed after each treatment and at each follow-up visit, and included photography and questionnaires. RESULTS: Eleven participants completed the study and follow-up. All experienced significant hair removal in all treated areas. At the 3-month follow-up visit, the high-fluence and low-fluence treated axillae demonstrated comparable hair reduction. Participants found the lower fluence treatments to be more tolerable. No adverse events were reported. CONCLUSION: Lower fluence diode laser, delivered under conditions of vacuum and using larger spot sizes, can provide significant hair reduction.

HS and ET deliver simi-lar effective results

Peer reviewed article

Long term clinical evaluation of LightSheer® Duet with HS hand-piece15 month follow up for treat-ment with LightSheer® Duet

2012Long-Term Clinical Evaluation of a 800-nm Long-Pulsed Diode La-ser with a Large Spot Size and Vacuum-Assisted Suction for Hair Removal

Omar A. Ibrahimi, MD, PHD, and Suzanne L. Kilmer, MD

• HS is safe and effective-15 month follow up• Significant changes inhair thickness and color• 40% patients reporting0-2 pain level duringtreatment

Dermatol Surg 2012;1–6

BACKGROUND: The long-pulsed diode (800–810-nm) laser is one of the most commonly used and effec- tive lasers for hair removal. Limitations of currently available devices include a small treatment spot size, treatment-associated pain, and the need for skin cooling.OBJECTIVE: To evaluate the long-term hair reduction capabilities of a long-pulsed diode laser with a large spot size and vacuum assisted suction.METHODS: Thirty-five subjects were enrolled in a prospective, self-controlled, single-center study of axillary hair removal. The study consisted of three treatments using a long-pulsed diode laser with a large spot size and vacuum-assisted suction at 4- to 6-week intervals with follow-up visits 6 and 15 months after the last treatment. Hair clearance was quantified using macro hair-count photographs taken at baseline and at 6- and 15-month follow-up visits. Changes in hair thickness and color, levels of treatment-associated pain, and adverse events were additional study endpoints.RESULTS: There was statistically significant hair clearance at the 6 (54%) and 15-month (42%) follow-up visits. Remaining hairs were thinner and lighter atthe 15-month follow-up visit, and the majority of subjects reported feeling up to mild to moderate pain during treatment without the use of pretreatment anes- thesia or skin cooling.CONCLUSION: A long-pulsed diode laser with a large spot size and vacuum-assisted suction is safe and effective for long-term hair removal. This is the largest prospective study to evaluate long-term hair removal and the first to quantify decreases in hair thickness and darkness with treatment.

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Laser Hair Removal

• Funda-mentals of hair • 2-patientsselection• Principles oflaser safety• Introduction• Laser tissueinteraction

Omar A. Ibrahimi Mathew M. Avram,C. WilliamHanke,Suzanne L. Kilmer& R. Rox Anderson

Guidelines for safe and effec-tive laser treatments

Dermatologic Therapy, Vol. 24, 2011, 94–107

2011 The extended theory of selective photothermolysis enables the laser surgeon to target and destroy hair follicles, thereby leading to hair removal. Today, laser hair removal (LHR) is the most commonly requested cosmetic procedure in the world and is routinely performed by dermatologists, other physicians, and non-physician personnel with variable efficacy. The ideal candidate for LHR is fair skinned with dark terminal hair; however, LHR can today be successfully performed in all skin types. Knowledge of hair follicle anatomy and physiology, proper patient selection and preoperative preparation, principles of laser safety, familiarity with the various laser/light devices, and a thorough understanding of laser-tissue interactions are vital to optimizing treatment efficacy while minimizing complications and side effects.

Peer reviewed article

BACKGROUND: A handpiece with a 35 × 22-mm treatment window that uses vacuum technology has been designed for the diode laser system. Vacuum suction stretches the skin and brings the hair follicle closer to the surface with the intent to damage the hair follicle at a lower surface fluence. The objective of this study was to compare the degree of follicular thermal damage between the sapphire-cooled smaller handpiece at a higher fluence versus the larger vacuum-assisted handpiece at a lower fluence.METHODS: Five male patients with Fitzpatrick skin types I-IV were enrolled in the study. Three test spots on the right back were treated with the vacuum-assisted laser handpiece at a setting of 10-12 J/cm², and 61-ms pulse duration. Three test spots on the left back were treated with the sapphire-cooled handpiece with a setting of 30-34 J/cm² and a pulse duration of 14-16 ms. A punch biopsy was obtained from one treated area for each handpiece type. The biopsies were sectioned horizontally and examined for the degree of thermal damage to the hair follicle at the level of the isthmus and the bulb. Immediate treatment response, pain score, and total treatment time were recorded.RESULTS: Biopsies from the skin treated with the sapphire-cooled handpiece and the vacuum-assisted handpiece showed the mean hair follicle diameter was 258.3 µm (SE [standard error] 41.7) and 225.1 µm (SE 17.1), respectively. The mean thermal damage diameter to hair diameter ratio was 0.91 (SE 0.10) and 0.72 (SE 0.12), respectively. The mean immediate treatment response, the mean pain severity, and the mean total treatment time were all lower for the vacuum-assisted handpiece. CONCLUSION: Treatment with the vacuum-assisted handpiece is faster and has a tendency to be more comfortable. Thermal damage to the hair follicle was greater with the sapphire-cooled handpiece.

Compari-son of HS and ET handpieces using duet system

Evaluation of the Vacuum-Assisted Handpiece Compared with the Sapphire-Cooled Handpiece of the 800-nm Diode Laser System for the Use of Hair Removal and Reduction

Yang Xia, Rachael Moore, Sunghun Cho, & Edward V. Ross

• Treatment with vacuumassisted handpieces is faster and more comfortable• Thermal damage to thehair follicle is greater with sapphire cooled handpieces• Measurement using biop-sies from the skin proved the thermal damage to the hair follicle while using HS and ET handpieces

J Cosmet Laser Ther. 2010 Dec;12(6):264-8

2010

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6 2008 Peer reviewed article

Diode vs IPL, Effica-cy for hair removal is higher with diode laser

Within-Patient Right-Left Blinded Comp-arison of Diode (810 nm) Laser Therapy and Intense Pulsed Light Therapy for Hair Removal

H. Cameron& S. H. Ibbotson & R. S. Dawe & J.Ferguson & H. Moseley

• Hair reduction with diodelaser is more effective than using IPL• 6 weeks after 3 treatmentsdespite slightly higher pain course, laser was preferred by more than 50% of the patients

Lasers Med Sci (2008) 23:393–397

BACKGROUND: Excessive facial hair in women can cause significant psychological distress. A variety of treatment methods are available, including lasers and, more recently, intense pulsed light (IPL) sources. There are very few studies comparing laser and IPL devices. PURPOSE AND METHODS: The purpose of our study was to compare a laser diode device with an IPL, using a within-patient, right-left, assessor-blinded, controlled, study design. Hair counts were made, using coded close-up photographs. Treatments were carried out on three occasions at 6-week intervals, and a final assessment was made 6 weeks following the thirdtreatment. Patient self- assessment was also included. RESULTS: Nine women were recruited, and seven completed the study. Average hair counts in a 16 cm2 area before and after treatment were, respectively, 42.4 and 10.4 (laser), 38.1 and 20.4 (IPL), 45.3 and 44.7 (control). Both laser and IPL reduced the hair count substantially; laser vs control was significant at P=0.028, but IPL vs control had P=0.13, suggesting that more subjects or more treatments were required if statistical significance were to be achieved. Despite subjecting the patients to higher pain scores and more inflammation, laser was preferred by five patients; two preferred IPL and one had no preference.

