SEPICALM S Sodium-PCA

					           SEPICALM S                 ™




A SOOTHING ACTIVE INGREDIENT SPECIALLY
   ADAPTED TO THE REQUIREMENTS OF
           SENSITIVE SKINS




     • Vectorised oat aminoacids enriched with minerals

     • Anti-stress

       -   Decrease erythema following         a       UV   or   a
           mechanical aggression
       -   Decrease stingings      following       a    chemical
           aggression
     • Improves cutaneous moisturization

     • Inflammation modulator

     • Ideal for sensitive skins




                          1
                           CONTENTS

1 - ATTACKS ON THE SKIN : A COMMON PROBLEM
2 - SEPICALM S : AN ORIGINAL CONCEPT
3 - SEPICALM S’s SOOTHING EFFECTIVENESS IN VIVO
3.1 – SEPICALM S’s anti-stress activity against solar irritation

3.2 – SEPICALM S’s anti-stress activity against mechanical irritation

3.3 - SEPICALM S’s anti-stress activity against chemical irritation

3.4 - SEPICALM S’s moisturizing effectiveness with emulsifier.

4 - HOW SEPICALM S ACTS
4.1 - SEPICALM S’s radical scavenger activity

4.2 - SEPICALM S’s anti-elastase activity

4.3 - SEPICALM S’s anti-hyaluronidase activity

4.4 - SEPICALM S’s anti-lipoxygenase activity

5 - Skin tolerance:
5.1 - patch test on volunteers

5.2 - HET CAM

5.3 - Sensitization

5.4 – Use test

6 - ANALYTICAL DATA
7 - REGULATORY DATA
8 - USE OF SEPICALM S IN COSMETIC PRODUCTS
CONCLUSION




                                    2
1 - ATTACKS ON THE SKIN : A COMMON PROBLEM

According to recent surveys, 70% of women aged between 18 and 65 claim to have
sensitive skin. This sensitivity manifests itself by sensations of stinging and skin
redness.

Skin sensitivity and reactivity is due to hereditary factors and can be aggravated by
our daily environment (pollution, wind, cold or heat, repeated exposure to the sun
... ) or by the increasingly frequent use of various cosmetic products (creams
containing AHAs, depilatory creams, surfactants ... ) which can in some cases
provoke unpleasant skin reactions (stinging, redness, ... ). Besides climatic and
chemical skin aggressions mechanical aggressions such as shaving an depilation
must be taken into consideration.

These aggressions damage and weaken the skin which then becomes increasingly
sensitive and less and less tolerant of external sources of stress.

• In the short term, sensations of cutaneous discomfort occur with increasing
frequency.

• In the long term, the damaged skin loses its vitality, glow, firmness and
suppleness and has the appearance of prematurely aged skin (appearance of
wrinkles and fine lines, dry and dull skin, ... ).

It is therefore clear that there is a need to incorporate into cosmetic formulations
active ingredients which counteract the effects of stress, in order to combat long
and short term damage caused by these aggressions.


HOW TO COMBAT THESE ATTACKS ?


• Because of its soothing properties a new active cosmetic ingredient SEPICALM S,
has been specifically developed by SEPPIC’s laboratories to actively help sensitive
skin to combat effectively various forms of external aggression be they chemical,
solar or mechanical.

In the short term, SEPICALM S acts specifically by fighting                    skin
inflammation caused by an attack.




                                          3
• It can therefore reduce sensations of discomfort immediately.


In the long term, SEPICALM S synergises and potentialises the skin’s
natural defence processes, by providing essential nutrients to skin cells
(lipids, aminoacids and minerals).

• It therefore helps the skin to fight more effectively against the phenomenon of
accelerated ageing.



Because of its specific properties, SEPICALM S moisturises
and soothes delicate and intolerant skin by ensuring its
comfort and protection.




2 - SEPICALM S : AN ORIGINAL CONCEPT

SEPICALM S is a new, soothing active ingredient which is specially adapted to
the needs of sensitive skin (registered patent).

Its originality resides in three key elements :

1) The selection of essential oat amino acids, a protein recognised for its
soothing properties. This complex is based on glycine, the main element of dermal
structure proteins (collagen, elastin, .... ) glutamic acid, aspartic acid and
alanine, which are generators of energy for the body.

2) The biotransformation of aminoacids into lipoaminoacids (grafting of
aminoacids onto a cocoyl chain). Because they are naturally present in the body (i.e.
lipoproteins contained in the cell membranes), lipoaminoacid structures are very
well tolerated by the skin. Their amphiphilic structure increases their bioaffinity in
the skin and allows them to vectorise aminoacids, essential cell nutriments, within
the different layers of the epidermis.




                                            4
3) Increased magnesium and potassium, minerals which are indispensable to
the metabolism of skin cells and to the needs of fragile skins.

* Potassium, an intracellular ion, is indispensable to the normal running of cells. It
is involved mainly in the use of ATP which generates energy for cells (1).

The use of potassium is recommended for its « anti-stress » property, , not just for
its contribution to the metabolism of cells, but also because it avoids the sensations
of discomfort felt when the skin is attacked. In fact, cells lacking in potassium ions
can take in large quantities of water and sodium thus causing oedema.

A potassium supplement can decrease this irritation.

* Magnesium, the second intracellular ion, is an important activator of many
enzyme systems and is recognised as an essential mineral for the maintenance of
the body’s health. In particular, it plays an important role in the metabolism of
nutrients which are indispensable to the life of a cell, such as carbohydrates, lipids
and proteins.

