DOI: 10.1111/j.1610-0387.2011.07764.

x Review 103

Medical devices in dermatology: topical semi-solid

formulations for the treatment of skin diseases
Hans Christian Korting, Claudia Schöllmann
Department of Dermatology and Allergology, Ludwig Maximilian University, Munich, Germany

JDDG; 2012 • 10:103–109 Submitted: 12.4.2011 | Accepted: 28.6.2011

Keywords Summary
• medical device In recent years, topically applied semi-solid formulations certified as medicals
• atopic dermatitis devices and not as topical drugs are increasingly used for the treatment of skin
• actinic keratosis diseases. Medical devices primarily unfold their therapeutic effect by physical
• head lice means, not by pharmacological, immunological or metabolic means.
• scars Intensified placing of medical devices on the dermatological market may at
• radiation-induced dermatitis least partly be explained by a less complex marketing authorization process
compared to topical drugs. If the requirements are fulfilled to certify a product
as a medical device the opportunity will be offered to quickly introduce inno-
vations onto the market and propagate them. A variety of evidence-based
medical devices for several dermatological indications are presented here.

Topical drugs, cosmetics and medical
devices: definitions and legal basis
From a legal standpoint there are three
possibilities in dermatology to apply
semi-solid formulations to the skin – in
the form of topical drugs, cosmetics or
medical devices. What lawmakers under-
stand under the term drugs, cosmetics or
medical devices is defined in the wording
of the law. The corresponding defini-
tions for drugs are found in the Drug
Law (Arzneimittelgesetz, AMG), for cos-
metics in the national Cosmetics Guide-
line 76/778 /EWG or after 11 July 2013
in the binding EU Cosmetics Directive
(VO (EG) No. 1223/2009) and for
medical devices in the Medicinal Prod-
ucts Act (MPA).
In a simplified manner
• drugs are defined as substances or sub-
stance mixtures that are administered
to heal or prevent diseases or restore,
correct or affect physiological func-
tions by pharmacological, immuno-
logical or metabolic means (Guideline
2001/83/EG),
• cosmetics are defined as substances or
substance mixtures that are intended to
be applied externally to parts of the hu-
man body or teeth and mucous mem-
branes of the oral cavity – for the sole
or predominant purpose to cleanse, to
perfume, to change their appearance,
to protect, to keep them in good con-
dition or to influence body odor (Cos-
metics Guideline 76/778 /EWG and
VO (EG) No. 1223/2009),
• medical devices are defined as objects or
substances that serve the recognition,
prevention, monitoring, treatment and
alleviation of diseases that achieve this
purpose (“intended main effect”) by
physical means, not by pharmacologi-
cal/ immunological means or through
metabolic effects [1]. The physical ef-
fects of medical devices may, nonethe-
less, be supported by pharmacological,
immunological or metabolic effects [1].
In addition to these definitions orientated
on the function of the respective product,
topical drugs, cosmetics and medical de-
vices also differ with respect to their legal
basis – especially with regard to introduc-
tion onto the market and propagation.
Drugs are regulated by the Drug Law
(Arzneimittelgesetz, AMG), cosmetic
products by the national Cosmetics
Guideline (or after 2013 the EU Cosmet-
ics Directive (VO) (EG) No. 1223/2009)
and the superordinate Food and
Feed Code (Lebensmittel-, Bedarfsge-
genstände- und Futtermittelgesetzbuch,
LFGB) [2, 3] and medical devices in the
Medicinal Products Act (MPA). Bringing
drugs onto the market is distinctly more
complicated than cosmetics or medical
devices, as a comprehensive licensing pro-
cedure must be passed through.
Within the framework of the licensing
procedure for drugs the respective phar-
maceutical manufacturer must provide
evidence of efficacy, safety and quality of
the drug to the drug authority responsible
in a licensing application. The documen-
tation required with the application is reg-
ulated in detail [4]. On the basis of the
documentation the authority evaluates if
the drug has a favorable benefit-risk ratio
for the indication applied for – a prerequi-
site for licensing. Only after the license is
approved may the drug be brought onto
the market and used for the licensed indi-
cations. The purpose of this complicated
regulation is to protect the population
from harmful or ineffective drugs.
Examinations are also foreseen for the
licensing of a medical device, but these

