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Do Home-use Hair Removal Lasers & Intense Light Devices Deliver What They Promise - Godfrey Town & Caerwyn Ash

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48 JOURNAL OF COSMETIC SURGERY & MEDICINE | VOL 5 NO 3 2010
Do Home-use Hair Removal
Lasers & Intense Light Devices
Deliver What They Promise?
by
Godfrey Town
University of Wales,
Faculty of Applied
Design & Engineering,
Swansea Metropolitan
University, Swansea,
SA1 6ED, UK
Caerwyn Ash
PhD
School of Medicine,
Swansea University,
SA2 8PP, UK
Enquiries:
Godfrey Town,
88 Noah’s Ark Lane,
Lindeld, West Sussex,
RH16 2LT,
United Kingdom.
Email: godfreytown@
mac.com
ABSTRACT
Background In the past two years since their first
introduction, there has been a rapid proliferation of
light-based hair removal devices intended for home
use. In Europe, sales already run into several tens of
thousands of units, with multinational companies
such as Phillips, Remington and Alliance Boots
entering the market.
Objectives This study expands on a preliminary
study and investigates the technical performance
of a wider range of devices tested with particular
focus on recognised critical parameters for the
safe and effective use of light-based technology in
hair removal. The study also catalogues measured
values against manufacturers’ stated claims and
examines likely suitability for different skin types.
Materials and 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.
Discussion and conclusions There is an urgent
need for regulation of intense pulsed light devices,
which will include manufacturing standards for both
professional and home-use hair removal devices.
Keywords
Home use device, hair removal, optical hazard,
spectral output, square pulse
INTRODUCTION
Several leading laser and intense pulsed light
(IPL) manufacturers have developed miniaturised
systems to meet the needs of the domestic
consumer wishing to undertake depilation in the
privacy of their own home and at a price cheaper
than a professional service. This has required
manufacturers to focus on safety measures for
home-use devices to limit the risk of accidental
injury to the skin and eyes of the user.
The cost reduction needed to bring retail
prices into the range of middle class consumers
necessarily results in treatments with these
systems being slower to use, having smaller spot
sizes on tissue and delivering lower power than
professional systems.
The lack of any current legislation controlling
required performance parameters of non-
medical consumer laser and IPL devices has
resulted in a number of products being offered
for sale without evidence-based data on safety
and clinical efficacy. Moreover, the training ethos
found in professional clinics has to be mirrored
in the adequate provision of information to
consumers and safety restrictions to prevent
accidents or abuse.
While home-use devices may offer greater
privacy and personal convenience to the
consumer than professionally delivered
hair removal treatments and a reduction in
the cost of maintaining hair-free skin for
extended periods, education of the consumer
in light-based treatments is more difficult than
traditional methods of consumer depilation.
Comprehensive education materials, DVDs and
web-based consumer care support are necessary
features of the successful marketing of such
devices to the general public who are otherwise
unaware of the potential implications of solar-
induced post-inflammatory hyperpigmentation1
and the use of some photosensitive drugs and
herbal remedies, which can lead to side effects.
Professional providers are able to accommodate
safely a wider range of skin types and provide
faster and possibly longer lasting treatments
than are attainable with home-use systems.
Domestic devices may still play a significant
part in removing unwanted body and facial hair
among the general public unable or unwilling to
pay for professional treatments.
Although the popularity of laser hair removal
has grown rapidly over the past decade, the
majority of women are reluctant to try other
methods than those used traditionally, such as
plucking, shaving, waxing, ‘sugaring’, chemical
depilatory creams, threading and electrolysis.
JOURNAL OF COSMETIC SURGERY & MEDICINE | VOL 5 NO 3 2010 49
MATERIALS AND METHODS
The measurement methods used in this study
were those reported in previously published
studies on the evaluation of professional IPLs2
and home-use hair removal devices3. The five key
technical parameters being: (i) radiant exposure
(fluence); (ii) pulse duration (or sub-pulse
durations in a pulse train); (iii) spectral emission;
(iv) electrical discharge shape across the xenon
lamp and/or time-resolved spectral “footprint”
(IPL); and (v) spatial distribution of energy over
the device output aperture on tissue. The devices
were purchased through distributors or public
websites or borrowed from users to ensure
normal production quality and performance.