Peer reviewed article

7 Market review

2007Lasers and Light Sources For the Removal of Unwanted Hair

Michael H. Gold, MD

Not applicable Clinics in Dermatology 25, 443–453

The long-term removal of unwanted hair has become one of the most common and popular cosmetic laser treatments being performed around the world. This manuscript will review a variety of lasers and light sources that have been and are currently being used for epilation of the skin. All of the lasers and light systems currently available do work for long-term hair removal; it is the responsibility of the treating clinician to understand the varying technologies and what the limits of each device is and, most importantly, to be able to handle any untoward effects that might arise during the coarse of treatment. Then, hair removal can be successful for both the patient and the physician using their particular medical device.

Pain Inhibition with Pneumatic Skin Flattening (PSF) in Permanent Diode Laser Hair Removal

Malcolm KE • HGH seed techconsiderably removedthe pain in hair removalcompared with non highspeed tech• Energy density may beincreased while using HS technology to increase efficacy

Journal of Cosmetic and Laser Therapy9: 210–212

INTRODUCTION: Permanent laser-based hair removal is normally associated with acute pain. Pneumatic skin flattening (PSF) is a new technology which activates tactile and pressure skin receptors to naturally block the transmission of pain to the brain during laser-based aesthetic treatments (gate theory of pain control). OBJECTIVE: Efficacy and pain reduction was evaluated compared with controls for the treatment of hair removal with PSF and a high-energy diode laser (LightSheer®, Lumenis). METHODS: Ten patients were treated for hair removal with the LightSheer® at energy densities of 26–30 J/cm2. Each patient was treated with PSF and without PSF (control sites). Pain was evaluated on a 1–10 scale level. Hair growth was compared 1 month following treatment. RESULTS: Pain reduction was achieved with the PSF chamber in 9/10 patients. Hair removal efficacy was preserved. CONCLUSION: The PSF technology considerably reduces pain in hair removal with high-power diode lasers. Treatment efficacy is preserved with identical energy densities. Moreover, energy density may be increased without pain or side effects, resulting in the potential to enhance efficacy. Analgesic creams are no longer required.

Peer reviewed article

8 Compari-son of pain level with and without high speed technology

2007

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9 Market Review (Compari-son of ruby Nd:YAG alexandrite lasers

2004Biological and Clinical Aspects in Laser Hair Removal

J Lepselter and M Elman

Not applicable (J Dermatol Treat (2004) 15: 72–83)

INTRODUCTION: In the past century, unwanted hair has been traditionally treated with multitudes of techniques that were found to be slow, tedious, painful, impractical, and resulted in poor long-term efficacy. Consequently, there has been a public demand for a novel, rapid, reliable, safe, and affordable hair removal technique. In the last decade, laser and light-based technology for hair removal became one of the fastest growing procedures in modern cosmetic dermatology. OBJECTIVE: To discuss the latest scientific and clinical issues in the field of photoepilation as evolved in the past decade: hair biology, laser physics and skin optics, technology and clinical experience. RESULTS: From substantial clinical experience, it becomes apparent that in the ideal subject with fair skin and dark hair, a single treatment can reduce hair by 10–40%; three treatments by 30–70%; and repeated treatments by as much as 90%. These results persist for as long as 12 months. Diffuse and perifollicular cutaneous erythema and pigmentary changes are the most common adverse side effects. Most complications are generally temporary.CONCLUSIONS: Photoepilation, when properly used, offers clear advantages when compared with older, traditional techniques. Although an ever-increasing number of published studies have confirmed the safety and short and long-term efficacy of photoepilation, the technology still has limits and risks.

10 Peer reviewed article

Safety and efficacy of LightSheer® in 10 pa-tients (with skin types III to IV

2002Safe and Effective Long-Term Hair Reduction in Tanned Patients Using an 800 nm Diode Laser

Valeria B. Campos, MD

• Proven efficacy ofLightSheer® in tanned patients at specific settings• Proper settings of ET is 30J/cm2 and 100 ms

Lumenis Inc. This study examined hair reduction in eleven tanned women and one tanned man (with Fitzpatrick Skin Types III to IV) using the 800 nm LightSheer® Diode Laser System at our clinic in Jundiai, Brazil. The patients were treated with fluences ranging from 30 to 45 J/cm2 at pulse durations of 30 and 100 ms and a pulse frequency of 0.5 Hz. Long-term hair reduction was achieved with all tested fluences and pulse durations, with hair regrowth ranging from 23% at one month post-treatment to 73% at the twelve-month follow-up period. Although the difference was not statistically significant, hair regrowth was slightly higher in sites treated at 100 ms at all time periods. With a fluence of 30 J/cm2 and a pulse duration of 30 ms, a single treatment site on each of three patients developed either hypopigmentation (1 site) or hyperpigmentation (2 sites). At 30 J/cm2 and 100 ms, no pigmentary change or any other sign of epidermal injury was observed in any patient treated. This study suggests that the LightSheer® Diode Laser System provides both safe and effective long-term reduction of unwanted hair in tanned patients with a fluence of 30 J/cm2 and a pulse width of 100 ms.

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11 Contact cooling efficacy and safety for hair removal (et Chill Tip hand piece)

Peer reviewed article

2002 BACKGROUND AND OBJECTIVES: Sapphire contact cooling is widely used to prevent non-specific epidermal injury from occurring during selective laser treatment of unwanted hair and vascular lesions. This small study was performed to examine the clinical response of the skin to 800-nm laser irradiation with varying extent of cutaneous sapphire contact cooling. Observed clinical responses are compared to those predicted by theoretical analysis in an attempt to construct a more complete picture of sapphire contact cooling and its role in preventing non-targeted tissue devitalization during laser treatment of the skin using a wavelength, pulse duration, and radiant exposure commonly used for laser hair removal.STUDY DESIGN/MATERIALS AND METHODS: Three subjects each received a total of three pulses of laser light (800 nm) of equal radiant exposure (60 J/cm(2)), pulse duration (30 msec), and spot size (9 mm x 9 mm), but with varying extent of cutaneous cooling. One site was pre-cooled and heat-sinked with a chilled (5 degrees C) sapphire window in contact with the skin; another site was heat-sinked only with a room-temperature (20 degrees C) sapphire window in contact with the skin; and a third site received no pre-cooling or heat-sinking. Each site was examined immediately after treatment and at intervals throughout a 3-month period. The thermal response of the tissue was calculated in each case using a Monte Carlo model for light transport in multi-layered tissues coupled with an axisymmetric finite-difference heat diffusion model. Thermal injury was modeled as a first-order kinetic rate process using an Arrhenius expression.RESULTS: In all three subjects, the sites that were pre-cooled and heat-sinked showed no evidence of epidermal or dermal devitalization. The three sites that were heat-sinked only had a few patches of perifollicular epidermal devitalization and subsequent desquamation without any permanent epidermal or dermal injury, as would be evidenced by pigmentary alteration or textural change. In each subject, the site that received no pre-cooling or heat-sinking sustained epidermal and dermal devitalization, appearing as ulceration and resulting in sustained erythema and textural alteration. Clinical responses predicted by theoretical analysis agree with the clinical observations and show that the dominant effect of sapphire contact cooling for pulse durations of 30 msec or less is the reduction of fluence within the epidermis resulting from index matching at the skin surface.CONCLUSIONS: The results of this small study suggest that by judiciously selecting the laser pulse duration and pre-cooling and heat-sinking the epidermis in a manner that provides index matching and compression of the skin, epidermal damage can be avoided while administering the highest, most effective radiant exposures.