© The Author • Journal compilation © Blackwell Verlag GmbH, Berlin • JDDG • 1610-0379/2012/1002 JDDG | 2 ˙2012 (Band 10)
104 Review
are substantially less complicated than in
drug licensing. In principle, medical
devices must fulfill the fundamental
requirements of the Medicinal Products
Act with respect to safety, proper func-
tioning and harmlessness to health; this
must be documented in writing in what
is termed the conformity evaluation (a
certification process). This is the prereq-
uisite that medical devices can receive
the CE registration and thus be brought
onto the market in the European eco-
nomic area. The fundamental require-
ments are spelled out in European guide-
lines. Appendix I of the Guideline
93/42/EWG (other medical devices) is
applicable to semi-solid formulations
used in dermatology. The guideline also
establishes into which of four possible
risk classes the product is classified using
criteria such as duration of use or degree
of invasiveness. Semi-solid formulations
for topical application to treat skin dis-
eases that are marketed as medical de-
vices are usually assigned to class IIa.
This denotes that the products do have a
certain risk in use, the degree of invasive-
ness is moderate and that the uninter-
rupted or repeated use of the product is
only on a short-term basis (ⱕ30 days).
In modern dermatology a trend can be
observed towards increased use of semi-
solid formulations that are not licensed
as drugs. On the one hand these are cos-
metics whose composition increasingly is
in accord with the concept of evidence-
based cosmetics [5–7] and on the other
formulations marketed as medical de-
vices. Products do exist in a border zone
where classification is not always easy.
Sunscreens, for example, are typically
cosmetics and therefore according to def-
inition should not protect from diseases,
but – on the other hand – are intended
to prevent the disease sunburn (classified
according to ICD-10). Manufacturers
that have a particularly reliable product
with good scientific documentation
could in the individual case consider li-
censing and marketing their sunscreen as
a medical device, if the requirements of
the Medicinal Products Act which are
higher in comparison to the national
Cosmetics Guideline 76/788 /EWG or
the EU Cosmetics Directive are fulfilled.
The increased marketing of medical de-
vices for dermatological purposes must
surely be viewed from the aspect of easier
licensing in comparison to drugs. If the
requirements to license a product as a
JDDG | 2 ˙2012 (Band 10)
medical device are fulfilled, the opportu-
nity will be offered to introduce innova-
tions particularly quickly onto the mar-
ket and propagate them [8]. In individual
cases – namely when the additional bene-
fit of the product is particularly promi-
nent – licensing as a topical drug should
be considered. In no case should the fact
that a product is registered as a medical
device and not a topical drug lead to the
conclusion of lower medical value. The
health-promoting effects of modern
medical devices in dermatology are also
increasingly orientated towards the de-
mands of evidence-based medicine.
In the following examples of already estab-
lished medical devices that are employed
as semi-solid formulations for topical
application to the skin for various derma-
tological indications will be presented.
Atopic dermatitis
Atopic dermatitis (AD) is a complex,
chronic inflammatory skin disease pref-
erentially affecting children and adoles-
cents (prevalence 10–20 %), less fre-
quently adults (< 10 %) [9]. AD reduces
quality of life of patients and their fami-
lies to a high degree [9]. The disease,
which often represents the first manifesta-
tion of atopy in childhood, is characterized
by xerosis, pruritus and erythematous
lesions associated with transepidermal
water loss [11]. Patients with AD are fur-
thermore predisposed to colonization
and infection of the skin by various mi-
croorganisms, especially Staphylococcus
aureus and Herpes simplex virus [12].
New insights into the pathophysiology
of the disease point to an important role
of structural abnormalities in the epider-
mis that are associated with an immuno-
logical dysregulation [12].
At present one semi-solid formulation is
licensed as a medical device for topical
application that is employed in the man-
agement of AD whose efficacy and toler-
ability is proven. This is a nonsteroidal
multicomponent product (Atopiclair®;
Sinclair Pharma, Frankfurt/Main, Ger-
many) that is certified as a medical de-
vice for reduction of signs and symptoms
of AD and contact dermatitis. The clini-
cally studied multicomponent treatment
is distinguished from other topical
preparations with only one active ingre-
dient such as a corticosteroid or a cal-
cineurin inhibitor that dominate the
market at the present time. The prepara-
tion, an oil-in-water emulsion, contains
© The Author • Journal compilation © Blackwell Verlag GmbH, Berlin • JDDG • 1610-0379/2012/1002
Medical devices in dermatology
as important components Vitis vinifera
(a natural extract of grapevine), vitamins
C and E, telmesteine, hyaluronic acid,
glycyrrhizin and Butyrospermum parkii
(shea butter). The action of the multi-
component product is explained by hy-
dration of the inflamed tissue as well as
improvement of skin integrity and the
barrier function of the skin, which in the
end contribute to a reduction of pruritus
and the burning sensation [9].
Four multicenter, randomized, vehicle-
controlled studies – two of which were
performed on pediatric patients – verify
tolerability and efficacy of the product
on a total of 450 patients with mild to
moderate AD [13–16]. All displayed dis-
tinct improvement of signs and symp-
toms of AD after 22 days of treatment
(three times daily) with the product as
opposed to vehicle (Table 1), with the re-
duction of pruritus being particularly
striking in all studies [9, 16] (Figure 1).
Treatment also proved to be well-toler-
ated. Side effects such as contact der-
matitis, burning sensation, erythema and
stinging sensation after application were
rare and not more frequent than after ap-
plication of the vehicle [9]. Atopiclair® is
therefore an evidence-based treatment
option for mild to moderate AD in chil-
dren and adults.
X-ray- or radiation-induced dermatitis
Radiotherapy is an important treatment
option in cancer therapy. Up to 95 % of
patients receiving radiotherapy of the
thorax develop a dose-dependent skin re-
action in the form of radiation-induced
dermatitis [17] that can range from mild
erythema up to moist desquamation and
at times may be dose-limiting.
Two smaller randomized, double-blind,
vehicle-controlled studies on a total of
60 patients demonstrated the tolerability
and efficacy of the nonsteroidal medical
device Xclair® (Sinclair Pharma, Frankfurt/
Main, Germany) which, in addition to
hyaluronic acid, contains the components
Butyrospermum parkii (shea butter),
glycyrrhicin, allantoin, bisabolol, Vitis
vinifera (natural extract of grapevine),
telmesteine as well as the vitamins C and
E. In the one study 40 breast cancer pa-
tients treated with radiotherapy received
during radiotherapy and for the follow-
ing three weeks either the above-
mentioned medical device three times
daily or the respective vehicle, a water-
in-oil formulation. The medical device
Medical devices in dermatology Review 105

