SEBOCLEARTM-DB

Normalises the Skin

Content

03 The appearance of skin

04 Oily skin
05 The formation of sebum
06 Active ingredients
11 Treatment concept and efficacy studies
12 The reduction of pustules and comedos (in-vivo study)
13 Test formulations for the efficacy studies
15 Bibliography
NORMALISES THE SKIN
The appearance
of skin
Whether skin tends to be dry, oily or shiny depends on the
balance between the individual components within the
skin’s composition. The sebum cutaneum forms the main
component of the lipids in the protective cover layer. By def-
inition, the sebum cutaneum is described as being viscose
skin oil which is produced and secreted by sebaceous gland
cells and controlled by hormones (testosterone and proges-
terone stimulate production, estrogens reduce this).
Starting with the onset of puberty, the production of sex
hormones has an effect on the sebaceous glands.
This is why the sebaceous glands are especially active during
the growth stage of most young people. The most suscepti-
ble areas for this are the chin, nose and forehead. The for-
mation of callous horn is stimulated at the same time so that
3
nt
ia
pl
m
co
the increasing amount of horn cells get stuck during the ex-
cretion process. This is the reason why blockage of the seba-
ceous gland is the result. Skin often reacts to this sort of
condition by becoming inflamed. The arrival and collection
of bacteria intensifies the inflammation.
Pimples and blackheads occur not only as a result of hormo-
nal changes, but rather also due to other factors as well.
Things such as psychological problems, environmental influ-
ences and disturbed eating behavior can, among other fac-
tors, also be the cause of unclear and unclean skin.
An active agent treatment concept has been developed for
targeted care of the problematic occurrence which both ef-
fectively eliminates blackheads by way of its optimum com-
position and also endows the skin with a beautiful appear-
ance and healthy look.
4 S EB O C L E A R TM- D B

Oily skin

Higher than average functioning of the sebaceous glands

The sebum cutaneum is a part of the water-fat layer which
protects the skin against outside influences and uncon-
trolled water loss and resulting dehydration. Each skin forms
its own sebum cutaneum in individual and differing compo-
sitions. Besides various fatty substances and water, sebum
cutaneum also contains salts, amino acids and urea. Over-
production by this function is encouraged by hormonal
changes during puberty, though this can also occur as a re-
sult of a poor diet high in fat and protein, as well as by exces-
sive alcohol consumption.
leads to oily skin. The increasing amount of sebaceous pro-
duced results in expansion of the pores. Oily skin can ap-
pear to look either shinny or dry, all depending on whether
the flow of sebaceous in the pore possesses an oily charac-
ter, or has already dried stiff within the hair follicle.
Oily skin is most usually unclean because it forms excellent
feeding ground for bacteria.

Hair shaft

Epidermis
Dermis
Sebaceous gland
Subcutis
Hair muscle
Sweat gland

Hair root
Blood vessels

Fatty tissue

Figure 1: The active area of SEBOCLEARTM-DB is essentially found in the epidermis, which is where influence is taken
over the production of sebaceous directly at the sebaceous gland.
NORMALISES THE SKIN
The formation
of sebum
Normally the existence of a hair is a prerequisite for a seba-
ceous gland. Occasionally these hairs can hardly be recog-
nised by the naked eye. Children do not have sebaceous
glands and therefore can not have acne either as a result.
Sebaceous glands are holocrine glands which make up a
fundamental part of the hair follicles. Holocrine means that
the cell glands are continuously renewed from below. The
sebum cutaneum is emitted and emptied out onto the sur-
face of the skin by the mouth of the follicle. In this fashion it
is insured that the skin and hair stay smooth. When the se-
baceous glands do not work well enough, the skin becomes
5
dry, chapped and brittle. If the sebaceous glands get dirty,
blackheads are formed. When they become inflamed pim-
ples are formed.
The production of sebum is under the complex control of
hormones. Androgens have the most influence over seba-
ceous gland activity and production. Bodily growth and an
acceleration in the level of production are initiated with the
onset of puberty, and first start to recede again within the
course of the aging process. Estrogens have a dampening
and inhibitory effect on the sebaceous gland-stimulating
process.
6 S EB O C L E A R TM- D B

Active ingredients

The inflammation inhibitory effect of OH

Plantago lanceolata HO OH
OH
O
Plantago lanceolata, also called “Plantain“ in English medical C
CH2
OH
O
CH CH O
terminology, belongs to the family of plantaginaceous, a O
O CH2 CH2 OH