Importance of Cutaneous Cooling During Photo-thermal Epilation: Theoretical and Practical Con-siderations

Kurt G. Klavuhn, PhD, and David Green, MD

Treatment using Chill Tip with high fluence did not have any permanent damage to epidermis or dermal injury

Lasers Surg Med. 2002;31(2):97-105.

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BACKGROUND: Laser hair removal is becoming an increasingly popular alternative to traditional methods such as shaving, waxing, depilatory creams, or electrolysis. Numerous laser systems are currently available offering different methods of illuminating the treatment area. The fluence distribution within the tissue and, thus, the treatment efficacy depends upon the illumination geometry, namely the index matching at the skin surface, the incident spot size, and the energy distribution within the incident beam. OBJECTIVE: To analyze and discuss the various aspects of illumination geometry in the context of laser hair removal. METHODS: Detailed calculations of the influence of each aspect on the energy distribution during the treatment pulse were performed. CONCLUSION: Calculations using typical skin parameters for wavelengths of 650–1100nm show that matching of the index of refraction at the skin surface by illumination of the treatment area through sapphire in contact with the skin, for example, alone (i.e. aside from the beneficial heat-sinking effects) can reduce the epidermal heating up to 30% by minimizing the amount of internally reflected photons at the skin surface. Thus, by providing favorable index matching at the skin surface, sapphire contact enables the safe use of higher, more effective fluence levels.The calculations also show that a 10-mm diameter spot size (or 9-mm square) produces a fluence level at target depths of 1–3mm equal to 73–88% (depending on depth) of the fluence level at the same depths produced by an infinitely wide beam of equal incident fluence. This means that little additional penetration is achieved with larger spot sizes. In addition, most commercial laser hair removal systems that provide larger spot sizes (> 14 mm in diameter) are unable to produce adequate fluence at the larger beam sizes to achieve the same level of efficacy of systems with 8–14mm diameter beams. In contrast, a 5-mm diameter spot size produces a fluence level at target depths of 1–3mm of only 37–52% (depending on depth) that of an infinitely wide beam of equal incident fluence. Because of the epidermal heating resulting from the rela- tively high fluence level at the skin surface, the penetration of smaller diameter beams can not be made to match that of broader beams by simply increasing the incident fluence. Thus, laser hair removal systems that provide smaller spot sizes (< 8 mm in diameter) may be unable to safely produce the desired therapeutic effect.Calculations using typical skin parameters for wavelengths of 650–1100nm show that, for equivalent epidermal heating, up to 54% higher fluence can be applied using a beam with a flat energy distribution profile versus a Gaussian profile, resulting in significantly deeper and broader penetration of the beam. For this reason, a laser hair removal systems with a predominantly flat beam profile will be more effective and induce fewer complications than a laser with a largely Gaussian profile (i.e. with a central “hot spot”).

Peer reviewed article

12 Comparison of Large spot size vs. Small spot size

2001Illumination Geometry: The Importance of Laser Beam Spatial Character-istics

Kurt G. Klavuhn, PhD

• 9mm square spot sizeprovide the most effective target depth (1-3mm) and fluence• Sapphire contact enablesthe safe use of higher more effective fluence levels• Spot size smaller than8mm may be unsafe• Spot sizes higher than9mm will have less fluence per square cm• Beam profile is veryimportant as flat beam has 54% more fluence than a Gaussian beam

Lumenis, Inc.

Laser hair removal has made possible the permanent reduction of unwanted hair. However, this technology remains far from perfect. Many advances have occurred in the past several years to improve laser hair removal, including lengthening pulse widths and adding mechanisms to cool the skin during treatment. These advances have improved results and broadened the scope of patients who are candidates for this procedure. This article reviews the latest advances as well as the various laser hair removal systems currently available.

Peer reviewed article

13 Market overview

2001Laser hair removal update

Mark M Hamilton, M.D., StevenH. Dayan,M.D., Paul J.Carniol, M.D., F.A.C.S.

Facial Plast Surg. 2001 Aug;17(3):219-22.

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14 Advantages of using large spot size vs using small spot size

2001 BACKGROUND: Laser hair removal is becoming an increasingly popular alternative to traditional methods such as shaving, waxing, depilatory creams, or electrolysis. Numerous laser systems are currently available offering different maximum fluence levels, spot sizes, and pulse repetition frequencies, each of which influence the amount of time it takes to treat a given area.OBJECTIVE: To analyze and discuss the influence of various laser parameters on coverage rate. METHODS: The influence of various laser parameters, including spot size and shape, and repetition frequency, on coverage rate and their impact on available fluence and pulse duration were analyzed. Theoretical coverage rates for commercially available hair removal systems were calculated and compared. CONCLUSION: For laser hair removal systems with square, rectangular, or hexagonal beam shapes, the coverage rate is equal to the area of the treatment spot times the pulse repetition frequency. Treatment with a circular beam requires a minimum of 17% overlap in order to cover the entire treatment area. In general, large spot sizes (i.e. > 14 mm in diameter) enable more area to be treated with each laser pulse; however, at least 25–30 J/cm2

at 755–800 nm (80–100 J/cm2 at 1064nm) must be available to effect clinically significant long- term hair reduction. Treatment with small spot sizes (i.e. < 8 mm in diameter) may result in inadvertent “missed” areas as a result of the reduced penetration of the beam. Scanning systems without contact cooling are limited in the amount of fluence that can be used as a result of increased risk of epidermal injury. All Lumenis LightSheer® Diode Laser Systems are effective at the appropriate treatment fluences. The LightSheer® ET has a faster coverage rate (up to 1.5–2 times) than all major hair removal systems at fluences of 25J/cm2 and higher. The new Coherent LightSheer® XC Diode Laser System with a 12 × 12-mm beam and repetition rates up to 2 Hz provides the fastest coverage rate of all commercially available hair removal systems.

Coverage Rate: The Influence of Laser Para-meters on Treatment Time

Kurt G. Klavuhn, PhD

• Large spot size enablesbigger area to be treated with each pulse• Small spot size mightleave missed areas

Lumenis, Inc.

Peer reviewed article

15 Market review

2000Hair Removal by Lasers and Intense Pulsed Light Sources

Christine C. Dierickx, MD

Semin Cutan Med Surg. 2000 Dec;19(4):267-75.