Table 1: Change of EASI (Eczema Area and Severity Index) score after 22 days of application of the nonsteroidal
multicomponent product Atopiclair®.

Improvement in the verum Improvement in the vehicle

group( mean ± standard group (mean ± standard p-value
deviation) deviation)
Abramovits et al., 2008 [13], p < 0.0001
–3.82 ± 3.44 –0.15 ± 4.78
(218 adult patients) (ANCOVA)
Belloni et al., 2005 [14], (30 p = 0.024 (Wilcoxon
–4.0 ± 3.9 –0.7 ± 2.6
adolescent and adult patients) rank sum test)
Patrizi et al., 2008 [15],
–3.70 ± 3.30 –1.38 ± 3.13 p < 0.05 (Tukey’s test)
(60 pediatric patients)
Boguniewicz et al., 2008 [16],
–5.15 ± 7.24 0.84 ± 3.52 p < 0.0001 (t-Test)
(142 pediatric patients)

nonetheless, needed to confirm these

data.

Figure 1: Change of pruritus in pediatric patients with AD after treatment with the nonsteroidal
multicomponent product Atopiclair® or vehicle without key ingredients assessed by means of a Visual
Analogue Scale (VAS); from [16], modified.
demonstrated superiority with respect to
maximum severity of skin toxicity (p <
0.0001), the burning sensation in the ir-
radiated field (p = 0.039) and desquama-
tion (p = 0.02), while the tolerability of
both formulations was equally good [18].
Another study on 20 breast cancer pa-
tients delivered comparable results [19].
Seborrheic dermatitis
The term seborrheic dermatitis (SD) de-
notes a skin disease that manifests partic-
ularly on the scalp and in the face and is
usually associated with scaling. Besides
topically applied drugs such as antifun-
gal agents or the calcineurin inhibitors
pimecrolimus or tacrolimus, a topically
applied medical device (Sebclair®; Sin-
clair Pharma, Frankfurt/Main, Germany)
is capable of reducing symptoms of
SD. At least the data of a randomized,
double-blind, controlled pilot study on
60 SD patients suggest this. The patients
had applied three times daily over four
weeks either a semi-solid formulation
with various ingredients such as Butyros-
permum parkii (shea butter), acitrutol,
allantoin, bisabolol, the vitamins C and
E, Aglycera complex and piroctone
olamine (Sebclair®; n = 40) or the re-
spective vehicle (n = 20). In the group
that had received the multicomponent
product therapy was distinctly more suc-
cessful than in the vehicle group (68 vs.
11 %; p < 0.0001) [20]. Erythema and
pruritus declined to a distinctly greater
degree. Tolerability of both trial products
was equally good. Further studies are,
Actinic keratosis
Actinic keratoses (AK) are defined as
scaly, often erythematous lesions in-
duced by many year of sun exposure.
They are found especially on the “sun
terraces” of the skin: the forehead,
cheeks, forearm, dorsa of hands and the
décolleté. AK are the most common neo-
plasias in the fair-skinned population
and belong to the group of non-
melanoma skin cancer. They are defined
as squamous cell carcinomas in situ [21].
Due to their tendency to transform into
invasive squamous cell carcinomas, AK
require early treatment. Clinically, AK
are characterized by scaling, hyperkera-
totic, partially erythematous, usually ex-
tensive lesions on sun-exposed skin sites
[22], associated with inflammatory reac-
tions, altered pigmentation and the typi-
cal sings of prematurely aged skin [23].
UV radiation is considered the main risk
factor for the development of non-
melanoma skin cancer.
Strategies for prevention of these epithe-
lial cutaneous lesions and for effective
treatment of already established AK are
therefore of great significance to public
health [24]. For the treatment of AK and
thus also for prevention of squamous cell
carcinomas physical methods such as
cryotherapy, curettage, excision and laser
therapy as well as various medications are
available today [25]. Besides therapy for
already existing AK, the prevention of
these lesions is of great importance – also
and especially for patients with already
chronically sun-damaged skin. Avoidance

