Lasers Med Sci (2007) 22: 49 DOI 10.

1007/s10103-006-0417-7

ORIGINA L ARTI CLE

C. Ash . G. A. Town . G. R. Martin

Preliminary trial to investigate temperature of the iPulse intense pulsed light (IPL) glass transmission block during treatment of Fitzpatrick II, IV, V, and VI skin types
Received: 6 May 2006 / Accepted: 30 August 2006 / Published online: 21 November 2006 # Springer-Verlag London Limited 2006

Abstract The glass transmission block, a key component of all intense pulsed light (IPL) devices, is responsible for the delivery of IPL energy from the xenon discharge lamp to hair and skin structures during treatment. The purpose of this study was to investigate the variation in temperature of the quartz glass block used in the iPulse (CyDen, Swansea, UK) handset during typical hair removal treatments of Asian and Afro-Caribbean skin types. Initial results from four subjects indicated that the temperature of the glass transmission block did not exceed 45C during any of the treatments. Furthermore, the development of the temperature measurement methodology described in this paper will enable the comparison of data from different IPL systems to be undertaken in a subsequent larger scale trial. Keywords Hair removal . Intense pulsed light (IPL) . Glass transmission block . Temperature measurement

Introduction
An integral component of the handset applicator of all xenon intense pulsed light (IPL) devices used for hair reduction and the treatment of skin conditions is the quartz or sapphire glass transmission block, which delivers broadband, intense pulsed light energy from the xenon lamp to the skin. The size, energy, and discharge specifications of most IPL devices require a cooling circuit where deionized water is pumped around the flashlamp to cool the lamp, filter, and glass transmission block assembly. Moreover, some IPL systems require additional cooling of the glass transmission block (by means of a circulating coolant collar or thermoelectric Peltier cooling device) to keep the transmission block temperature at a comfortable level for the patient and to avoid any side effects from excessive heat buildup while in contact with the skin. A review of the literature on temperature measurement and burn response shows that diathermy and radio frequency (RF) are well-established technologies in clinical medicine usually involving the delivery of RF current to the tissue in a unipolar mode with the current returning to the generator source through a large dispersive electrode. Skin burns at the dispersive electrode site represent serious complications of RF ablation procedures, which have led to a number of studies seeking ways to reduce the incidence of dispersive-electrode-related burns [14]. However, since Goldman and Eckhouse [5] began developing a new IPL (PhotoDerm VL) in the early 1990s, most studies have emphasized positive results with these devices, and there have been relatively few published reports on burn complications or how to avoid them, especially in darker skin types. Miyake et al. [6] determined a predictive method for measuring the increase in temperature during IPL applications to prevent cutaneous lesions during polychromatic light sclerotherapy. The subject of this preliminary evaluation is a patented twin-flashlamp, constant-spectrum, low-temperature, aircooled IPL system (iPulse CyDen, Swansea, UK), which contains neither a colored glass absorption filter nor a water

C. Ash (*) CyDen Ltd., Technium 2, Kings Road, Swansea, SA1 8PH, Wales, UK e-mail: cash@cyden.co.uk Tel.: +44-1792-485618 Fax: +44-1792-485631 G. A. Town GCG Healthcare Ltd., 88 Noahs Ark Lane, Haywards Heath, RH16 2LT, England, UK e-mail: godfreytown@csi.com Tel.: +44-1444-484911 Fax: +44-1444-484357 G. R. Martin Robb Farm, Tuxford Road, Egmanton, Nottingham, NG22 OHA, England, UK e-mail: rossmartin@talk21.com Tel.: +44-115-9827033 Fax: +44-115-9580044