Unwanted pigmented hair is a common problem for many patients. Traditional methods of hair removal have included shaving, bleaching, plucking, waxing, use of chemical depilatories, and electrolysis. These techniques have been limited by their pain, inconvenience, and poor long-term efficacy. Only electrolysis has offered the potential for permanent hair removal. However, the technique is tedious, highly operator-dependent, and impractical for the treatment of large numbers of hairs. Recently, a number of lasers and other light sources have been developed specifically to target hair follicles. These include ruby, alexandrite, diode, and Nd:YAG lasers and an intense pulsed light source. These devices offer the potential for rapid treatment of large areas and long-lasting hair removal. This article explains the mechanisms of using light to remove hair, examines the attributes of specific laser systems, and explains the importance of patient selection and treatment protocol for the various systems in order to provide a safe and effective treatment.

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BACKGROUND AND OBJECTIVE: Laser hair removal is a relatively new procedure. Our purpose was to study the efficacy and safety of a high-power, pulsed diode laser array for removing unwanted hair.METHODS: A total of 38 subjects were treated with a prototype of the 800-nm diode laser system. Fluences ranging from 10 to 40 J/cm(2) (mean,33.4 J/cm(2)) were used and 1 to 4 treatments (mean, 2.7) were performed. Evaluation of hair loss was performed at least 4 months after the last treatment (mean, 8.7 months) by a blinded assessment of clinical photographs.RESULTS: A total of 59% of the subjects had only sparse hair regrowth at the final follow-up. Higher fluences and multiple treatments produced greater long-term efficacy. Transient pigmentary changes occurred in 29% of the subjects and were more common in darker skin types IV to VI (P =. 047).CONCLUSION: The 800-nm diode laser is an efficient and safe technique for hair reduction. Adverse pigmentary effects occur, but are transient.

Peer reviewed article

16 800 nm diode laser is effective and safe for hair removal

2000Hair removal with an 800-nmpulsed diode laser

Valeria B. Campos MD, Christine C. Dierickx,MD, William A. Farinelli,BS, Tai-Yuan D. Lin, MD,Woraphong Manuskiatti, MD, and R. RoxAnderson, MD

Higher fluences and multiple treatments produce long term efficacy

J Am Acad Dermatol. 2000 Sep;43(3):442-7

BACKGROUND: Multiple laser systems are available for the purpose of hair removal.OBJECTIVE: The purpose of this study was to determine the safety and long-term efficacy of the 800 nm, pulsed diode laser at reducing hair count.METHODS: Fifty volunteers, primarily Fitzpatrick skin types II and III, with dark brown or black hair, were treated with a diode laser (800 nm, 10-40 J/cm2, 5-30 msec, 9 mm 9 mm, 5 degrees C chilled handpiece). Each subject had eight treatment sites at varying fluences and pulse durations, as well as a varying number of treatments and pulses. Hair counts were obtained at each site at baseline, 1, 3, 6, 9, and an average of 20 months after treatment.RESULTS: After one treatment, hair regrowths ranged from 22 to 31% at the 1-month follow-up visit, then remained stable between 65 and 75% from the3-month to the averaged 20-month follow-up. After two treatments there wererelatively longer growth delays, with hair regrowths plateauing beginning at 6 months after treatment and ranging from 47 to 66% for the remainder of the follow-up evaluations. Side effects were limited to pigmentary changes, transient in subjects with skin types II and III.CONCLUSIONS: This 800 nm diode laser with a chilled sapphire tip and variable pulse duration is safe and effective for long-term hair reduction in individuals with skin types II and III.

Peer reviewed article

17 800 nm diode laser chill tip cooled provides long-lasting results in patients

2000Prospective study of hair reduction by diode laser (800 nm) with long-term follow-up

Wendy W. Lou, MD, Adelle T. Quintata1, MD, Roy G. Geronemus, MD, and Melanie C. Grossman, MD

• 50 patient 8 tested sites20 month follow up shows permanent hair loss of 65-75%• 800 nm laser diode is safeand effective with variable pulse duration

Dermatol Surg. 2000 May;26(5):428-32

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Laser pulses which selectively damage pigmented hair follicles are a useful treatment for hypertrichosis. Clinically, regrowing hairs are often thinner and lighter after treatment. In this study, hair shaft diameter and optical transmission (700 nm) were measured before and after ruby (694 nm) and diode (800 nm) laser irradiation. Hair was collected from 47 and 41 subjects treated with ruby (0.3 ms and 3 ms) and diode (10-20 ms) lasers, respectively. “Responders” were defined as subjects with significant long-term hair loss as determined by hair counts at 9 and/or 12 months after treatment. In ruby laser responders (34/47), regrowing hairs were significantly both thinner (decreased diameter) and lighter (increased transmission). In “nonresponders” (13/47), regrowing hairs were lighter, but not thinner. The regrowing hair shaft absorption coefficient (as calculated assuming Beer’s law) was significantly decreased by 0.3 ms ruby laser treatment, but was not changed by 3 ms ruby laser or diode laser treatment. After diode laser treatment, 38 of the 41 subjects were responders and regrowing hairs were both thinner and lighter. These results show that laser treatments can affect structural recovery (size of hair), follicular pigmentation (hair absorption coefficient), or both. Regrowth of thinner hair (decreased shaft diameter) occurs in conjunction with actual loss of hair. After long pulses (3 ms ruby; diode), regrowing hair was thinner and also lighter to an extent related to the decrease in hair diameter. In contrast, short ruby laser pulses (0.3 ms) appeared to be capable of inhibiting follicular pigmentation per se, in addition to affecting the hair diameter. This may account for the complete regrowth of lighter hair in “nonresponders” treated with 0.3 ms pulses. Laser-induced reduction in hair diameter and/or pigmentation are both long-term responses which confer cosmetic benefits in addition to actual hair loss.

Peer reviewed article

18 Diode laser is more effec-tive than ruby

2000Reduction of Regrowing Hair Shaft Size and Pigment-ation After Ruby and Diode Laser Treatment

Tai-Yuan David Lin, Christine C. Dierickx,Valeria B. Campos, William A. Farinelli, Joshua Rosenthal, R. Rox Anderson

• With ruby laser 85%responded to treatment, with diode laser 92% responded to treatment• With diode laser the resultsalways show thinner and lighter hair, whereas with ruby laser the results dont always show

Archives for Dermatological Research (Impact Factor: 2.71). 01/2000; 292(2-3):60-7

BACKGROUND: Pilonidal sinus disease is a debilitating, disfiguring chronic ailment that is often resistant to therapy. Its etiology and treatment remain in question.OBJECTIVE: To assess the efficacy of an 800 nm diode laser in the treatment of recalcitrant pilonidal sinus disease.METHODS: Two patients with recalcitrant pilonidal sinus disease were treated in the lower back, buttocks, and perigluteal cleft area with an 800 nm diode laser with a spot size of 9 x 9 mm, fluences of 30 to 48 J/cm2, and pulse widths of 15 to 24 milliseconds.RESULTS: Long-term relief of pilonidal sinus disease was produced with as few as two treatments 2 months apart to as many as six treatments over a 2-year period. With each successive treatment, fewer pulses were needed andthe interval between treatments increased.CONCLUSION: The 800 nm diode laser may be an effective tool in the treatment of pilonidal sinus disease. By eliminating the source of hair and hair fragments that course along the surface of the lower back and buttocks, interruption of the etiologic source for pilonidal sinus disease can be accomplished.

