Light-based home-use devices for hair removal: Why do they work and how effective they are?

OBJECTIVES: This review has the following objectives: Firstly, it provides an explanation of the evolution of laser/intense pulsed light (IPL) hair reduction modalities from high fluence professional devices to low fluence home-use appliances. Secondly, it summarises published literature reviews on home-use devices (HUDs) as evidence of their growing credibility. Thirdly, it proposes mechanistic differences in light delivery regimes and the resulting divergences in mode of action. MATERIALS AND METHODS: An extensive literature search was performed to review the progress of laser/IPL-induced hair reduction and determine what evidence is available to explain the mode of action of professional and HUDs for hair removal. Establishing the likely biological mode of action of professional high-fluence systems versus home-use low-fluence appliances was performed by combining data obtained using ex vivo hair follicle (HF) organ culture and the clinical results involving human participants. RESULTS: Significant basic science and clinical evidence has been published to confirm the clinical efficacy and technical safety of many laser and IPL home-use devices for hair removal. Clearly, HUDs are different compared to professional systems both in terms of fluence per pulse and in terms of biological mechanisms underlying hair removal. Here we presented data showing that a single low fluence pulse of both 810 nm laser (6.6 J/cm2 , 16 ms) and IPL (9 J/cm2 , 15 ms and 6.8 J/cm2 , 1.9 ms) leads to induction of catagen transition. Catagen transition was characterized by morphological changes similar to what occurs in vivo with occasional detection of apoptosis in the dermal papilla and outer root sheath cells. This suggests that high hair reduction can be expected in vivo and longer-term treatment might result in HF miniaturization due to a cumulative effect on the dermal papilla and outer root sheath cells. In line with this hypothesis, in this review we demonstrate that long-term application of a commercially-available home-use IPL appliance resulted in persistent hair reduction (80%) one year after last treatment. These data are in line with what was previously reported in the literature, where clinical studies with home-use IPL appliances demonstrated high efficacy of hair reduction on female legs, armpits and bikini zones, with full hair regrowth after four treatments following cessation of IPL administration. Limitations of HUDs include lack of hair clearance for very dark skin types and low speed of treatment compared with professional devices. Numerous uncontrolled and controlled clinical efficacy studies and technical safety investigations on consumer-use appliances support many of the leading manufacturers' claims. ANALYSIS & CONCLUSIONS: Manufacturers make consumer appliances safe and easy to use by considering "human factors," needs and capabilities of a variety of users. Safety is of primary concern to manufacturers, regulators and standards bodies as these appliances may be accessible to children or their use attempted on unsuitable skin types without full awareness of potential side effects. Consumer cosmetic appliances are provided with warnings and obvious safety notices describing the nature of any ocular or dermal hazard and precautions for reducing risk of accidental injury, infection, etc. HUDs employing optical energy are provided with design and engineering controls such as safety switches, alarms and sensors to prevent their incorrect operation or eye exposure. In-vivo studies demonstrated that low fluence home-use hair removal devices can result in high hair reduction efficacy after a short treatment regime, while prolonged and less frequent (once in six weeks) maintenance treatment over a year can lead to high and sustained hair reduction even one year after cessation of treatment. Home-use hair removal devices can be a useful adjunct to professional in-office treatments with high professional awareness. There are sufficient positive arguments for practitioners to make the case to patients for HUDs as "companion" products to professional treatments. In addition, devices for hair removal can be used effectively as stand-alone products by the consumer if they are willing to adopt a regime of regular or frequent use. Further clinical studies involving dynamic observation of HF cycle stage and type (terminal vs. vellus) over the total duration of treatment, for example, using biopsies or non-invasive imaging are necessary to confirm the proposed mode of action of low fluence pulses in a combination with treatment and maintenance regimes. Lasers Surg. Med. 51:481-490, 2019. © 2019 Wiley Periodicals, Inc.

Effect of wavelength and beam width on penetration in light-tissue interaction using computational methods.