The following general information was
recorded and checked in this study:
Device identity (manufacturer, name, model,
serial number, manufacturing date);
CE classification (eg, medical device or
consumer electrical safety) / labeling details;
Lifetime output claimed in the company
literature, web site, user manual, etc;
Treatment area (dimensions of glass
transmission block or output aperture);
Repetition rate between emission of pulses;
Details of application technique.
The systems evaluated in this report included:
Tria (Tria Beauty Inc, CA, USA), Rio Salon
Laser, IPL 8000 (Dezac Ltd, UK), Rio Scanning
Laser (Dezac Ltd, UK), iPulse Personal
(CyDen Ltd, UK), Silk’n and SensEpil
(HomeSkinovations, Yokneam, Israel), Viss
(Vissbeauty, Korea), i-Light/LumaSmooth
(Remington, USA), Teny Epil Flash (GHT
Innovation, France), E-One (E-Swin, France)
and Lumea (Philips, Eindhoven, Netherlands).
DEVICE-RELATED FACTORS
AFFECTING TREATMENT EFFICIENCY
Fluence IPL and laser fluence (or more
correctly “radiant exposure”) is the amount
of light energy delivered per unit area and is
measured in Joules per cm2. In effective hair
removal using lasers and IPL devices, optical
energy is absorbed principally by melanin in
the hair shaft and hair bulb and converted into
thermal energy. The optimum fluence will raise
the temperature of the chromophore (melanin)
to a level that causes irreversible damage to the
hair follicle and adjacent structures but will not
produce adverse side effects such as burns or
blisters. Too low energy may result in under-
treatment and user dissatisfaction and has been
associated with stimulation of hair growth4.
Pulse duration Although the precise
mechanism of hair removal is not fully
understood, with long-pulsed lasers and IPL
devices it is thought to be caused by selective
thermal damage to the hair follicles. According
to Anderson and Parrish, the optimum pulse
duration should be less than or equivalent to
the thermal relaxation time (TRT) of the target
chromophore5.
If the pulse duration is considerably shorter
than the TRT of the hair follicle, as in the case
of Q-Switched Nd:YAG with pulse durations
below 50ns, complete regrowth of hair at three
months can be expected6. If the pulse duration
is too long, the heat diffuses to surrounding
tissue rendering hair removal ineffective and
increasing the risk of adverse side effects7. High
photon density occurring during short IPL
pulse durations at high fluence also increases
discomfort for the patient and the risk of
collateral tissue damage.
Fig 1. Home-use hair removal devices measured in this study. From top left: Tria (Tria Beauty Inc, CA, USA), Rio Salon Laser, Rio Scanning Laser (Dezac Ltd, UK), iPulse
Personal (CyDen Ltd, UK), Silk’n and SensEpil (HomeSkinovations, Yokneam, Israel), i-Light/LumaSmooth (Remington, USA), Teny Epil Flash (G HT Innovation, France),
IPL 8000 (Dezac Ltd, UK), E-One (E-Swin, France), Lumea (Philips, Eindhoven, Netherlands) and Viss (Vissbeauty, Korea).
50 JOURNAL OF COSMETIC SURGERY & MEDICINE | VOL 5 NO 3 2010
Spectral footprint (IPLs) The time-resolved
spectrum of light delivered throughout the
pulse, confirms the biologically effective
duration of an IPL pulse during which, the
desired wavelengths are delivered in the
optimum intensity. The time-resolved spectra
were produced in this study using an Ocean
Optics HR2000+ spectrometer (Ocean Optics,
Dunedin, FL 34698, USA) and its counterpart
Spectra Suite software, to provide 3-D
visualisation of the pulse structure by time and
wavelength distribution8.
Spectral emission The optimum wavelengths
for the treatment of adult adrogenic terminal
hair is 590-900nm, which provides both
adequate melanin absorption and sufficient
penetration into the dermis to achieve selective
heating of the hair shaft, hair follicle epithelium
and hair matrix including pluripotential stem
cells in the region of the bulge at depths of
approximately 2-4.75mm9. Measurement of
the spectral output also provides information
on any undesirable wavelengths, such as
ultraviolet and infrared radiation, which can
present immediate and long-term health
risks10,11.
Spatial distribution of energy ‘Hot spots’
of over-treatment resulting in pain, blisters,
crusting or hyperpigmentation, and areas of
under-treatment resulting in early hair regrowth
or leukotrichia are a common occurrence when
reviewing different devices and side-effects
after professional IPL depilation1, 3, 12, 13.