Pilonidal Sinus Disease Treated by Depilation Using an 800 nm Diode Laser and Review of the Literature

Anthony V. Benedetto, DO, FACP, Alan T. Lewis, MD

The 800 nm diode laser may be an effective tool in the treatment of pilonidal sinus disease

Dermatol Surg. 2005 May;31(5):587-91.

Peer reviewed article

19 Diode laser is effective in the treat-ment of pilo-nidal sinus disease

2005

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Acne keloidalis nuchae is usually treated with oral antibiotics, local antiseptics or intralesional steroids but with limited success. I assessed the efficacy of diode laser for treating the inflammatory and keloidal papules of acne keloidalis nuchae in two cases. The lesions in both the cases showed about 90 to 95% clearance after 4 treatment sessions at one to one and half month intervals. No new lesions were observed during the follow up period of six months after the last laser treatment. Thus, after clearing bacterial infection, laser hair epilation can be used as the first line of therapy for treating papules of acne keloidalis nuchae. This is the first attempt at treating acne keloidalis nuchae with a diode laser.

Efficacy of Diode Laser for Treating Acne Keloidalis Nuchae

Girish K. Shah

• 90-95% clearence of acneafter only 4 treatments with diode laser• Laser diode treatmentprevented reccuring of the acne

Indian J Dermatol Venereol Leprol. 2005 Jan-Feb;71(1):31-4.

Peer reviewed article

20 Succesful treatment of Acne Keloi-dalis Nuchae with Diode lasers

2005

White paper

Laser Hair Removal: Efficiency, Efficacy, and Com-fort Are Key

LightSheer® Duet

Girish (Gilly) Munavalli, MD

• LightSheer® Duet : thepower of two easily inter-changeable handpieces for various anatomic sites and fast hair removal• Patient selection andmanagement are key for suc-cesful hair removal

Lumenis Supplement to Practical Dermatology

Laser hair removal is one of the top three most popular aesthetic services requested by patients in the US, and is also among the highest-reimbursed procedures.Many established and growing dermatology practices may find that laser hair removal is an attractive addition to their service menu. Of course, due to patient considerations, laser hair removal is not a good fit for every practice (see the side- bar for some important considerations). Yet, some practices that would likely benefit from the inclusion of laser hair removal have been reluctant to embrace the service due to perceived limitations of the laser systems themselves. The LightSheer® Duet system (Lumenis) is a two-in-one system that has streamlined laser hair removal treatment in my practice and allows for a patient-friendly, practice-enhancing experience.

White paper

Optimizing the Ef-ficacy and Comfort of Laser Hair Removal Treatment

2013• Comparisonof LS Desirewith palomarvectus• Articlesreview• See alsohttps://www.youtube.com/watch?v=eD8VnSuKu88

Mary P Lupo MD

• Compared to PalomarVectus:1. LS Desire has 40 %shorter treatment time.2. LS Desire is more than40% less painful.3. Efficacy of Vectus isquestionable ((Lowery et al.), Efficacy of LS desire is proven throughout this Compendium.• Compared to other sytems(ND:YAG) LS Desire is shorter less painful and has an Efficacy that is as good as other technologies.

Lumenis, Inc INTRODUCTION: Physicians who wish to maintain or increase their share of the laser hair removal market must find ways to differentiate themselves from competitors and to offer a treatment that is optimized for efficacy and comfort. While a practitioner’s skill and expertise play a large role in the treatment experience, the choice of laser hair removal system also has significant impact on patient satisfaction in both the near and longer term. Data indicate that the two LHR areas with which physicians are most concerned are patient pain and efficacy.METHOD: Here we compare the data describing the efficacy, pain, and treatment time for the LightSheer® DESIRETM (Lumenis®, Inc.) and Vectus TM (Palomar Medical Technologies, Inc.).CONCLUSIONS: 1.mean Treatment time in various areas is:6 minutes with LS Desire- and 9.6 minutes with Palomar Vectus (on 15 patients)2. Pain: Average VAS scores were significantly lower for the LSHS (2.2 ± 0.5)than for the Vectus large spot size (3.9 ± 0.5) (p < .01)

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24 Safety and efficacy of women II to VI

2002Atif Kazmi, MD

Reduction of 70-85% of hair within 4-5 treatments

Lumenis Inc. This retrospective study examined hair removal using the LightSheer® Diode Laser System for the first 1000 women (with Fitzpatrick Skin Types II to VI) treated at the Laserex Skin & Cosmology Clinic in Lahore, Pakistan. Overall, the women achieved satisfactory results within four or five treatment sessions, with apparent hair reduction ranging from 70% to 80% in women treated over their entire face and neck, up to 95% in women treated for hair on their legs, arms, or bikini line. Minor scabbing or pigmentation changes were observed in a small percentage of women treated, but these adverse effects were transient in nature and resolved after treatment was stopped. This study demonstrates that the LightSheer® Diode Laser System provides both safe and effective removal of unwanted hair in patients with Fitzpatrick Skin Types II to VI.

White Paper

25 Safety and efficacy of dialed laser treatments

2002Effective, Perma-nent Hair Reduction Using a Pulsed, High-Power Diode Laser

Christine C. Dierickx,MD; R. Rox Anderson, MD; Valeria B. Campos,MD; Melanie C. Grossman,MD

Effective laser fluence in various treatment numbers and various pulses numbers

Lumenis Inc. A solid-state, 800 nm pulsed near-infrared diode laser1 was studied for permanent hair reduction. The effect of laser fluence (energy per unit area), single vs. multiple treatments, and single vs. multiple pulses were determined in different skin types (Fitzpatrick’s type I through VI).

Laser Hair Removal with an 800nm Diode Laser - A Retro-spective Study of 1000 Women with Skin Types II to VI

White Paper

2013Comparison of Candela GentleLase to LS Duet

Doris Day, MD

Candela Gentelase is inferior to LS duet in parameters of: pain, treatment time, and profitability

Lumenis, Inc INTRODUCTION: The Market. Laser hair removal is one of the top five nonsurgical cosmetic procedures in the United States, with over 1.2 million procedures performed in 2012. It can appear that there is a dermatologists’ office on every corner offering this service, however, from 1997 to 2012 there was almost a 500% increase in the total number of minimally-invasive procedures such as injectable and laser procedures, and permanent hair removal still has the potential to be very profitableMETHOD: LS Duet and Candela GentleLase: Comparison of earning per patient. Comparison of treatment time.CONCLUSIONS: Treatment time with GentleLase is about 4 times longer than with LS Duet. Earning per patient is almost twice for LS Duet then with the GentleLase. Patient comfort is better due to the uneccesity of gel for treatment with HIT technology. 87% of patients describe the treatment with HIT as “virtually painless.”

Optimizing Earnings withLaser Hair Removal

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26 LightSheer® dialed laser permanent hair reduc-tion

2002Laser Hair Removal: Scientific principles and Practical Aspects

Christine C. Dierickx, M.D.