OH
family which covers approximately 260 types. The plant is CH3
O
Acteosid
found the world over and was already commonly used as a
HO OH
medicine in ancient times. Thanks to its many healing prop-
erties, Plantago lanceolata is highly praised in several old Figure 2: Watery extracts from plantago lanceolata show
books on herbs and spices. Current indications for use were definitive inflammation inhibitory properties thanks to
described by the “Kommission E“ of the German Federal De- the acteoside. They also present a good antibacterial effect
partment of Health. For the most part, the active effect of against many gram-positive strains (eg. Staphylococcus au-
Plantago lanceolata against change in the inflammation con- reus). Different active mechanisms are mobilised thanks to
dition of the skin is of foremost importance in terms of cos- the high level of acteoside in the plantago extract being
metics. Other external applications are compiled in the used.
standard drug acceptance report. However, for the most
part the effect of eye bathes for inflammation of conjunctiva
and the application for the healing of wounds and for inflam-
mations of the throat and pharynx as a gurgle treatment are
to be emphasized.

Plantago Lanceolata
The elements contained in Plantago lanceolata are virtually
predestined for a product like SEBOCLEARTM-DB, which pre-
vents unclean skin in a mild manner and actively fights black- Acteoside
heads.

The main active ingredient of Plantago lanceolata is phenyle- antioxidising antibacterial

thanoid acteoside. Phenylethanoid acteoside demonstrates Inflammation inhibitor

extremely important key points in the fight against unclean
skin by the multifarious effects it possesses (see Figure 2 – 4).
Figure 3: In human peripheral polymorph-nuclear leuko-
cytes, acteoside retards the formation of 5-Hydroxy-
6.8.11.14-eicosatetraeous acid (5-HETE) and leukotriene B4
(LTB4). Both 5-HETE, as well as LTB4 are involved to a great
degree in the inflammation process of the skin. The reduc-
tion of the formation of 5-HETE and LTB4 is to be attributed
to the suppression of 5-lipoxygenase by acteoside.
NORMALISES THE SKIN 7

5-HETE LTB4

5-lipoxygenase

Acteoside
suppresses the activity
of 5-lipoxygenase and Inflammation
reduces the severity of
inflammation

Figure 4: In addition to this acteoside retards protein

kinase C, which then decreases the excretion of the inter-
cellular adhesion molecule ICAM-1 in turn.
As is the case with most phenylethanoids, acteoside also
possesses an antioxidising effect. This antioxidising property
of acteosid is especially effective for superoxide- and hy-
droxyl radicals, respectively. Free radicals play an important
role within the inflammation process.
Inhibition of arachidonic acid metabolism
using Mahonia aquifolium
The North Americas Indians have long known of the positive
effects of Mahonia aquifolium. Mahonia aquifolium belongs
to the family of berberidaceous (barberry bushes), is an ev-
ergreen bush and grows to a height of up to 1 m. The leaves
are egg-shaped and have a thorn-toothed edge.

The extract produced especially for this purpose using fresh Mahonia aquifolium is applied in classical homeopathy as a
Plantago lanceolata is checked over on continuously in quan- treatment against local or general itchiness and for small
titative terms for a highest standard of acteoside possible. blisters and pimples.

O
Suppression of the formation
-
of 5-HETE and LTB4
N
Suppression of protein Inflammation O
Acteoside
kinase C Inhibitory Effect
O CH3
Function as a collector of
radicals