Penetration depth of ultraviolet, visible light and infrared radiation in biological tissue has not previously been adequately measured. Risk assessment of typical intense pulsed light and laser intensities, spectral characteristics and the subsequent chemical, physiological and psychological effects of such outputs on vital organs as consequence of inappropriate output use are examined. This technical note focuses on wavelength, illumination geometry and skin tone and their effect on the energy density (fluence) distribution within tissue. Monte Carlo modelling is one of the most widely used stochastic methods for the modelling of light transport in turbid biological media such as human skin. Using custom Monte Carlo simulation software of a multi-layered skin model, fluence distributions are produced for various non-ionising radiation combinations. Fluence distributions were analysed using Matlab mathematical software. Penetration depth increases with increasing wavelength with a maximum penetration depth of 5378 µm calculated. The calculations show that a 10-mm beam width produces a fluence level at target depths of 1-3 mm 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. Meaning little additional penetration is achieved with larger spot sizes. Fluence distribution within tissue and thus the treatment efficacy depends upon the illumination geometry and wavelength. To optimise therapeutic techniques, light-tissue interactions must be thoroughly understood and can be greatly supported by the use of mathematical modelling techniques.

Lasers and intense pulsed light (IPL) association with cancerous lesions.

The development and use of light and lasers for medical and cosmetic procedures has increased exponentially over the past decade. This review article focuses on the incidence of reported cases of skin cancer post laser or IPL treatment. The existing evidence base of over 25 years of laser and IPL use to date has not raised any concerns regarding its long-term safety with only a few anecdotal cases of melanoma post treatment over two decades of use; therefore, there is no evidence to suggest that there is a credible cancer risk. Although laser and IPL technology has not been known to cause skin cancer, this does not mean that laser and IPL therapies are without long-term risks. Light therapies and lasers to treat existing lesions and CO2 laser resurfacing can be a preventative measure against BCC and SCC tumour formation by removing photo-damaged keratinocytes and encouraged re-epithelisation from stem cells located deeper in the epidermis. A review of the relevant literature has been performed to address the issue of long-term IPL safety, focussing on DNA damage, oxidative stress induction and the impact of adverse events.

A randomized controlled study for the treatment of acne vulgaris using high-intensity 414 nm solid state diode arrays.

The treatment of acne vulgaris poses a challenge to the dermatologist, and the disease causes emotional anxiety for the patient. The treatment of acne vulgaris may be well-suited to home-use applications, where sufferers may be too embarrassed to seek medical treatment. This randomized controlled study is designed to quantify the effectiveness of using a blue light device in a therapy combined with proprietary creams, in the investigation of a self-treatment regimen. A total of 41 adults with mild-to-moderate facial inflammatory acne were recruited. The subjects were randomly assigned to combination blue light therapy (n = 26) or control (n = 15). Photography was used for qualitative assessment of lesion counts, at weeks 1, 2, 4, 8, and 12. All subjects in the treatment cohort achieved a reduction in their inflammatory lesion counts after 12 weeks. The mean inflammatory lesion counts reduced by 50.02% in the treatment cohort, and increased by 2.45% in the control cohort. The reduction in inflammatory lesions was typically observable at week-3, and maximal between weeks 8 and 12. The treatment is free of pain and side-effects. The blue light device offers a valuable alternative to antibiotics and potentially irritating topical treatments. Blue light phototherapy, using a narrow-band LED light source, appears to be a safe and effective additional therapy for mild to moderate acne.

Pigmentation: selective photothermolysis or non-specific skin necrosis using different intense pulsed light systems?