cooling circuit. The twin xenon lamps have cerium-oxidedoped glass envelopes to filter out potentially harmful UV radiation below 400 nm, and the quartz glass transmission block has a dichroic reflectance filter coating to allow only wavelengths above 530 nm to be delivered to the skin. As discussed by Weiss and Weiss [7], the method of application requires the use of a refrigerated (+4C), clear ultrasound gel to cool the skin surface and assist in light transmission through the stratum corneum to dermal and epidermal targets such as hair follicles, thread veins, and benign pigmented lesions. iPulse utilizes partial discharge technology whereby computer software delivers a square pulse electrical discharge to the lamp to ensure constant spectral output for the entire duration of the pulse. In common with many other users of IPL technology, who have employed systems with conventional colored glass absorption filters, users in tropical climates such as those in Southeast Asia, have preferentially used red filters to reduce competitive absorption of shorter wavelengths of light into the epidermal melanin component of darker skin types commonly found in these areas. Therefore, when introduced to iPulse technology, some clinicians in Southeast Asia have expressed concern that the clear quartz block may reach high temperatures that could possibly produce side effects during the treatment of dark Asian skin types that are prone to hyperpigmentation. Therefore, the purpose of this preliminary trial was to investigate the variation in temperature of the glass block used in the iPulse handset during typical hair removal treatments of Asian and Afro-Caribbean skin types. Several preliminary investigations have been carried out to evaluate the characteristics of the iPulse system. The first examined whether different reflective materials used to represent the skin surface being treated have an effect on the temperature of the handset and ultimately the user replaceable lamp (Ash 2005, personal communication). The white fluorocarbon-based polymer, polytetrafluoroethylene (PTFE), was shown to be a suitable laboratory test material substitute for tests on human skin. It was also demonstrated that the temperature of the glass block falls because the subjects cooler skin surface conducts heat away from the glass block as it moves over the skin. A second study evaluated temperature change of the handset during testing of the iPulse i200 and i300 systems (Ash 2005, personal communication). A substantial improvement in temperature reduction was observed using the new iPulse i300 handset. In this study, the glass transmission block under test reached an extremely high temperature (170C) due to the handset being fired against PTFE with no movement or cooling gel applied. The current study described in this paper, although using only four subjects, expands on a preliminary investigation of treatment temperature of the iPulse handset glass block, which included only two subjects (both of skin type II) (Ash 2005, personal communication). The current study is, therefore, more representative of treatments carried out by establishments whose clients often have widely differing skin types.

Additionally, developing a method to measure the heat buildup, if any, in the glass transmission block may better allow comparative data to be gathered for different IPL systems and identify possible causes of unwanted side effects.

Materials and methods

Selection of subjects The subjects used for this investigation were of various skin types. measured using the Fitzpatrick Scale, I to VI. The skin treatment area on all subjects was tested using a ChromoTest melanin measuring system (Dupleix, Denmark) to confirm the skin type with a numerical grade (Fig. 1). The use of the ChromoTest system reduced the risk of human error in skin-type assessment, which could result in ineffective hair removal treatment through incorrect choice of pulse and energy density values. The Fitzpatrick skin type and profile of the four subjects (unpaid volunteers from Swansea University) are summarized in Table 1. Subject D with a skin type II was chosen as a comparison with the three darker skin types. Subjects A, C, and D had previously regularly shaved the area treated in this study using standard wet shaving products. Three days before the treatment measurements were performed, each subject had a test patch (three IPL shots) to ensure suitability for IPL treatment. Before treatment, the subjects completed a case report form, highlighting their medical history, and also signed a treatment consent form. Table 2 shows the treatment information for each subject. Equipment setup and data recording An iPulse i300 IPL was used for the investigation, with the base unit operated using the appropriate pulse durations and energy density (fluence) levels for the skin types

Fig. 1 ChromoTest melanin measuring system (Dupleix, Denmark) for skin type assessment

6 Table 1 Subject profile information Subject Profile Age Sex (M/F) Ethnic origin A B C D 23 28 22 23 F M F F Afro-Caribbean Afro-Caribbean Chinese White Smoker Skin type Yes No No No VI V IV II

selected. A laptop connected to a small Pico temperature data logger (Pico Technology, St. Neots, UK), which had been independently calibrated according to the industry standard protocol immediately before this study, and a thermocouple attached to the handset glass block were used to record the temperature measurements (Fig. 2). The thermocouple, which measured the temperature of the glass block, was placed into a small, 3-mm-deep groove cut in the corner of the glass block using a circular diamond saw. The position and depth of the thermocouple were decided upon to represent the true thermal energy seen at the treatment face without being in contact with the cold ultrasound gel which would reduce the temperature of the thermocouple and distort the results. It can be seen from the computer simulation of the heat transfer through the fused silica glass treatment block (Fig. 3) that with a cut 5 mm from the front of the glass block and at a depth of 3 mm, the temperature at the thermocouple is the same as that seen at the treatment surface center, without having compromised results due to the cold ultrasound gel. As in the previous study, the Pico data logger was sampled at 100 ms intervals, which exceed the Nyquist criteria. However, by sampling at this rate, the heat absorption of light directly onto the thermocouple was seen as sharp transient spikes. These almost instantaneous spikes were ignored as they did not represent the temperature of the glass block but only a transient response of the thermocouple. The iPulse IPL device under evaluation features twin parallel xenon lamps (patent applied for) with reverse orientation of anode and cathode of each lamp to compensate for any concentration of energy emission at
Table 2 Treatment information for subjects AD Subject Body Number Pulse area of shots treated used A Leg L 95 Leg R 94 Back 27 Energy density (J/cm2) Side effects