© The Author • Journal compilation © Blackwell Verlag GmbH, Berlin • JDDG • 1610-0379/2012/1002 JDDG | 2 ˙2012 (Band 10)
106 Review
of sun exposure and the use of suitable
sunscreens are the decisive aspects in
order to prevent the development of (fur-
ther) AK and the transformation of AK
into invasive carcinomas. In this context
a liposomal sunscreen is evidence-based
and certified as a medical device (Day-
long actinica® with the filters bis-ethyl-
hexyloxyphenol-methoxyphenyltriazine,
ethylhexyl-triazone, isoamyl-p-methoxycin-
namate, ethylhexyl-methoxycinnamate,
butyl-methoxydibenzoylmethane; Spirig
Pharma, Egerkingen, Switzerland); its
efficacy was demonstrated in the high-
risk group of patients with organ trans-
plants, who due to immunosuppressive
agents are particularly in danger of de-
veloping AK and non-melanoma skin
cancer [26].
In a prospective case-control study on
120 patients with organ transplants
(40 heart, 40 kidney, 40 liver) were in-
cluded and were informed about sun
protection measures; 60 of the patients
additionally applied a once daily dose of
2 mg/m2of a liposomal sunscreen (Day-
long actinica®) with a sun protection fac-
tor > 50 to the head, nape of the neck,
upper arms and hands. After 24 months
the number of AK had declined by 102
in the medical device group, while in the
control group 82 new AKs had devel-
oped (p < 0.01) [26]. Further, in the
control group eight new squamous cell
carcinomas had developed but not one
in the sun protection group (p < 0.01).
Basal cell carcinomas also developed less
frequently in the medical device group
(n = 6) than in the control group (n = 9),
even though the difference was not sig-
nificant. On the basis of the existing data
the authors recommend that all persons
with an increased skin cancer risk – im-
munocompetent as well as immunosup-
pressed – use an effective sunscreen to
prevent the further development of AK
and the malignant transformation of al-
ready present or newly appearing AK
into invasive carcinomas [26]. It must be
noted in this connection that Daylong
actinica® is not only the first medical de-
vice of the type semi-solid formulation
for topical use on the skin licensed for
prevention of skin cancer, but the first
product of its kind for external use on
the skin at all.
Pediculosis capitis
Head lice are widespread – in developing
nations just as in industrialized nations.
JDDG | 2 ˙2012 (Band 10)
The incidence of head lice in Germany is
increasing in recent years and is higher
today than in the 1960s [27]. Mainly
children are affected. The prevalence of
pediculosis capitis in industrialized na-
tions is estimated to be 1 to 3 % [28].
Transmission occurs predominantly by
direct hair contact, while the risk of in-
festation via caps, cuddling toys or up-
holstered furniture is negligible. Head
lice are 2 to 3.5 mm large insects that
usually live on the human scalp and are
dependent on a blood meal every two to
three hours.
Fertilized females lay up to ten eggs daily
that are glued to the hair in the immedi-
ate vicinity to the scalp with a substance
insoluble in water – surrounded by a cas-
ing (nit). After seven to ten days young
lice, also termed larvae and nymphs,
hatch. After several molts within eight to
nine days the nymphs become sexually
mature and are infectious as adults [29].
Two to three days after mating the fertil-
ized females are ready to lay eggs; the en-
tire reproduction cycle takes 14 to
28 days. The main symptom of lead lice
infestation is strong pruritus, usually ac-
companied by erythema. Pruritus is
elicited by the human immune reaction
towards saliva enzymes of the louse that