• 89% permanent hairreduction in patients• Hair reduction is a functionof the fluence properties• Laser energy ommitiondoes not damage epidermis

Lumenis Inc. The use of lasers for hair removal has been studied for a number of years. In this procedure, laser light is absorbed by melanin in the hair shaft, damaging the follicular epithelium. A clinical study evaluated the use of the LightSheer®

Diode Laser for hair removal. Of 92 patients, all had temporary hair loss and 89% had permanent hair reduction. Regrowing hairs were shown to be thinner and lighter than previously. Extensive clinical use of this high-power, pulsed diode laser has resulted in recommendations for patient selection and proper use of the laser. Appropriate fluence settings have been shown to cause permanent hair reduction without damaging the epidermis, regardless of skin type.

BACKGROUND: Laser hair removal is becoming an increasingly popular alternative to traditional methods such as shaving, waxing, depilatory creams, or electrolysis. Numerous laser systems are currently available offering different methods for protecting the epidermis from thermal injury during treat- ment.OBJECTIVE: To analyze the effectiveness of sapphire contact and cryogen spray cooling in the context of laser hair removal. METHODS: A detailed analysis of each technique including calculations of the skin’s thermal response to each cooling method before, during, and after the treatment pulse was per- formed.CONCLUSION: Sapphire contact cooling is significantly more effective than cryogen spray cooling in protecting the epidermis from unwanted thermal damage during laser hair removal treatment. Calculations show that a system using sapphire contact cooling with a 30ms pulse duration is approximately two times more effective in protecting the epidermis than cryogen cooling with 3ms pulses given equal target heating. Efficient precooling of the epidermis, compression of the skin, and concurrent heat-sinking of the epidermis with a chilled sapphire window in conjunction with a longer treatment pulse duration result in superior epidermal protection. The concurrent heat-sinking of the epidermis in conjunction with a longer treatment pulse duration is the largest contributing factor reducing the temperature rise of the epidermis by over 40%. In addition to being more effective, sapphire contact cooling provides protection of the epidermis at significantly lower cost, with no risk of freezing and maximum comfort for the patient by cooling before, during, and after the treatment pulse.

White Paper

27 Sapphire contact cooling (Chill Tip) is significantly more effec-tive than cryogen spray cool-ing

2001Epidermal Protection: A Comp-arative Analysis of Sapphire Contact and Cryogen Spray Cooling

Kurt G. Klavuhn, PhD

• Sapphire cooling isprotecting the epidermis from damage• The efficacy for the contactcooling is twice of the cryogen cooling• Sapphire contact coolingprovides maximum comfort for patients

Lumenis, Inc.

White Paper

28 Wide range study of LightSheer® on variety of patients shows both safety and efficacy

2001Use of the LightSheer® Diode Laser System for Hair Reduction: Safety and Efficacy in a Large Series of Treatments

Rube J. Pardo, MD, Ph.D., Judy Fahey, RN

• 250 sites 144 patientsskin types II-V 84% showed good to excellent results• More than 96% weresatisfied with the treatment

Lumenis Inc. An 800 nm high-power, long-pulsed diode laser with contact cooling provides safe and effective reduction of pigmented hair in patients with a variety of skin types. This paper presents the safety and efficacy results of 800 treatments performed on 250 sites in 144 patients with Fitzpatrick skin types II-V. Over 84% of sites showed a good or excellent response following the second and subsequent treatments. Treatment responses were similar for all skin types treated, with an excellent safety profile. Side effects were noted in only two of the 800 treatments and were transient in nature. Patients were extremely or moderately satisfied with over 96% of their treatments.

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29 Hair removal utilizing the Light-Sheer® Duet HS hand piece and the Light-Sheer® ET: A compara-tive study of two diode laser systems in Chinese women

Comparison of HS and ET in Chinese women after 3 months follow up

ZHhan-Chao Zhou, Li-Fang Guo & Michael H. Gold

• HS and ET handpieces areequivalent for hair reduction on chinese women• Treatment with Duet isconvenient and associated with less pain• Women preferred HS lasertreatment

Journal of Cosmetic and Laser Therapy, 2011; 13: 283–290

2011 OBJECTIVE: To compare the clinical efficacy, safety and pain associated with the use of the LightSheer® Duet HS as compared to the original LightSheer® ET diode Laser for axillae hair removal in Chinese women. METHODS: Thirty-six Chinese women received three axillae laser hair removal treatments using the LightSheer® Duet HS on one side and the LightSheer® ET on the other side. Subjects were evaluated for hair removal efficiency. The immediate pain associated with the treatments was noted. RESULTS: At 1 month following the final laser treatment, hair reduction on the LightSheer® Duet HS side and on the LightSheer® ET side was 81 ± 13% and 85 ± 9% respectively.There was no statistical difference. Immediate pain scores at the first session on the LightSheer® Duet HS sites and LightSheer® ET sites was 5.71 ± 1.74 and 6.86 ± 1.80 respectively, which was statistically significant (p < 0.05). Following the second and third sessions, immediate pain scores of the LightSheer® Duet HS sites were both less than those of the LightSheer® ET sites, but the differences were not statistically significant. CONCLUSIONS: The LightSheer® Duet HS laser is a safe and effective method of hair removal in Chinese women. Treatment with the LightSheer® Duet HS causes less pain.

Peer reviewed article

30 Comp-arison of Hair Removal Utilizing a Diode Laser and an Nd:YAG Laser System in Chinese Women

An Efficacy Comp-arison of Hair Removal Utilizing a Diode Laser and an Nd:YAG Laser System in Chinese Women

Ruohong Li, Zhanchao Zhou & Michael H. Gold

• Pain scores for diode la-sers are lower than Nd:YAG • Hair reduction wth diodelaser is significantly better than with Nd:YAG

J Cosmet Laser Ther. 2010 Dec;12(6):269-75

2010 BACKGROUND: The 800 nm diode laser and the 1064 nm Nd:YAG laser have been used successfully for hair removal for many years. OBJECTIVE: To compare the efficacy of a diode laser with a Nd:YAG laser regarding axillary fossa hair removal in Chinese women. METHODS: Twenty-nine Chinese women underwent three treatment sessions at 4-week intervals with a diode laser (34–38 J/cm2) on one side and a Nd:YAG laser (34–40 J/cm2) on the other side. Assessments included the reduction of hair diameter following treatment, the regrowth rate in hair length, total hair reduction and the immediate pain associated with the treatments. RESULTS: At follow-up visit number 1 (4 weeks after the first session), the average reduction in hair diameter on the diode laser side and the Nd:YAG laser side was 2.44 μm and –0.6 μm, respectively. The regrowth rates of the hair were 61.93 μm/day and 59.84 μm/day, respectively, which were not statistically significant (p > 0.05). At follow-up visit number 1, hair reduction was 60.09% and 41.44%, respectively. At follow-up visit number 2 (4 weeks after the second session), hair reduction was noted to be 78.56% and 64.50%, respectively, which were both statistically significant (p < 0.05). Immediate pain scores at the first session were 6.97 and 6.17, respectively; at the second session were 5.48 and 6.69, respectively; and at the third session were 5.76 and 7.45, respectively; all statistically significant (p < 0.05). CONCLUSIONS: The diode laser showed more efficacy and was found to be more comfortable than the Nd:YAG laser for axillary fossa hair removal in Chinese women.