Fig. 2 iPulse IPL handset showing glass transmission block with attached thermocouple for temperature measurement

C D

Leg Leg Leg Leg

L R L R

65 68 81 85

Triple 310 ms on 10 20 ms off (within pulse train) Triple 310 ms on 10 20 ms off (within pulse train) Single 40 ms 11 Single 30 ms 14

Erythema

None

None None Fig. 3 CAD simulation of heat transfer through an iPulse transmission block illustrating homogeneity of energy distribution (where color change from red to blue denotes temperature gradient)

the cathode. This feature produces a more homogenous energy distribution across the glass transmission block. To simulate the ambient temperature conditions likely to be encountered during skin treatments in air-conditioned clinic rooms in a tropical climate such as south east Asia, room temperature was increased using central heating and a gas fire to between 24 and 27C. Treatment procedure All experimental procedures in this pilot study were carried out in accordance with the standard treatment protocol (Martin 2005, personal communication) and under the supervision of the clinical author who produced it. While formal ethics committee approval was not sought, informed consent was obtained from trial subjects to make these measurements of glass block temperature under normal treatment conditions, which did not involve measuring therapeutic efficacy or any unwanted treatment side effects. The handset was discharged against the patients skin (Fig. 4) using the standard treatment protocol for hair removal (Martin 2005, personal communication). Care was taken not to overlap any areas on the subjects skin. The treatment was undertaken as rapidly as possible to create a worst-case scenario of a patients treatment where there might be a buildup of heat in the glass block from the rapid treatment. The occurrence of any normal side effects such as erythema (skin reddening) was recorded. The iPulse i300 system has an automatic short cooling cycle (43 s) after 50 discharges of the consumable lamp, and the operator cannot discharge the handset during this time while the system is cooling, so it was anticipated that this would create breaks in the data being recorded. Also, groupings of approximately 20 sets of data were expected due to a series of discharges along the length of a leg, then a short break was taken by the operator to prepare the next area for treatment with coupling cooling gel.

Results and discussion

It can be seen that there are two lines on each of the graphs presented in this study (Fig. 5ag). The red, almost constantly horizontal line is the ambient room temperature during testing. From the data, it can be seen that the temperature of the environment during treatment is constantly in the range of 24 to 27C. As anticipated, there were several gaps among the groupings of measurements (Fig. 5a,f, and g), because of the automatic short cooling cycle after 50 discharges of the consumable lamp during which the operator could not continue discharging the lamp. The expected groupings of approximately 20 sets of readings due to a series of discharges along the length of a leg, interrupted by a short break for the operator to prepare the next area for treatment with coupling cooling gel, were noted as a dip on the temperature curve. From inspection of the graph data (Fig. 5), it can be seen that the glass block temperature varies somewhat as it is applied to the patients skin. This can be explained by the fact that as the handset is discharged against the patients skin, it heats both the patients skin and the coupling gel in that area. The handset is then moved to an area where the patients skin and the coupling gel are at a lower temperature than the area that just had IPL treatment. The cooler area of skin and gel absorbs some thermal energy from the glass block, thereby cooling the glass block. The difference in the number of shots used on each subject (Table 1) was due to the difference in body size between subjects, resulting in varying size of treatment surface area. Most notable was subject C who was of shorter stature than subjects A and D and so required fewer shots. The average temperature of the glass block for all subjects was approximately 43C, which was only 6 higher than the core body temperature (the average was evaluated visually from the graph data). Subjects did not feel this average 43C temperature directly due to the coupling gel acting as a thermal barrier between the skin and the glass block surface. During the treatment of the lower back of subject B (Fig. 5c), the glass block had an initial temperature of 19C (due to evaporation cooling of the gel) and increased by less than 1C with each successive discharge before it decreased as the glass block cooled to the ambient temperature. It is the authors understanding that the heat energy absorbed is spread homogeneously through the glass block due to a constant distribution of light through the glass block from the twin lamps. Despite the increase in ambient temperature of approximately 45C in the present study vs the earlier study (Ash 2005, personal communication), the temperature of the glass block peaks at approximately the same temperature in both studies. This may be explained by the greater absorption of light energy by the darker skin type than the lighter skinned subjects in the earlier trial, with correspondingly less reflection of energy back into the handset body. Subjects B, C, and D felt comfortable during the treatment of hair removal with no post treatment erythema