enter the blood during the blood meal.
Excoriations caused by scratching may
undergo bacterial superinfection.
For medical topical treatment of pedicu-
losis capitis various chemical pediculi-
cides, usually on the basis of neurotoxic
insecticides such as natural pyrethroids
or synthetic pyrethroid derivatives (per-
methrin, allethrin) are available that are
effective against vital lice and nits. Nev-
ertheless, there exists the problem of in-
creasing resistance to all conventional
pediculicides licensed in Germany [28].
Further these preparations which burn
on scratch-induced erosions are often
only poorly accepted by children [28].
Against this background a strategy has
developed as a therapeutic alternative
based on purely physical means – thus in
the sense of a classical medical device –
against the lice. This is achieved with the
help of synthetic silicone oils, termed
dimethicones. Due to its special creeping
and spreading properties dimethicone
blocks the respiratory openings (tra-
cheae) of the lice/nits and thus suffocates
them [30]. This purely physical mecha-
nism of action rules out the development
of resistance and can be employed suc-
© The Author • Journal compilation © Blackwell Verlag GmbH, Berlin • JDDG • 1610-0379/2012/1002
Medical devices in dermatology
cessfully even in cases of proven resist-
ance towards chemical pediculicides
[30]. Dimethicone is well-tolerated and
suitable for children over two years.
Particularly effective is the combination
of two dimethicones that differ with
respect to their viscosity – as contained
in the medical device NYDA® (Pohl-
Boskamp, Hohenlockstedt, Germany).
The thin, volatile component enters the
openings of the tracheae particularly
well, while the more viscous, less volatile
component after evaporation of the
volatile component and the resulting
thickening provides the final cut-off of
oxygen. In vitro studies demonstrate a
pediculicide and ovicide effect of the 2-
phase dimethicone, also in comparison
to other common and well-known prod-
ucts. Already after five minutes and at all
further examination time points, the lice
display no relevant signs of life any more,
what no other comparative substance or
preparation (0.5 % permethrin, 4 %
dimethicone, soy-coconut oil, 0.3 %
pyrethrum extract) achieved [31, 32].
Also the killing effect of the medical de-
vice was superior to the comparative sub-
stances: After an incubation time of just
one hour the hatching ratio of young
eggs was 0 % and of ripe eggs 3.9 %,
while the hatching rate with the compar-
ative substances was at least 35 % [33].
Additionally the 2-phase dimethicone
was tested in a controlled, randomized,
clinical comparative study against a 1 %
permethrin solution. For this purpose
145 children aged between 5 and
15 years from a Brazilian region with a
high prevalence of head lice (without
known permethrin resistance) were
treated topically with the test prepara-
tion in a randomized manner on day 1
and day 8 (dimethicone group: n = 73;
permethrin group: n = 72). Combing be-
fore the study was intentionally avoided;
on days 2 and 9 the small patients were
combed-out wet. Results: with respect to
the healing rate on days 2 and 9, defined
as the complete lack of active and mobile
lice, the 2-phase dimethicone was supe-
rior to the permethrin solution [34]
(Table 2). Further, the product was well-
tolerated and with respect to cosmetic
acceptability was clearly judged better
(p = 0.01).
Present data suggest that the 2-phae
dimethicone licensed as a medical device
and reimbursable for children up to the
12th birthday is at least equivalent to if
Medical devices in dermatology Review 107