Optical alignment, polarity of flashlamps,
light transmission materials and surface
finishing of the glass medium used to conduct
broadband light to the skin surface can all
affect homogeneity of energy delivered across
a treatment spot on tissue.
For the purposes of this investigation, it
was considered adequate to record energy
distribution patterns on laser alignment paper
(Zap-It Corp., Salisbury, NH 03268, USA)
and analyse them using custom software to
produce assessable histograms to determine
the approximate energy distribution pattern.
TEST RESULTS
Manufacturers’ general device information is
recorded in Table 1.
Table 2 records radiant exposure (fluence)
and wavelength data, both claimed and verified,
Do Home-use
Hair Removal
Lasers &
Intense Light
Devices
Deliver What
They Promise?
by
Godfrey Town
University of Wales,
Faculty of Applied
Design & Engineering,
Swansea Metropolitan
University, Swansea,
SA1 6ED, UK
Caerwyn Ash
PhD
School of Medicine,
Swansea University,
SA2 8PP, UK
Enquiries:
Godfrey Town,
88 Noah’s Ark Lane,
Lindeld, West Sussex,
RH16 2LT,
United Kingdom.
Email: godfreytown@
mac.com
showing a significant difference between stated
and measured values for the GHT Epil-Flash.
Table 3 shows the variation in stated and
confirmed pulse durations as measured by a
reversed biased photodiode, spot size, repetition
rate and calculated coverage rates per 30cm2
(claimed and verified). The different devices
show a great variation in the pulse duration to
deliver optical radiation for hair removal and
widely varying total treatment times.
As a result of the very wide variation in the
results recorded for the GHT Epil-Flash versus
the manufacturer’s claims, a second device was
purchased from another vendor and retested.
The measured data for the second device was
found to be identical to the first.
In notes to the data on Table 3 an explanation
is given where the calculated coverage rates per
30cm2 are at variance with the coverage rates
attained in accordance with the manufacturer’s
instructions for use.
The spectral distribution graphs confirm the
wavelength of the diode lasers and show the
cut-on filter position for each of the IPLs. Only
the GHT Epil-Flash recorded a significant UV
component indicating absence of any effective
filtering below 500nm.
Time-resolved 3D spectral images of each IPL
permitted a more accurate visual assessment
of the “biologically effective” pulse duration.
There is a clear contrast between the free
discharge devices (HomeSkinovations Silk’n/
Sensepil, Philips Satinlux/Lumea and Dezac
Rio IPL 8000) and the “managed” discharge
systems (iPulse Personal, E-One and i-Light/
LumaSmooth).
Spatial profile images confirm that the diode
lasers have relatively small treatment areas
on tissue and the histograms indicate a poor
energy distribution for some of the IPL devices
measured.
Safety Features All of the devices tested
featured primary optical safety systems
including: (i) small mechanical spring switches
used to activate the discharge of energy to the
user’s skin; (ii) switches that make contact
when the handpiece is pressed against the
user’s skin and a trigger button on the rear of
the handpiece is depressed simultaneously;
(iii) skin-sensitive electrical conductance safety
systems comprising contact pins, which all
must be in contact with coupling gel and/or
JOURNAL OF COSMETIC SURGERY & MEDICINE | VOL 5 NO 3 2010 51
Fig 2. Spectral distribution of tested systems taken at maximum fluence showing the varying degrees of UV filtering by the IPL systems and the spectral position of
the monochromatic lasers (810nm).
Fig 3. Example of time-resolved spectral footprint images of three IPL systems of 25ms, 3ms and 2ms pulse duration. The Silk’n and Philips devices are free-discharge
IPL systems with a correspondingly more marked spectral shift during their short pulse (3).
Fig 4. Spatial profile of measured systems (top left to right: Philips SatinLux Lumea, Dezak Rio IPL8000, HomeSkinovations Silk’n, HomeSkinovations Sensepil,
Remington i-Light/LumaSmooth, CyDen iPulse Personal; Bottom left to right: Dezac Rio Scanning Laser Hair Remover, Dezac Rio Laser Hair Remover, Tria Beauty,
Tria) showing the diode lasers have relatively small treatment areas and the histograms indicate poor energy distribution for some of the IPL devices.
52 JOURNAL OF COSMETIC SURGERY & MEDICINE | VOL 5 NO 3 2010
Do Home-Use
Hair Removal
Lasers &
Intense Light
Devices
Deliver What
They Promise?
by
Godfrey Town
University of Wales,
Faculty of Applied
Design & Engineering,
Swansea Metropolitan
University, Swansea,
SA1 6ED, UK
Caerwyn Ash
PhD
School of Medicine,
Swansea University,
SA2 8PP, UK
Enquiries:
Godfrey Town,
88 Noah’s Ark Lane,
Lindeld, West Sussex,
RH16 2LT,
United Kingdom.
