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Method Review
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Introduction
2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Experimental Dermatology, 2015, 24, 561566
The Skin
Skin health is influenced by numerous factors such as lifestyle,
environment (chronic sun exposure and UV radiation), genetics,
hormones and nutrition (12). Ageing of the skin is a multifactorial
phenomenon which combines the cumulative effects of chronic
exposure to the elements, primarily UV radiation, as well as the
degradation of elastin fibres and marked collagen reduction causing wrinkle development (13). Facial scarring, arising for a number of reasons such as depigmentation, acne or burn-related scars
and the formation of large pores (14,15), is a distressing phenomenon encountered by many people. In addition, intervention treatments for stretch marks undergo continuous review (16). One of
the most common skin diseases which results in scaring is acne
vulgaris, a potentially psychologically distressing condition, the
pathogenesis of which is underpinned by active inflammation
leading to damage to the elastic support structures beneath the
skin surface and resulting in the development of atrophic scars
(15,17). A recently published paper concisely details variability in
acne scarring and documents different treatment approaches,
including needling (18). Ablative methods such as laser resurfacing
or dermabrasion are currently available for the treatment of
scarred and ageing skin but are invariably associated with significant post-operative changes in the skin and require lengthy healing times. In considering this, it was highlighted by Aust et al.
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McCrudden et al.
(19) that there was a need for less invasive treatment options to
combat these conditions. A thorough 2014 review charts the wide
range of skin resurfacing therapies currently available to clinicians,
in addition to innovative therapies under development (20).
Microneedling and subsequently MN devices are examples of such
innovative therapies.
Stratum corneum
Microneedle
Viable epidermis
Dermis
Arteriole
Venule
Dermal nerve
(a) Hollow
(b) Coated
(c) Solid
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Approved MN devices
Dermaroller
2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Experimental Dermatology, 2015, 24, 561566
grade solid steel MNs, projecting from a cylindrical roller (Fig. 3a)
(3335). The rolling mechanism is applied directly over the skin,
vertically, horizontally and diagonally. There are 24 circular arrays
of eight needles each located on the roller (total 192 needles)
(3436) (Fig. 3a), and the heights of the needles are specific to the
nature of the treatment being employed (7). Home Dermarollers
consist of the Home Roller C 8 (a single needle which is depicted
in Fig. 3b) and the Beauty Mouse. The cosmetic, C 8 model has
needles ranging between 130 and 200 lm in height (Fig. 3b), with
a penetration diameter of 70 lm (34). Another device intended
for home use is the Beauty Mouse, which incorporates 3 Dermarollers with a total of 480 needles and has been developed to
ensure coverage of larger skin surface areas, such as the arms, legs
and buttocks for the treatment of stomach or thigh stretch marks
and cellulite (37). The medical models, CIT 8 and MF 8, are
intended for use by trained professionals only. The CIT 8 has needle heights of 500 lm, and the MF 8, heights of up to 1500 lm
(Fig. 3c and d) (36). A number of other companies, for example,
Hansderma and White Lotus, have marketed products with similar
functions (38,39). Despite the fact that MN devices are often categorised into home and medical use in product literature, they are
available for purchase by any individual online from a multitude
of commercial websites. With no restriction on purchasing of
these products, it is clearly evident that there is potential for abuse
and misuse of these devices.
PCI technology has subsequently evolved with the emergence of
miniature versions of the Dermaroller, termed DermastampsTM
onto the UK market (40). These are sterile medical devices with
(a)
Handle
Roller Disc
MN
(d)
(c)
(b)
Dermapen
Advantages of microneedling
One of the most important advantages of these MN devices is in
overcoming the use of traditional ablative methodologies. Ablative
methods including dermabrasion, chemical peels, collagen injections, cortisone-like injections, cryosurgery and laser resurfacing
are, by their nature, extremely physically disruptive to the targeted
epidermis and superficial dermis (43). In ablative methodologies
such as these, undesired post-operative changes in the skin can
result in significant healing times. As destruction, rather than disruption, of the epidermis initiates an inflammatory response that
stimulates fibroblasts to produce thick branches of scar collagen
(44), skin has been shown to become more sensitive to photodamage and one study has stated that a side effect of such treatment may be the development of dyschromias, a common skin
disorder whereby there is a marked alteration in normal skin pigmentation, resulting in discolouration of the skin, hair and nails
(31). In contrast, microneedling, if limited to breaching the SC
with needles of appropriate heights, would negate the risks and
negative side effects often seen with invasive ablative approaches.