Fig. 4 Hair removal treatment procedure

Fig. 5 ag Temperature recordings of the iPulse quartz glass transmission block for subjects AD. The red line is the ambient room temperature, while the blue line is the block temperature shown over time, which did not exceed 45C

(redness) or side effects. Subject A experienced slight erythema probably caused by overlapping of adjacent spots. These treatment-related observations would have had no effect on the recorded results. It is worth reflecting that, in the Miyake et al. study [6], while treatments were performed on 20 female subjects of Fitzpatrick skin types IIV, the study used a conventional free-discharge IPL, with 515 nm cutoff filter, and a 6-ms single short pulse output, parameters that are rarely used on skin types III and IV. Miyake also proposed shooting the IPL with the light guide removed from the skin surface as this facilitated simultaneous temperature measurement using his test method and resulted in a complete absence of side effects including an absence of any pain sensation. Given the extremely high divergence angle of polychromatic light emitted from a glass transmission block, it is also likely that the light energy reaching the tissue would have been ineffective in treating the target lesion. In a comprehensive review of thermal thresholds for tissue damage from hyperthermia based on measured surface temperatures, Dewhirst et al. [8] observed very little cytotoxicity for up to 5 h of heating at 42C in hamster models in vitro, while in human and porcine studies in vivo, the timetemperature relationships to achieve ear tissue necrosis are far lower for mouse ear than for the skin of human/pig. Activation energies gave breakpoints of 47C for man and pig and 42.5C for mouse. Moritz and Henriques [9] also reported that heating of human skin to a temperature of 44C for 5 h (600 CEM 43C) resulted in only mild hyperemia in two subjects. The authors of the current study do not therefore consider the measured maximum temperature of 43C to be of concern as the exposure time on any given area of 8.9 cm2 of skin (the area of the glass IPL transmission block) would never be longer than 110 ms with a single pass treatment.

transmission block during treatments on skin types II, IV, V, and VI and that other than normal erythema, no side effects were recorded. Based on these encouraging results, a larger scale controlled trial with higher treatment fluences and complete treatment courses should be undertaken to validate these initial findings and show that iPulse7 is therefore safe to use on darker skin when used as described in the iPulse treatment protocol. The use of a digital thermal imaging camera could be used in subsequent studies to observe directly the temperature of the patients skin and the thermal dissipation properties of the subjects skin.

References
1. Thiagalingam et al (2005) A thermochromic dispersive electrode can measure the underlying skin temperature and prevent burns during radiofrequency ablation. J Cardiovasc Electrophysiol 7:781788 2. Steinke K, Gananadha S, King J, Zhao J, Morris DL (2003) Dispersive pad site burns with modern radio frequency ablation equipment. Surg Laporosc Endosc Percutan Tech 13:366371 3. Aigner N, Fialka C, Fritz A, Wruhs O, Zoch G (1997) Complications in the use of diathermy. Burns 23:256264 4. Neufeld GR, Foster KR (1985) Electrical impedance properties of the body and the problem of alternate-site burns during electrosurgery. Med Instrum 19:8387 5. Goldman MP, Eckhouse S (1996) Photothermal sclerosis of leg veins. ESC Medical Systems, PhotoDerm VL Cooperative Study Group. Dermatol Surg 22:323330 6. Miyake RK, Miyake H, Kauffman P (2001) Skin temperature measurements during intense pulsed light emission. Dermatol Surg 27:549554 7. Weiss RA, Weiss MA (2001) Noncoherent filtered flashlamp intense pulsed light device. In: Lyons K (ed) Lasers in aesthetic surgery. Thieme, New York, p 196 8. Dewhirst MW, Viglianti BL, Lora-Michiels M, Hanson M, Hoopes PJ (2003) Basic principles of thermal dosimetry and thermal thresholds of tissue damage from hyperthermia. Int J Hyperthermia 19(3):267294 9. Moritz A, Henriques F (1947) Studies of thermal injury II. The relative importance of time and surface temperature in the causation of thermal burns. Am J Pathol 23:695720

Conclusions
Using iPulse technology, brief temperature rises up to approximately 43C were measured within the glass