Email: godfreytown@
mac.com
skin for the device to be active and discharge
energy; (iv) devices which require entry of a
security code to activate the system to prevent
misuse by children; and (v) an electrical contact
system close to the laser aperture, which has to
be broken and re-made before each discharge.
Lasers and LEDs should be tested under
current international standard IEC 60825-
1:2001 to ensure that emissions are below
Exposure Limit Values for a Class 1 or Class
1M laser, ie, “eye-safe”. In the absence of an
internationally recognised standard for intense
light sources, manufacturers of home-use
IPL devices should test to the national safety
standard BS 8497-2:2008 to calculate retinal
thermal hazard of IPL devices in the event
of failure of skin contact sensors or failure of
safety pressure switches designed to prevent
accidental emission of optical radiation14.
All manufacturers of such home-use devices
must ensure the Weighted Radiance Values are
less that the Exposure Limit Values for retinal
thermal hazard. In this study these safety
values were only calculated for one of the IPL
devices to establish the feasibility of producing
a table of Exposure Limit Values and Weighted
Radiance Values for each device setting. The
Weighted Radiance Values for the CyDen iPulse
Personal were found to be below the Exposure
Limit Values for all settings. Thus, with this
device, there is no requirement for the use of
safety eyewear15.
DISCUSSION
The comparative measurements presented
here show all systems to be different in
radiant exposure, pulse duration and spectral
distribution characteristics. The manufacturers
have chosen methods to deliver optical
energy from their devices with the intention
of disabling hair follicles while producing
a profitable and robust product that can be
mass produced. While trying to satisfy these
parameters, clinical efficacy compared with
professional systems may be sacrificed.
Domestic optical hair removal systems
operate under the same principle of selective
photothermolysis as professional IPL/laser
systems with several peer-reviewed articles
confirming efficacy16-20. The optical energy of
suitable wavelengths is emitted and absorbed
by melanin and other chromophores in the
user’s skin within a time constant that heats
the actively growing hair shaft and hair bulb
to temperatures of 65-70ºC, causing sufficient
damage to the hair follicle and adjacent
structures to prevent or delay its regrowth.
The progression of professional hair removal
from the clinic or beauty centre into the home
for use by the consumer, brings with it a risk
of injury to the skin and eyes of consumers
through misuse or failing to follow instructions
properly. Such risks in clinics and salons are
reduced by sufficient training, support and
advice from experienced professionals who are
also able to screen-out unsuitable individuals
or skin types. Evaluation by the authors of the
safety mechanisms employed in the devices
shows they are not too complex, and simple
mechanical switches are sufficient to show
the device is in good contact with the skin
and reduce the risk of eye exposure, misuse or
accidental injury.
All systems are attractively packaged with
clear educational material for the customer
concerning contraindications to treatment
such as too dark skin types, active suntan
and contraindicated medications. However,
what cannot be so easily accommodated is
the inappropriate purchase and use of such
devices by darker skin types than those advised
by the manufacturer. There is also scope for
misjudgment of skin tone when selecting
output settings and consequential unpleasant
skin reactions caused by excessive radiant
exposure for that skin type or under-treatment
resulting in poor efficacy in reducing hair and
ensuing disappointment for the consumer.
Attempts have been made by some
manufacturers, particularly in the USA, to
address these problems such as shipping units
to customers that then require an activation
code from the manufacturer before the device
can be used. This gives the manufacturer the
chance to attempt to check the user is of the
correct skin tone to use the device.
The US FDA has also taken a lead by initially
restricting the sale of some home-use light-
based hair removal devices to be used under
the direction of a physician, after training by
a healthcare professional. Moreover, future
devices intended for over-the-counter sale
to consumers may have to be equipped with
skin sensor technology to ensure they cannot
JOURNAL OF COSMETIC SURGERY & MEDICINE | VOL 5 NO 3 2010 53
be used on unsuitable dark skin types or on
tanned or inappropriate pigmented skin areas.