Areas of debate
(e)
(f)
2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Experimental Dermatology, 2015, 24, 561566
Public perception
The future commercial and clinical success of MN devices will
undoubtedly depend not only upon their ability to fulfil a designated function, but also on their acceptability by both patients
and healthcare professionals (48). To this end, the perception of
MN was documented in an informative study carried out by the
Birchall group (49), in addition to a recent pilot study conducted
by the Donnelly research team (50). In both instances, study participants acknowledged the potential benefits of a MN delivery
system with 80% of the participants having a strongly positive
perception of the MN devices used in the study (50). Potentially
detrimental to the impact of such studies however, are reports
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McCrudden et al.
such as that published in the Daily Mail in 2009 which stated that
the Dermaroller, specifically, resembled a miniature medieval
instrument of torture (45). Despite this poor description of the
device, the article concluded that the use of the Dermaroller
resulted in signs of improved skin appearance: smoother and much
fresher, as the skin takes on a new vitality and looks brighter as well
as firmer (45). Media reports such as this reinforce the importance of clear message dissemination to the general public about
these devices and their uses so that their reputation may not be
unnecessarily harmed.
Patient safety
The potential long-term effects of MN application or indeed
repeated MN application on skin is currently unknown. As with
any novel technology, inappropriate use could cause problems.
With specific reference to cosmetic MN devices, three cases of
allergic granulomatous and systemic hypersensitivity in female
patients, following application of a non-sterile topical product and
subsequent MN treatment, have been reported (46). Worth noting, however, is that, in each case, medical supervision was absent.
In all three cases, the deleterious side effects witnessed were determined to have been due to the inappropriate intra-dermal tattooing of the skin with antigenic topical products. The combined use
of these topical products with MN application is unlicensed, and
so the artificially enhanced delivery of these products to the dermis in this report resulted in the hypersensitivity reactions
observed. In all cases, full or partial recovery was achieved following corticosteroid or tetracycline treatments (46). These cases
highlight the need for caution with regard to inappropriate use of
topical medicines in combination with enhanced transdermal
delivery methods. MN application should only be used in conjunction with fully licensed and tested therapeutics or cosmetics,
designed for this intended purpose.
The question of whether MN devices, for use in cosmetic applications, should be terminally sterilised has also been brought to
the fore. This question must be addressed in line with the recommendations of regulatory bodies, as inappropriate use of microneedling devices could potentially lead to the early, unwarranted
rejection of the devices. An example of one such damaging report,
which involved the inappropriate use of non-adequately sterilised
MN devices between patients, was published in the Daily Mail
in August 2011 (47). Regardless of how MN devices are classified
by the pharmaceutical and cosmeceutical industries, for example
drug delivery systems, consumer products or medical devices, they
are not equivalent to conventional transdermal patches, in that
they do not simply adhere to the skin surface (48). Considered
to be more akin to a conventional hypodermic injection, this
may mean that they will be required to be terminally sterilised.
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-glucuronic acid
N-acetyl glucosamine
N-acetyl glucosamine
2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd
Experimental Dermatology, 2015, 24, 561566
New advancements
Summary
The exploitation of MN technologies in facilitating efficient delivery of cosmeceutics is actively advancing with many interesting
studies having been published within the past 2 years. For example, a study carried out in mice detailed the in vivo efficacy of eflornithine cream at inhibiting hair growth, following pretreatment
of mouse skin with MN (67). The authors concluded that, with
reference to patients suffering facial hirsutism, this approach represents a potentially viable means of increasing eflornithines ability to inhibit hair growth. Conversely, MNs have also been used
in combination with topical products, such as minoxidil, to stimulate hair regrowth. Following on from pilot studies carried out in
mice (68,69), a 2013 study evaluated the influence of microneedling and minoxidil topical treatment, on human subjects suffering with androgenetic alopecia (AGA) (70). A Dermaroller with
needle heights of 1.5 mm was rolled over the shaven scalp in
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Acknowledgements
Conflict of interest
MMcC and EMcA researched and wrote the paper. AJC and PGV prepared
the figures. TRS and RFD conceived and critiqued the paper.
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