Figure 5: SEBOCLEARTM-DB has an effective and reliable in-
flammation inhibitory effect by way of the triple effective-
ness of acteoside and together with the help of the Plan-
tago lanceolata extract.
O CH3
Figure 6: The active ingredients of Mahonia aquifolium are
alkaloids. Berberines are comprehensively involved in the
process desired most of all.
8 S EB O C L E A R TM- D B
Figure 7: Blossoming Mahonia aquifolium (Pursh) Nutt.
Figure 8: Fruits of the Mahonia aquifolium (Pursh) Nutt.
A main operation in the inflammation process is the arachi-
donic acid metabolism. Well-known authors also took up the
task of looking at the effects of alkaloids on this process.
In-vivo, the addition of berberine enacts a lowering of the
prostacykline count, which points to a reduced release of
arachidonic acid.
The arachidonic acid plays a key role in inflammations. As
the 5-lipoxygenase takes effect, the arachidonic acid reacts
to 5-HPETE and finally to LTA4. The LTA4 is converted by en-
zymatic mechanisms into 5,12-DiHETE. This enacts the ag-
gregation of leukocytes, the release of oxidising enzymes
and the creation of superoxide radicals, which have the ef-
fects of stimulating an inflammation and destroying tissue.
An excerpt from the doctoral dissertation of Dr. M. L.
Lampert of the University of Basel provides sufficient data
on the effectiveness of Mahonia aquifolium. “A growth-stim-
ulating effect of mahonia elementary tincture, a germ asso-
ciated to acne called Propionibacterium acnes was able to be
determined in-vivo. These tendencies showed themselves to
work in the direction of an antiphlogistic and antiseborrhoic
effect for the application over a period of at least 6 weeks in
two clinical studies, namely in one prospective application
observation (n = 25) and in one placebo controlled, double-
blind pilot study (n = 9). The number of inflammable acne
lesions and the oiliness of the skin seem to have been re-
duced.“
NORMALISES THE SKIN 9

COOH
Arachidonic acid
Berberine reduces the growth CH3

of arachidonic acid Activity of

the dioxygenase
OH OOH
COOH peroxidase COOH
5-lipoxygenase
CH3 CH3

5-HETE Activity of
5-HPETE
the dehydratase

O Acteoside and berberine inhibit

Non-enzymatic COOH 5-lipoxygenase and thus have
5, 12-DiHETE
5,6-DiHETE synergistic preventative effects
C5H11 Lenkotriene A4 (LTA4) against inflammation

The substances 5-HETE, 5-12-DiHETE and 5,6-DiHETE Reaction mechanism is

strengthening inflammation are efficiently retarded during formation inhibited or minimised

Active effective properties of Mahonia aquifolium
• Inhibition of the key substance, arachidonic acid, thus the
problem is pulled out by its roots.
• 5-lipoxygenase inhibitors and therefore successive reac-
tions are prevented from the beginning or kept at a mini-
mum.
On account of this Mahonia aquifolium shows a supplemen-
tary mechanism with Plantago lanceolata extract in order to
lower the substances causing inflammations to a minimum.
Keratolytic effect thanks to Salicylic Acid
Thorough cleaning of the affected areas on a daily basis is an
absolute necessity in order to achieve measurably clean
skin.
Sodium salicylate works in SEBOCLEARTM-DB as keratolytica.
Keratolytica are agents which causes the softening and des-
quamation of horn cells and thus simplify access for active
agents and treatment substances into the skin.
A decrease of the barrier function is attained by the sodium
salicylate contained in SEBOCLEARTM-DB. As a result of this
process a more even surface is also created which makes
the skin look fresher and smoother. Due to the small amount
of sodium salicylate, SEBOCLEARTM-DB is especially soft and
mild to the skin.
NORMALISES THE SKIN 11

Treatment concept
and efficacy studies

Concept Mode of action

SEBOCLEARTM-DB is an optimum self-reinforcing system for
physical and biochemical support of the skin.
All ingredient materials are natural or synthetic products
and have been scientifically tested in terms of both their
­effectiveness as well as regarding their safety.
The excellent effectiveness of SEBOCLEAR -DB for the
TM
SEBOCLEARTM-DB functions as the unique cosmetic active
principle on 3 levels:
• Plantago lanceolata and Mahonia prevent against subse-
quent inflammation occurrences of the skin
• Acteoside and berberine have an antibacterial effect
• Salicylic acid has a keratolytic effect and prevents against
blockages of the sebaceous gland

­improvement of unclean skin was proven by in-vivo meas-

urements in 20 test persons.

Scientifically confirmed effects:

• 
Effectively reduces existent skin impurities and
optimises the skin appearance (in-vivo study)
12 S EB O C L E A R TM- D B

Comedolytical effect
Reduction in %
0%

-5 %

-10 %

-15 %
-11 %
-20 %
THE REDUCTION OF PUSTULES
-30 %
AND COMEDOS (in-vivo study)
-32 %
-35 %
28 Days 56 Days
Method and implementation
The comedolytical properties of SEBOCLEARTM-DB were car- Figure 9: Comedolytical effect of an emulsion with 5 %
ried out on 20 probationers in an independent testing insti- SEBOCLEARTM-DB.
tute. The test emulsion with 5 % SEBOCLEARTM-DB (Formula-
tion A) was applied twice daily and the reduction in the
amount of comedos (a.k.a.: blackheads) and pustules (a.k.a.: Video microscopic recording
pimples) was measured after periods of 28 and 56 days, re- At the same time as counting of the comedos was taking
spectively. place, pictures of the skin were recorded after 0, 28 and 56
days using the video microscope.
The measure was taken by a dermatologist who counted
comedos forming on the forehead before and following
Volunteer Day 0
treatment. No 10