mal keratinocytes to dermal fibroblasts

Table 2: Pediculosis capitis: healing rates after treatment with the 2-phase and to an inhibition of fibroblast prolif-
dimethicone NYDA® (n = 73) compared to permethrin solution 1 % (n = 72) eration and reduced collagen synthesis
in a controlled clinical trial; [from 34]. [36].
A prospective study over 90 days on a to-
Dimethicone group Permethrin group p-value tal of 30 patients compared the efficacy
Healed/ total Healed/ total of a self-drying silicone gel (Kelo-cote®,
% % formerly Dermatix®; Sinclair Pharma,
number number
Frankfurt/Main, Germany) licensed as a
Mild to moderate involvementa medical device for prevention and treat-
• Day 2 37/38 97.4 % 23/31 74.2 % 0.004 ment of hypertrophic scars and keloids
following surgery, accidents or other
• Day 7 32/38 84.2 % 23/31 74.2 % 0.3 trauma with that of a classical silicone
• Day 9 36/37 97.3 % 25/31 80.6 % 0.02 sheet and a combined treatment (gel in
b
the morning, sheet in the evening). The
Severe involvement scars treated with the silicone gel had a
• Day 2 32/35 91.4 % 25/41 61.0 % 0.002 distinctly lower height than those treated
with the sheet on day 90 (0.79 vs.
• Day 7 15/35 42.9 % 20/41 48.8 % 0.6
1.39 mm, not significant) [37]. Further,
• Day 9 34/35 97.1 % 23/40 57.5 % < 0.0001 the mean skin erythema score during
a treatment declined in the silicone gel
<5 active lice at the start of the study
group by 4.26 units, in the silicone sheet
b
ⱖ5 active lice at the start of the study
group in contrast only by 2.52 (p <
0.01). Combination treatment brought
no further advantages. These data were
fundamentally confirmed by a larger
prospective randomized parallel group
study on 160 patients with fresh surgical
scars [38]. The patients who had been
treated with the silicone gel for six
months developed distinctly less and also
less extensive scars than untreated pa-
tients (Figure 2).
The silicone gel Dermatix® ultra presently
on the market differs considerably in the
composition from the former Dermatix®
and present Kelo-cote®.

Conclusions
In dermatology increasingly semi-solid
formulations for topical application are
being brought onto the market for the
Figure 2: Evaluation of scar quality according to morphological features after six months of treatment treatment of certain, especially inflam-
of 80 patients with fresh surgical scars with a self-drying silicone gel (Dermatix®, today Kelo-cote®) matory, skin diseases that are licensed as
compared to untreated controls (n = 80). Scars were classified as: grade 1: normal skin; grade 2: mild-
ly hypertrophic; grade 3: elevated (hard, dark pink to dark red); grade 4: very elevated (very hard, red
medical devices and not as topical drugs.
to brown color, outside wound margins). The difference between the scar quality in treated and This is surely also a result of the less com-
untreated patients was statistically significant (p < 0,001); from [38]. plex marketing authorization process in
comparison to drugs allowing for a
particularly rapid introduction of inno-
not even superior to the chemical pedi- Silicone gels according to clinical studies vations. A requirement for licensing a
culicides licensed for the same indication and clinical experience are possibly formulation as a medical device is that its
as topical drugs with respect to efficacy equally effective as traditional silicone health-promoting effects be achieved by
and possibly also tolerability. sheets, bur easier to handle [36]. The physical means. The treatment and
mechanism of action of silicone is not prevention of skin diseases is today orien-
Hypertrophic scars and keloids yet completely understood, but probably tated towards the principles of evidence-
For hypertrophic scars and keloids inter- involves hydration of the stratum based medicine. For certain medical
national experts recommend in addition corneum as a result of occlusion together devices of the type semi-solid formulations
to intralesional corticosteroids also with reduced transepidermal water loss just as for topical agents an undoubtedly
silicones as products of first choice for are involved [36]. This leads to cytokine- favorable benefit-risk ratio can be
treatment and prevention of scars [35]. based signal transmission from epider- presumed. Such medical devices thus

© The Author • Journal compilation © Blackwell Verlag GmbH, Berlin • JDDG • 1610-0379/2012/1002 JDDG | 2 ˙2012 (Band 10)
108 Review
represent valid alternatives and substan-
tial supplements to the therapeutic
armamentarium in dermatology. Simply
the fact that a product is licensed as a
medical device and not a topical drug
does not indicate less medical value.
Conflicts of interest
The development of this manuscript was
financially supported by a grant to
Dr. Schöllmann by Sinclair Pharma,
Frankfurt/Main, Germany. The contents
of the publication were not influenced
by the company. <<<
Correspondence to
Prof. Dr. Hans Christian Korting
Department of Dermatology and
Allergology
Ludwig Maximilian University
Frauenlobstrasse 9–11
D-80337 Munich, Germany
Tel.: +49-89-5160-6010
E-mail: h.c.korting@lrz.uni-muenchen.de
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