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31 LightSheer® is safe and effective for Asian skin types (Japa-nese)

2000 In this retrospective study of 101 Japanese patients, we were able to achieve temporary hair removal in all patients with even single laser treatments. Longer lasting results required multiple treatments, and 50% of all patients achieved 60% or greater permanent hair reduction. Complications were mild and transient, and to maximize treatment efficacy and safety, longer pulse durations and active skin cooling are critical for darkly complected patient populations. These initial experiences with the LightSheer® system on an all-Japanese patient base demonstrated that 800 nanometer diode laser assisted hair removal can be performed as effectively and as safely on Asian populations as on Caucasian patients.

Peer reviewed article

Diode Laser-Assisted Hair Removal in Asians: A Study of 101 Japanese Patients

Taro Kono, MD and Motohiro Nozaki, MD

• LightSheer® study showspermanent hair reduction for Japanese• Active skin cooling iscritical for dark complection

Lumenis, Inc

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Advances in Laser Hair Removal in Skin of Color

Using long pulsed diode laser for HR in skin of color

Eliot F. Battle Jr. MD

• Safe treatment of skin ofcolor with long pulsed diode laser• Side effect of laser hr istreatment of pseudo-folliculitis barbae and post inflammatory dyspigmentation

J Drugs Dermatol. 2011;10(11):1235-1239.

2011 Laser hair removal, previously contraindicated in patients with ethnically dark (phototypes IV–VI) or sun-tanned skin, is now recognized as a safe and effective method of permanent hair reduction in all patients. Longer wavelengths, conservative fluences, longer pulse durations and appropriate cooling methods are necessary to minimize untoward side effects and maximize efficacy. The longer- wavelength Nd:YAG laser is considered safest in treating darker skin of color. An added benefit of laser epilation is that side effects of conventional hair removal such as pseudo-folliculitis barbae and post inflammatory dyspigmentation, more commonly seen in skin of color, may also respond favorably to the laser, thus increasing the potential for patient satisfaction

33 A doctor’s consulta-tion for dark skin treat-ment

2004Laser-Assisted Hair Removal For Darker Skin Types

Eliot F. Battle, JR. & Lori M. Hobbs

• Diode laser is the moreeffective then ND:YAG for darker skin• Conservative fluencesand longer pulse durations with multiple treatments are necessary with darker skin types.

Dermatologic Therapy, Vol. 17, 2004, 177–183

INTRODUCTION: By using conservative fluences, longer pulse durationsand multiple treatments, safe and effective laser-assisted hair removal is possible for darker skin types. Patients with darker skin who suffer from hirsutism, hypertrichosis, and pseudofolliculitis barbae can finally be treated safely and effectivelyCONSULTATION AND DISCUSSION FOR DOCTORS ON THE FOLLOWING ISSUES:• Appropriate laser systems to treat• Darker skin types safely• Appropriate laser parameters and test• Spots• Patient selection• Consultation of patients with darker• Skin types• Laser treatment• Pseudofolliculitis barbae• Laser-induced side effects• Hirsutism and hypertrichosis• Acne keloidalis nuchaeCONCLUSION: The safest and most effective hair-removal lasers to treat darker skin types are either the diode or Nd:YAG-based laser systems. Because of the longer wavelength, the Nd:YAG system is the safest, while the diode wavelength is probably more effective. Conservative fluences and longer pulse durations with multiple treatments are necessary in order to provide safe and effective treatments to patients with darker skin types.

Peer reviewed article

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35 Trichostasis spinulosa treatment with diode laser

2003 BACKGROUND: Trichostasis spinulosa (TS) is a common follicular disorder that results from the retention of multiple vellus hairs within pilosebaceous follicles. A variety of treatment modalities have been used with variable but largely transient success.OBJECTIVES: To determine whether a pulsed diode laser irradiation would provide a therapeutic response to TS for a prolonged period.METHODS: Thirteen subjects with untreated TS and skin phototypes III, IV, and V were treated with a 800-nm pulsed diode laser at fluences ranging from 24 to 40 J/cm2 (mean, 36 J/cm2) and a 12- to 20-ms (mean 18 ms) pulse width. Two treatments were delivered at 4-week intervals. Evaluation of improvement was performed at 4 and 20 weeks after the last treatment by a blinded assessment of clinical photographs.RESULTS: Complete clearing of the lesions was achieved for a period of 8 to 12 weeks. A decrease in dark-plug appearance of greater than 50% was noted in half of the subjects 20 weeks after the second treatment. No pigmentary changes and scarring occurred in any subjects.CONCLUSION: Pulsed diode laser proved to be a safe and long-term effective treatment for TS in dark-skinned individuals.

Treatment of Tricho-stasis spinulosa in skin phototypes III, IV, and V with an 800-nmpulsed diode laser

Woraphong Manuskiatti, MD, and Niyom Tantikun, MD

• Succesful treatment ofTrichostasis spinulosa (TS). with diode laser after 20 weeks follow up• Since TS is a hair disorder,using a laser for hair removal will treat TS as well

Dermatol Surg. 2003 Jan;29(1):85-8.

White Paper

34 Treatment of dark skin with 400 ms pulse dura-tions

Successful laser hair removal relies on the principle of selective photothermolysis. The preferential absorption of light energy by melanin pigment in the hair follicle occurs when appropriate wavelengths, fluences and pulse durations are chosen. In laser hair removal systems, pulse durations are typically equal to or shorter than the thermal relaxation time (TRT) of terminal hair follicles. The required pulse duration for permanent reduction of medium to coarse hairs must be longer than the TRT of the hair shaft in order to permit thermal diffusion and damage to the regenerative structures of the follicle. The challenge with laser hair reduction in dark skin individuals is to target the hair follicle while protecting the melanin-rich epidermis. This involves two techniques, the selection of extended pulse durations and the use of aggresive contact cooling. Selective photothermolysis predicts that heat diffuses more slowly from thick, coarse hairs, than from smaller structures, such as the melanin containing epidermis. Coupled with contact cooling, longer pulse durations confine thermal damage to the follicle while allowing heat to diffuse from the epidermis. Under these circumstances, the skin does not reach its damage threshold and is protected from thermal injury. Continuous contact cooling, before, during and after the pulse, lowers the epidermal temperature prior to the pulse and later, extracts heat away from the skin. This combination of skin cooling techniques and extended pulse durations permits the safe use of higher, more efficacious fluences for the treatment of dark-skinned individuals.