At the same time a visual judgement possibility was created

with the help of a video microscope running under
SpotLight®Software.
Day 28 Day 56
Result
The count of comedos after 28 days showed an 11 % im-
provement in the number of comedos. After 56 days, the
number of comedos had already been reduced by 32 %.

SEBOCLEARTM-DB is allowed to be characterised and re- Figure 10: Visible reduction of comedos after application
ferred to as an effective comedolytical product. of 5 % SEBOCLEARTM-DB in an emulsion.
NORMALISES THE SKIN 13

Test formulations
for the efficacy studies

Formulation A

Phase Raw material INCI name EU % [w/w]

A Water demin. Aqua Ad 100
Glycerin Glycerin 3.00
Carbopol ETD 2020 Acrylates/ C10-30 Alkyl Acrylate Crosspolymer 0.50
C NaOH solution 10 % Sodium Hydroxide, Aqua 1.75
B Belsil DM 1 Plus Dimethicone 4.00
C Keltrol F Xanthan Gum 0.20
Aqua, Alcohol denat., Sodium Salicylate, Plantago Lanceolata Leaf
D SEBOCLEARTM-DB 5.00
Extract, Berberis Aquifolium Extract
Ethanol 96 % Alcohol 5.00
Sensiva SC 50 Ethylhexylglycerin 0.50

Production
The production is carried out in a cold state / Water and glycerin mix. Carbopol is sprinkled on the surface and is allowed to
become completely wettened (15 min.). The water phase is now mixed / Neutralise with NaOH solution while stirring inten-
sively until a gel forms / Mix phase B and disperse shortly before the addition to the phase C approach in phase B / Add
phase B/C to phase A and homogenise / Add phase D and homogenise until homogenous.
14 S EB O C L E A R TM- D B

Bibliography
01 Hagers Handbuch der Drogen und Arzneistoffe; 1.Auflage CD-Rom Version, 2000; Springer Verlag, Berlin
02 Mahonia aquifolium (Purs) Nutt, M.L. Lampert, C.Andenmatten und W. Schaffner, Zeitschrift der Phytotherapie
1998; 19, Hyppokrates Verlag GmbH, Stuttgart
03 Lexikon der Biochemie und Molekularbiologie, Herder Verlag, 1991
04 Der Haut-Ratgeber, Dr.med. R.K. Acherbach, 3. Auflage; Thieme Verlag 1997; Stuttgart
05 Benninghoff Anatomie, Makroskopische Anatomie, Band 2, 15. Auflage 1994, Urban und Schwarzenberg Verlag
06 Biochemie, D. Voet and J.G. Voet, Deutsche Übersetzung 1994, VCH Verlagsgesellschaft
07 Cytologie, Histologie und mikr. Anatomie..., Otto Bucher und Hubert Wartenberg, 12. Auflage, 1997, Verlag Hans
Huber
08 Phytotherapie in der Dermatologie; M.Mennet-von Eiff und B. Meier; Zeitschrift der Phytotherapie 1995; 17;
Hyppokrates Verlag GmbH, Stuttgart
NORMALISES THE SKIN 15

09 Spitzwegerich (Pantago lanceolata L.), D.H. Paper, M. Marchesan; Zeitschrift der Phytotherapie 1999; 20,
Hyppokrates Verlag GmbH
10 Heilpflanzen 1999 CD;Thomas Brendel; Institut für Phytopharmaka; Berlin 1999
11 Römpp Chemie Lexikon, 9. Auflage, Thieme Verlag 1989
12 Spitzwegerich- Neue Untersuchungen zur antiinflammatorischen Wirkung; Marco Marchesan, Deutsche Apotheker
Zeitung 1998; Nr.32;
13 Mahonia Aquifolium (Pursh) als Dermatikum-Pharmakologische und klinischpharmakologische Untersuchungen;
Markus L. Lampert; Basel 1997
14 Enzyclopedia of common natural ingredients, second edition, Leung and Foster, John Wiley & Sons, Inc. 1996

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Version: 11/2015