In the absence of any recognised international
standard, the UK national safety standard (BS
8497-2: 2008) should be used by manufacturers
to calculate eye hazard of IPL devices in the event
of failure of contact or safety pressure switches
designed to prevent accidental emission of
optical radiation. Until a dedicated standard for
home-use lasers and IPL devices is produced,
all manufacturers should test self-use products
against this standard and ensure the Weighted
Radiance Values are less than the Exposure Limit
Values for retinal thermal hazard.
The arrival of trusted brands of home-use
hair removal laser and IPL devices from multi-
national consumer companies may expand
public awareness and acceptance of aesthetic
light-based technologies and lead to an
increase in demand for professionally delivered
therapy rather than to a decline in clinic-based
treatments.
CONCLUSIONS
For optimum hair reduction, the user should
choose a device that delivers sufficient energy
within each pulse or pulse train that is within
the thermal relaxation time (TRT) of the entire
terminal hair follicle including stem cells
(20-100ms) and that is adequate to achieve
histologically evident hair bulb damage or at
least prevent any regrowth for an extended
period20. Only the iPulse Personal, E-one and
the Tria laser had settings that met both of these
criteria while the Philips Lumea and Remington
i-Light/LumaSmooth only included fluence
settings that exceeded the required threshold
for permanent photo epilation.
The measured pulse durations and fluence
settings of the three devices tested, GHT Epil-
Flash (<3ms/max 0.18J/cm2), Vissbeauty, Viss (5-
7ms/max 3.64J/cm2) and the Rio Salon/Scanning
Laser (3.5ms/max 0.3J/cm2) and Rio IPL8000
(3.5ms/max 3.05 J/cm2) did not meet the criteria
as set down by Manstein et al21.
The ability to vary the energy density on
home-use hair removal devices will better
allow the user control and flexibility of treating
different Fitzpatrick skin types.
It is clear the design of some of the
devices measured for this study have had
to compromise product performance with
reducing manufacturing costs. Inefficiency of a
home-use device may well cause frustration and
dissatisfaction to the user, due to long treatment
times and greater frequency of use.
While all of the devices included adequate
safety features to prevent accidental eye
exposure, additional safety measures are
needed to ensure that home-use hair removal
systems are not used on recently suntanned
skin and that treatment is restricted to body
areas of the appropriate skin tone.
There is an urgent need for dedicated
standards for home-use laser and IPL
devices, which could be developed under
the IEC 60335 series (Household and similar
electrical appliances, Safety – Part 1: General
requirements). Meanwhile, home-use lasers
should be tested as far as possible to the
published IEC 60601-2-22 standard (Medical
electrical equipment Part 2-22: Particular
requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic
and diagnostic laser equipment) and home-
use IPL devices should be tested to the draft
international IEC 60601-2-57 intense light
standard (Medical electrical equipment – Part
2-57: Particular requirements for the safety and
essential performance of non-laser light source
equipment intended for therapeutic, diagnostic,
monitoring and cosmetic/aesthetic use),
which encompass manufacturing standards.
Home-use IPL devices should also tested to
BS 8497-2: 2008 (BS 8497-2: 2008 Eyewear for
protection against intense light sources used on
humans and animals for cosmetic and medical
application. Part 2: Guidance on use.) to ensure
eye safety.
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microsurgery by selective absorption of pulsed radiation.
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DISCLOSURES
Godfrey Town is a PhD student at the University
of Wales and receives consultancy fees and
travel grants from CyDen Ltd, Swansea, SA1
8PH, UK and Unilever, Trumball, CT 06611,
USA.
Caerwyn Ash, is a PhD Graduate at University
of Wales and receives travel grants from the
university. He also receives salary from Cyden
Ltd, Swansea, SA1 8PH, UK and has a minor
stock holding in the company.
Do Home-Use
Hair Removal
Lasers &
Intense Light
Devices
Deliver What
They Promise?
by
Godfrey Town
University of Wales,
Faculty of Applied
Design & Engineering,
Swansea Metropolitan
University, Swansea,
SA1 6ED, UK
Caerwyn Ash
PhD
School of Medicine,
Swansea University,
SA2 8PP, UK
Enquiries:
Godfrey Town,
88 Noah’s Ark Lane,
Lindeld, West Sussex,
RH16 2LT,
United Kingdom.
Email: godfreytown@
mac.com
JOURNAL OF COSMETIC SURGERY & MEDICINE | VOL 5 NO 3 2010 55
Table 2: Table records manufacturers’ device information with fluence and wavelength dat a, both claimed and verified showing a significant difference between
stated and measured values for the GHT Epil-Flash.