BACKGROUND AND OBJECTIVE: This study considers end point tissue responses and side effects to determine whether 'square pulse' IPL is more or less effective than the traditional IPL. Supporting histological data and computational modelling results are provided. It provides guidance for IPL users unfamiliar with constant spectrum IPL devices and redirects attention to treatment end points. MATERIALS AND METHODS: Twenty subjects of Fitzpatrick Skin Types I-III, presenting with various epidermal pigmented lesions, were treated 1-3 times with two different IPLs. Coupling gel was used and firm pressure was applied to exclude blood from the treatment area. Immediate and post-treatment side effects, degree of discomfort and end results at fourteen and thirty days were evaluated by professional observation, digital photography and a patient questionnaire. RESULTS: Both IPLs showed a mean clearance of over 80% after 1-3 treatments but the free discharge IPL demonstrated a greater side effect profile with a higher incidence of ulceration, crusting and erythema. CONCLUSIONS: Clinical observation and mathematical modelling suggests that the square pulse, partial discharge IPL system may provide the IPL operator with greater control over the coagulation of pigment and is therefore the more efficient device for effective pigment lightening with fewer side effects.

Mathematical modeling of the optimum pulse structure for safe and effective photo epilation using broadband pulsed light.

The objective of this work is the investigation of intense pulsed light (IPL) photoepilation using Monte Carlo simulation to model the effect of the output dosimetry with millisecond exposure used by typical commercial IPL systems. The temporal pulse shape is an important parameter, which may affect the biological tissue response in terms of efficacy and adverse reactions. This study investigates the effect that IPL pulse structures, namely free discharge, square pulse, close, and spaced pulse stacking, has on hair removal. The relationship between radiant exposure distribution during the IPL pulse and chromophore heating is explored and modeled for hair follicles and the epidermis using a custom Monte Carlo computer simulation. Consistent square pulse and close pulse stacking delivery of radiant exposure across the IPL pulse is shown to generate the most efficient specific heating of the target chromophore, whilst sparing the epidermis, compared to free discharge and pulse stacking pulse delivery. Free discharge systems produced the highest epidermal temperature in the model. This study presents modeled thermal data of a hair follicle in situ, indicating that square pulse IPL technology may be the most efficient and the safest method for photoepilation. The investigation also suggests that the square pulse system design is the most efficient, as energy is not wasted during pulse exposure or lost through interpulse delay times of stacked pulses.

Are home-use intense pulsed light (IPL) devices safe?

The domestic market for home-use hair removal devices is rapidly expanding and there are numerous intense pulsed light (IPL) products now available globally to consumers. Technological challenges for the design of such devices include the need to be cost-effective in mass production, easy to use without training, and most importantly, clinically effective while being eye-safe. However inexpensively these light-based systems are produced, they are designed to cause biological damage to follicular structures, so precautions to prevent both ocular and epidermal damage must be considered. At present, there are no dedicated international standards for IPL devices. This review directly compares three leading domestic IPL hair removal devices: iPulse Personal (CyDen, UK), Silk'n/SensEpil (Home Skinovations, Israel), and SatinLux/Lumea (Philips, Netherlands) for fluence, emitted wavelength spectrum, time-resolved footprint, and spatial distribution of energy. Although each device has a primary mechanical or electrical safety feature to ensure occlusion of the output aperture on the skin to prevent accidental eye exposure, the ocular hazard of each device has been measured to IEC TR 60825-9 standard using an Ocean Optics HR2000+ photo spectrometer for both potential corneal and retinal damage. Using established measurement methods, this review has shown that the measured output parameters were significantly different for the three systems. Using equipment traceable to national standards, one device was judged at its two highest settings to be hazardous for naked eye viewing. This investigation also reports on the significantly different pulse durations of the devices measured and considers the potential impact on safety and efficacy in the light of the theory of selective photothermolysis. Although these devices offer low-cost personal convenience of treatment in the privacy of the home, ocular safety may be inadequate in the event of primary safety mechanism failure.

Measurement of home-use laser and intense pulsed light systems for hair removal: preliminary report.