Evaluation of a New 400 ms Extended Pulse Light-Sheer® Diode System for Safe and Effective Laser Hair Removal

Vic A. Narurkar, MD

The addition of 400 ms pulse with expense the safety and efficacy of LightSheer® in dark skin types by requiring fewer TRT teatments for long term hair reduction

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STUDY TYPE TITLE AUTHORS RESEARCH SITES PUBLICATION YEAR LANG.TOPIC ABSTRACT

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STUDY TITLE AUTHORS MAIN ARTICLE CONCLUSIONS PUBLICATION YEAR TYPEABSTRACTMAIN TOPICS

PB

-2000876 Rev A

White Paper

36 LightSheer® Diode Laser is safe and comfortable

2002 INTRODUCTION: In current laser systems, although available fluence vary, clinically-effective lasers are capable of delivering in excess of 30-40 J/cm2. Over the past four years, we have had the opportunity to use five different systems for laser hair removal. Results of our clinical studies indicate that longer pulse durations are associated with greater efficacy and with fewerpostoperative clinical side effects such as blistering and pigment disturbances.METHOD: Over the past ten months, greater than 125 patients have received a total of one or more treatments using the LightSheer® Diode Laser system. A variety of anatomic sites were treated including lip, face, neck, axillary, bikini areas, and backs. Our protocol involved treatment with follow-up at one week and one month after each treatment. Patients were re-treated when significant regrowth had occurred, which ranged from one to three months’ time.Over 90% of patients had two treatments and over 70% had three treatments.Figures 4A and 4B. Patient with skin type II before and eight months after three LightSheer® treatments.The axilla treatment fluence was 40 J/cm2 and the pulse duration was 20 ms.RESULTS: Long term follow-up in 25 patients showed greater than 60% clearance at six months after treatment. Adverse effects were limited to erythema and edema postoperatively which lasted from 12-24 hours. Crusting and blistering were occasionally seen, however, no evidence of persistent pigmentation disturbances was noted. No textural changes or scarring was noted at any treatment sites.

Light-SheerTM 800 nm Pulsed, High-Power diode Laser Hair Removal System

Robert M. Adrian, M.D., F.A.C.P.

• Longer pulsed durationsare associated with greater efficacy and fewer clinical side effects• LightSheer® diode laserat 800nm is more effective when compared to ruby and alexandrite due to the ability to deliver significant fluences in darker skinned type individuals

Lumenis Inc.

Peer reviewed article

37 Wavelength of 800 nm are safe for dark skin

2001 BACKGROUND AND OBJECTIVE: The 810-nm wavelength diode laser can safely and successfully treat all skin types, including dark pigmented skin.STUDY DESIGN/METHODS: Eight Fitzpatrick level V-VI skin type patients, four of which presented with the diagnosis of pseudofolliculitis barbae, were treated with the diode laser for hair removal using low-energy settings and long pulse duration.RESULTS: All eight patients had excellent results with unwanted hair greatly reduced, and pseudofolliculitis barbae resolved.CONCLUSIONS: Diode lasers can be used on dark pigmented skin with positive outcomes. Complications such as hypopigmentation, or hyperpigmentation occurred, but all were transient and resolved within a few months.

Diode Laser Hair Removal of the Black Patient

Ivanni Greppi Excellent result on dark skin with diode lasers 810-nm

Lasers Surg Med. 2001;28(2):150-5.

White Paper

LightSheer® with chill tip is effective with all skin types (including darker skin)

2000 An 800 nm diode laser with contact cooling and very long pulse widths provides for effective, long-term hair reduction of medium to coarse pigmented hair, even in some darker-skin subjects. Very long pulse widths allow for all skin types to tolerate substantially higher fluences, and thus darker skin types can be safely and effectively treated. Additionally, preliminary results demonstrate that very long pulse widths do not significantly decrease the efficacy for medium to coarse hair reduction for any given fluence.

Study of Very Long-Pulsed (100 ms) High-Powered Diode Laser for Hair Reduction on All Skin Types

Eliot F. Battle, Jr., MD and R. Rox Anderson, MD

Long pulse width allows all skin types to tolerate high fluences

This manuscript is not a medical literature publication. Product information is provided solely for user education.

38

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BACKGROUND: Although numerous lasers are available for laser assisted hair removal, their use in individuals with a dark skin type presents many challenges due to competition from epidermal melanin.OBJECTIVE: Our aim was to evaluate two 800 nm diode lasers (Lightsheer®) with 30 msec and 100 msec pulse durations in the treatment of African American patients with skin types V and VI. Histologic studies, efficacy and side effects were examined in an effort to optimize laser hair removal procedures in this patient population.METHODS: Facial, neck and axillary areas were treated using 800 nm diode lasers at 30 and 100 msec pulse durations with fluences between 15 J/cm2 and 40 J/cm2.RESULTS: Both lasers could be used safely in skin type V and VI African American patients. Longer pulse durations enabled the delivery of higher fluences with minor and acceptable postoperative complication profiles.CONCLUSION: The Lightsheer® diode laser (Coherent Medical, Santa Clara, CA, USA) operating at 30 msec and 100 msec can be safely used in hair removal procedures in African American patients.

Peer reviewed article

39 LightSheer® diode laser with wavelength of 800 nm is safe and effective for dark skin (V-VI)

2000800 Nanometer Diode Laser Hair Removal in African American Patients: a Clinical and Histologic Study

Robert M Adrian & Kathleen P Shay

Long pulse duration at 800 nm enables target fluence to achieve hair reduction in dark skin

J Cutan Laser Ther 2000; 2:

Lasers have been used for hair removal since 1995, but few have had properties that are also effective in treating leg veins. This dose-response study at Wellman Laboratories on 25 patients with 200 treatment sites has determined parameters for an 800 nm high-powered diode laser. It has also resulted in recommendations for patient selection and a treatment protocol. Patients presenting with leg vessels between 0.4 and 1 mm have been shown to respond to laser treatment, with results improving with the number of treatments and with time after treatment.

White Paper

40 Treatment of leg veins with Light-Sheer®

2000Use of an 800 nm High-Power Diode Laser for the Treatment of Leg Vein Telan-giectasia

Valeria B. Campos, MD, R. Rox Anderson, MD, and Christine C. Dierickx, MD

• Recommending patientsselection for treatment and protocol for use• Size of vein responded was0.4-1 milimeter• Higher number of treatmentshows better results

Lumenis, Inc

BACKGROUND: Laser treatment of benign pigmented lesions is becoming an increasingly popular alternative to traditional methods such as dermabrasion, electrodessication, chemical peeling, chemical bleaching, or surgical excision. Numerous laser systems are currently available offering different methods for protecting the epidermis from thermal injury during treatment.OBJECTIVE: To study the effectiveness of 800-nm Lumenis Inc.TM LightSheer® diode laser system with contact cooling in treating benign pigmented lesions in subjects with a variety of skin types.METHODS: An 800-nm, high-energy, long-pulsed diode laser with contact cooling has been used to provide treatment for benign pigmented lesions in subjects with a variety of skin types. The LightSheer® diode laser was used with fluences of 30–40 J/cm2 and pulse widths of 15–30 ms to treat a variety of pigmented skin lesions, including junctional and congenital melanocytic nevi. Subjects received up to 2 treatments at 4–6 week intervals.CONCLUSION: One month after the second treatment 57% of subjects had at least 75% clearing of the lesion, including 20% who had greater than 95% clearing. The overall safety profile was excellent with only minor side effects observed. Detailed descriptions of the use of the LightSheer® laser for pigmented skin lesions are presented.

White Paper

41 Succesful treatments of pigmented lesions with LightSheer®

2000Use of the Light-Sheer® Diode Laser System for the Treatment of Benign Pigmented Lesions

Suzanne Kilmer, MD, Vera A. Chotzen, MD, Marla McClaren, MD

Effective pigmented treatment of lesion for various skin types with only two treatments

Lumenis Inc.

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