Table 3: Table shows the variation in stated and measured pulse duration as verified by a reversed biased photodiode, spot size, repetition rate and calculated
coverage rates per cm2 (claimed and measured). The different devices show a great variation in the pulse duration to deliver optical radiation for hair removal and
widely varying total treatment times.
*12.2 sec/cm2 using recommendations in Instructions for Use (pages 40-44).
*
... 23 When tested by independent researchers, the manufacturer's claimed wavelength of 530 to 1,100 nm and fluence of 7 to 10 J/cm 2 were reproduced. 24 In a study by Emerson and Town 25 using the original iPulse personal, 29 patients with skin types I to III achieved hair count reductions of 47% (p < .01) and 41%(p < .01) ...
Article
Full-text available
As the market for home-use light-based and laser-based devices grows, consumers will increasingly seek advice from dermatologists regarding their safety and efficacy profiles. To review the literature on home-use hand-held devices for various dermatologic conditions. To educate dermatologists about commercially available products their patients may be using. A comprehensive literature search was conducted to determine the safety and efficacy of home-use laser and light devices for the treatment of the following: hair removal, acne, photoaging, scars, psoriasis, and hair regrowth. In addition, a thorough search of the Food and Drug Administration's (FDA) radiation-emitting electronic products' database was performed; by searching specific product codes, all hand-held devices that are FDA-approved for marketing in the United States were identified. Of the various home-use devices reviewed, intense pulsed light (IPL) for hair removal and light-emitting diode (LED) for treatment of acne have the most published data. Although the literature shows modest results for home-use IPL and LED, small sample sizes and short follow-up periods limit interpretation. There is a paucity of randomized, double-blind controlled trials to support the use of home-use laser and light devices; smaller, uncontrolled industry-sponsored single-center studies suggest that some of these devices may have modest results.
Chapter
The guidelines presented in this chapter (which represent a proposal of the above-mentioned authors) regulate the education and further training of users who carry out treatments with lasers and “other optical radiation sources” (AOS) with comparable effects (e.g., IPL = intense pulse light or similar) on the human skin. These guidelines serve as the necessary proof of knowledge about physics, biological effects, and basic anatomical knowledge for the correct application and avoidance of damage and undesired effects. This must be ensured and proven by appropriate, professional theoretical (technical knowledge) and practical (technical knowledge) training, and application-specific instruction and further training (certificate of activity, training, and qualification certificate), e.g., by successful participation in appropriate training at a (state-recognized) or accredited body or specially designated training institutions. The most important aspects are presented in this chapter. The present guidelines, which represent a proposal of the abovementioned authors, regulate the education and further training of users who carry out treatments with lasers and “other optical radiation sources” (AOS) with comparable effects (e.g., IPL = intense pulse light or similar) on the human skin. These guidelines serve to provide the necessary proof of knowledge – in accordance with MDR and NiSG – about physics, biological effects, and basic anatomical knowledge for the correct application and avoidance of damage and undesired effects. This must be ensured and proven by appropriate, professional theoretical (technical knowledge) and practical (technical knowledge) training and application-specific instruction and further training (certificate of activity, training, and qualification certificate), e.g., by successful participation in appropriate training at a (state-recognized) or accredited body or specially designated training institutions. The training ends with an oral, written, and practical examination. It should be noted that only port-wine stain and hemangioma are offered as standard benefits under the SHI system and are therefore currently the only recognized medical indications. All other indications are essentially performed as cosmetic indications and only in individual cases as medical treatments. Examples of quality assurance within the scope of the NiSG can be found in ultrasound ( + working groups) as well as in radiation protection itself, which strictly regulates training. These regulations were made on the basis of the assumption of possible damage and have been legally binding for many years [http://www.degum.de/aktivitaeten/qualitaetssicherung.html, http://www.bmub.bund.de/fileadmin/bmu-import/files/pdfs/allgemein/application/pdf/rl_strlschv_strlschmed_bf.pdf]. In the area of application in question here, there are therefore also high demands on the level of training of the users.