BACKGROUND: Laser and intense pulsed light (IPL) devices are used routinely by healthcare professionals for hair removal, but laser and light technology devices intended for home use have so far had little impact in the consumer market. However, as multinational companies enter this market, there will be an explosion in the use of such devices by the consumer. OBJECTIVES: This investigation focuses on the technical performance of the devices tested and although no clinical data are presented, the measured parameters are those that will directly impact efficacy in hair reduction, efficient coverage of skin, and safety in terms of unintentional eye exposure to the light source or incorrect settings for a given skin type. Consumers will consult healthcare professionals with experience of light-based therapies for guidance and this study provides useful reference information on available home-use devices. METHODS: Previously published standard test methods were used to evaluate the devices tested. RESULTS: Some of the devices measured in this study showed significant discrepancies between claims made by the manufacturers and the parameters measured. CONCLUSIONS: There is an urgent need for early ratification of the draft international IEC 60601-1 intense light standard, which will encompass manufacturing standards for both professional and home-use hair removal devices.

Relevance of the structure of time-resolved spectral output to light-tissue interaction using intense pulsed light (IPL).

BACKGROUND AND OBJECTIVES: High quality IPLs can offer simple, safe and effective treatments for long-term hair removal, removal of benign vascular and pigmented skin abnormalities, skin rejuvenation and acne treatments. Significant differences in clinical outcome have been recorded among different free-discharge and constant current IPLs despite identical settings. We investigated the differences in optical output of 19 IPLs in normal clinical use in the UK to evaluate spectral output, energy density values and pulse structure and propose a correlation between light-tissue interaction and spectral output as measured by time-resolved photo-spectrometry. STUDY DESIGN/MATERIALS AND METHODS: Using a fast spectrometer, generating 1,000 full spectral scans per second, time resolved spectral data of IPL outputs was captured with a resolution of 0.035 nm. IPL spectral outputs were calculated and graphically modelled using MathCAD software for comparison. RESULTS: Several IPLs, which professed matching of pulse durations to the thermal relaxation times of specific follicular or vascular targets were shown to have effective pulse durations that were vastly shorter than those claimed. Some IPLs claiming 'square pulse' characteristics failed to show constant spectral output across the duration of the pulse or sub-pulses. CONCLUSIONS: This study provides a suitable method to determine accurately key parameters of the emitted light pulses from IPLs and confirms the direct correlation between the electrical discharge current profile and the output energy profile. The differences measured between first generation free discharge systems and modern square pulse systems may have important clinical consequences in terms of different light-tissue interactions and hence clinical efficacy and safety. IPL manufacturers should provide time-resolved spectroscopy graphs to users.

Measuring key parameters of intense pulsed light (IPL) devices.

BACKGROUND: Unlike medical lasers, intense pulsed light (IPL) devices are largely unregulated and unclassified as to degree of safety hazard. With the exception of most of the USA, the United Kingdom and parts of Europe, the Far East and Australia, the sale of IPLs is generally unrestricted, with the majority being sold into the beauty therapy and spa markets. Standards are only imposed on manufacturers for technical performance data and operating tolerances determined by CE-compliance under electrical safety standards or the EU Medical Device Directive. Currently, there is no requirement for measurement of key IPL performance characteristics. OBJECTIVE: To identify the key IPL parameters, emphasize their importance in terms of safe and effective treatment and provide examples of preliminary measurement methods. These measurements can highlight changes in an IPL device's performance, improving patient safety and treatment efficacy. METHODS: Five key parameters were identified as having an important role to play in the way light interacts with the skin, and therefore an important role in patient safety and effective treatment. Simple methods were devised to measure the parameters, which include fluence, pulse duration, pulse profile, spectral output and time-resolved spectral output. RESULTS: The measurement methods permitted consistent and comparable measurements to be made by two of the authors at working clinic locations on 18 popular IPL devices and allowed assessment of output variations. Results showed discrepancies between the measured IPL device outputs and those values displayed on the system or claimed by the manufacturers. The importance of these discrepancies and their impact is discussed. CONCLUSIONS: This study, of 18 popular devices in regular daily use in England and Wales, provides example methods for measuring key IPL device parameters and highlights the need for regular measurement of at least those five key parameters measured in this study. These methods can help service technicians to check performance and eliminate device malfunction.