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Die in diesem Kapitel vorliegenden Richtlinien (die einen Vorschlag der o.g. Autoren darstellen) regeln die Aus- und Fortbildung von Anwendern, die Behandlungen mit Lasern und „Anderen Optischen Strahlungsquellen“ (AOS) mit vergleichbaren Wirkungen (z. B. IPL = Intense Pulse Light o. ä.) an der menschlichen Haut durchführen. Diese Richtlinien dienen zum erforderlichen Wissensnachweis über die Physik, die biologischen Wirkungen und dem anatomischen Grundwissen zur richtigen Anwendung und Vermeidung von Schäden und unerwünschten Wirkungen. Dies ist durch entsprechende, fachgerechte theoretische (Fachkunde) und praktische Ausbildung (Sachkunde) und anwendungsspezifische Einweisung und Weiterbildung sicherzustellen und nachzuweisen (Tätigkeitszeugnis, Schulungs- und Befähigungsnachweis), z. B. durch erfolgreiche Teilnahme an einer entsprechenden Schulung einer (staatlich) anerkannten oder akkreditierten Stelle oder besonders zu benennende Ausbildungsinstitutionen. Die wichtigsten Aspekte dazu werden in diesem Kapitel vorgestellt.
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Intense pulsed light (IPL) systems have evolved and crossed over from the clinic to the home. Studies have shown home-use IPLs to be clinically effective but there has been no published data on ocular safety. It was our aim to measure the spectral and temporal optical radiation output from a home-use IPL and assess the ocular hazard. The iPulse Personal is a new home-use IPL hair reduction system. We measured its optical radiation spectral output using a calibrated diode array spectrometer that was traceable to national standards. Pulse duration was determined by measurement with a fast photodiode. The results from these measurements were used to assess the optical radiation hazard to the human eye. Retinal thermal hazard (RTH), blue light hazard (BLH), and infrared radiation hazard to the cornea and lens were assessed in accordance with IEC TR 60825-9 and the International Committee on Non-Ionizing Radiation Protection (ICNIRP) Guidelines on Limits of Exposure to Broad-band Incoherent Optical Radiation, as there are no specific international IPL standards. Neither the BLH radiance dose nor the infrared radiation hazard to the cornea and lens irradiance exceeded the exposure limit values (ELVs) set by the ICNIRP. The RTH radiance, however, was exceeded at a fluence of 11 J cm(-2) and pulse duration of 16 milliseconds. Following these results the settings on the IPL were adjusted and the RTH was no longer exceeded at a new fluence of 10 J cm(-2) and pulse duration of 26 milliseconds. The home-use device that we assessed does not present an optical hazard according to currently available international standards.
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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. 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. Previously published standard test methods were used to evaluate the devices tested. Some of the devices measured in this study showed significant discrepancies between claims made by the manufacturers and the parameters measured. 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.
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To determine the most effective treatment parameters for laser-assisted hair removal using a Q-switched neodymium:yttrium-aluminum-garnet (Nd:YAG) laser. Prospective study to determine the effectiveness of Q-switched ND:YAG laser-assisted hair removal under varying pretreatment protocols. Hair growth was assessed after laser treatment, and the results were compared with those of wax epilation at 4, 12, and 24 weeks. A private ambulatory laser facility and academic referral center. Laser-assisted hair removal was performed under 4 different pretreatment conditions. Eighteen areas of unwanted body and facial hair from 12 study subjects were divided into 4 quadrants. Wax epilation followed by application of a carbon-based solution and exposure to Q-switched Nd:YAG laser radiation was performed on 1 quadrant. A second quadrant was wax epilated and exposed to Q-switched Nd:YAG laser radiation without prior carbon solution application. A third quadrant was exposed to laser radiation alone, and a final quadrant was wax epilated to serve as the control. Follow-up evaluations at 1, 3, and 6 months consisted of photographic documentation, manual hair counts, and patient hair-density estimates. Percentage of hair regrowth as assessed by objective hair counts and patient subjective evaluations. Mean percentage of hair regrowth at 1 month was 39.9% for the wax-carbon-laser quadrant, 46.7% for the wax-laser quadrant, 66.1% for the laser-alone quadrant, and 77.9% for the wax control quadrant. The percentage of hair regrowth approximately doubled by 3 months but was significantly delayed in all laser-treated quadrants regardless of pretreatment protocol. Full hair regrowth in all anatomic locations was observed by month 6. Patient subjective evaluations of hair density closely approximated hair count data. No adverse effects or long-term complications were observed. A single hair-removal treatment with the Q-switched Nd:YAG laser is safe and effective in delaying hair growth for up to 3 months. Although the combination of pretreatment wax epilation and topical carbon solution application was effective, laser irradiation alone, with or without wax epilation, also provided a significant delay in hair growth.
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Background. Postinflammatory hyperpigmentation (PIHP) is a frequently encountered problem in many cosmetic procedures. The treatment of PIHP is difficult and remains a challenge. Objective. To treat a patient who developed multiple hyperpigmented macules on her thighs due to sun exposure after treatment of unwanted hair using a normal-mode ruby pulse laser. Methods. The patient was treated daily with tretinoin (Retin A) 0.1% cream, triamcinolone 0.1% cream, and hydroquinone 4% cream with sunscreen (Solaquin forte), and was to avoid sun exposure. Several sites received monthly treatment of 40% trichloroacetic acid (TCA). The degree of clinical improvement of the hyperpigmentation was assessed by both the physician and the patient. Results. Cosmetic results were fair. The amount of hair in her thighs was reduced but the PIHP responded only slightly to therapy. Conclusion. To our knowledge this is the first case of solar-induced PIHP following laser hair removal. The treatment of PIHP is difficult because there are few therapeutic options that are consistently successful. Avoidance of exposure to ultraviolet light should be emphasized to all patients prior to laser therapy. We demonstrated that serial TCA peels provided an additional benefit compared to medical treatment.
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A small, light-weight, low-energy, and low-cost IPL system designed for home use (Silk'n; HomeSkinovations, Kfar, Saba, Israel) was tested for efficacy and safety on 34 test individuals and 92 sites. Each of the patients underwent informed consent and performed self-treatment at the clinic supervised by an experienced laser hair removal nurse. The pre- and post-treatment hair counts were performed and the reduction counts were analyzed by a blinded observer.
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Suitably brief pulses of selectively absorbed optical radiation can cause selective damage to pigmented structures, cells, and organelles in vivo. Precise aiming is unnecessary in this unique form of radiation injury because inherent optical and thermal properties provide target selectivity. A simple, predictive model is presented. Selective damage to cutaneous microvessels and to melanosomes within melanocytes is shown after 577-nanometer (3 x 10(-7) second) and 351-nanometer (2 x 10(-8) second) pulses, respectively. Hemodynamic, histological, and ultrastructural responses are discussed.
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Lasers and light sources are now used worldwide for permanent or prolonged hair removal. Patients now prefer lasers and light sources for hair removal because of their noninvasiveness and fewer reported side effects. To study and report on leukotrichia that developed following application of intense pulsed light (IPL). From February 9, 2001 to February 14, 2002 a total of 821 patients were treated for unwanted hair. The system used was a noncoherent IPL system, with a 650 nm flashlamp filter; the parameters used varied with different Fitzpatrick skin types. The patients were treated monthly, with the rate of hair loss, measured by hair counts, and possible side effects recorded. Twenty-nine of 821 patients treated developed leukotrichia. Thirteen patients had no white or gray hairs before IPL therapy; the remaining 16 patients, who had few white hairs before treatment reported accelerated development of new white hairs starting after the first or second IPL therapy. Restoration of hair color occurred in 9 patients and the remaining 20 patients had no improvement or worsening of the condition within the next 2-6 months. Temporary or permanent leukotrichia may develop following IPL and laser hair removal therapy. This finding may be explained by the difference in the thermal relaxation times of melanocytes and germinative cells. The light absorbed and the heat produced by melanin may be sufficient enough to destroy or impair the function of melanocytes but insufficient to damage the hair follicle cells.
Article
Intense pulsed light (IPL) has been successfully used as an efficient hair removal system; however, possible side-effects have been not specifically addressed in the literature. To assess all possible side-effects after IPL hair removal in a series of 49 females with facial hirsutism during a total of 390 treatment sessions of IPL photodepilation. Immediate post-treatment clinical, photography evaluation, and a two-month post-treatment questionnaire were done in 49 females with facial hirsutism submitted to photodepilation with an IPL source (EpiLight trade mark, ESC, Israel). Side-effects observed were: transient erythema (n = 30), late evanescent erythema (n = 3), mild pain (n = 43), moderate pain (n = 6), crust formation (n = 9), superficial burning (n = 1), isolated vesicles (n = 3), transient hyperpigmentation (n = 8), transient hypopigmentation (n = 1), paradoxical effect (n = 5), persistent local heat sensation (n = 1), and minimal scar (n = 1). Even though common, most side-effects secondary to IPL photodepilation are mild and transient. Permanent side-effects such as scars are unlikely but they may occur. Growth of new, fine and dark hair may be seen in untreated areas in close proximity to the treatment area, especially in the neck, a side-effect that is reported for the first time in the literature.