When the skin is attacked, the use of magnesium is highly recommended. In fact,
besides its role in the main metabolic reactions of skin cells, magnesium is an ion
integrated into the defence process. It is recognised as having « anti-stress »
properties because of its anti-inflammatory and anti-allergy activities. In the case of
an attack, it helps the body defend itself because it acts as an immunity stimulator
(2).

Moreover, a lack of magnesium in the skin appears with age (3).         A magnesium
supplement therefore helps the skin to combat the effects of stress.

SEPICALM AS A COSMETIC ACTIVE INGREDIENT:

SEPICALM S is a first choice cosmetic active ingredient because it possesses, besides
its effectiveness, an excellent cutaneous bioaffinity. Because of its amphiphilic
lipoaminoacid structure, which is naturally present in the skin (grafting of an
aminoacid onto a lipid), SEPICALM S is not only very well tolerated by the skin but is
also capable of infiltrating the different layers of the epidermis with ease so as to
participate in the protection of the skin when it is attacked.

The effectiveness of SEPICALM S against different forms of solar, chemical or
mechanical aggression has been verified in vivo on humans.

SEPICALM S’s specific action has been demonstrated in vitro.




                                           5
3 - SEPICALM S’S SOOTHING EFFECTIVENESS IN VIVO.

SEPICALM S’s effectiveness has been demonstrated on humans, by inducing
standardized cutaneous irritation.

Its effectiveness against the effects of UV radiation (solar), mechanical abrasion
(shaving and depilation) or chemical irritation (surfactants and various products)
has been assessed.

3.1 - SEPICALM S’s anti-stress activity against solar irritation


Although the sun can be good for the skin in small doses (e.g. synthesis of Vitamin
D), repeated exposure, at doses of varying intensity, can cause an erythema which is
often painful (redness, sensation of heat, tightening of the skin). Through time,
skin which is exposed to this stress is damaged, and becomes even more sensitive
to different forms of external aggression.

The effectiveness of SEPICALM S’s anti-stress activity against solar radiation was
therefore studied on humans (4).

3.1.1 - Study Principle :

The aim of this study was to assess the curative anti-stress effect of SEPICALM S in
comparison to that of glycyrrhetinic acid, an active ingredient used as a « soothing
agent » in the cosmetic industry.

The anti-stress effect was assessed on human adult volunteer after repeated
applications, under normal conditions of use, on a skin which had been previously
exposed to UV rays.

The soothing activity of the product was monitored by measuring the intensity of
the erythema colour using a colorimeter.




                                         6
3.1.2 - Formulae Studied

The anti-stress activity of SEPICALM S against UV rays was compared to that of a
placebo and that of glycyrrhetinic acid used for its soothing properties. The two
active ingredients were formulated on the same formulation base (a cream gel
containing a neutral excipient, SEPIGEL 305).

SEPICALM S’s activity was tested at a quantity of 1% active matter (that is 3% of the
product as sold) and the activity of the glycyrrhetinic acid was tested at a quantity of
1% active matter (that is 1% of the product as sold).

                        3% SEPICALM S          1% Glycyrrhetinic        PLACEBO
                                                     Acid
   SEPICALM S               1% (am)                    -                     -
   Glycyrrhetinic              -                   1% (am)                   -
         Acid
    SEPIGEL 305                2%                     2%                    2%
(polyacrylamide/C1
3-C14 isoparaffin /
 Laureth 7 -SEPPIC)
     LANOL 99                  5%                     5%                    5%
      (isononyl
  isononanoate -
       SEPPIC)
        water               qs 100%                qs 100%               qs 100%
    SEPICIDE HB                1%                     1%                    1%
     lactic acid            qs pH 5                qs pH 5               qs pH 5
   or neutrol TE

3.1.3 - Study Protocol :

This study was carried out by monitoring 5 volunteers.

At T0 :4 skin areas were selected on the back of the subject. 3 areas were treated
by the products to be studied and 1 area was exposed to UV rays and left untreated
(exposed control).
The 4 skin areas of each volunteer were exposed to the sun (UVA and UVB rays) at a
rate corresponding to a Minium Erythematous Dose (M.E.D.) using a sun simulator
whose light source is a 1000 W xenon arc lamp (a sun simulator Idem 3000 model
by ARQUANTIEL).

Just after the irradiation, the products were applied, under normal conditions, at a
quantity of 2µl/cm , over a surface of 15 cm .
                   2                           2




                                           7
At T24 : the intensity of the erythematous reactions was determined on each of the
skin areas using colorimetric measurements carried out using a CR 300
Chromometer.

This equipment assesses the skin’s color using three parameters.

« L » : Lightness measurement, a spectrum going from black to white.
« a » : Spectrum going from green to red.
« b » : Spectrum going from blue to yellow.

The development through time of the intensity of the color of the erythemae
induced will be determined by monitoring the parameter « ∆E ».               Statistical
comparisons were carried out on this parameter calculated for each of the areas
treated in relation to the control area, according to the following formula.

                                                       ∆E = [(∆a*) + (∆b*) + (∆L*) ]
                                                                   2          2            2




For the analysis and the interpretation of results, the average values of the
parameters measured on each of the treated and control areas were determined by
calculating the arithmetical average and the deviation obtained in relation to the
average (S.E.M.) of the individual measurements carried out on all the volunteers.

The values calculated on the treated areas were compared with those measured on
the control area using a variance analysis (ANOVA, significance : p < 0.05) and by
the Least Significant Difference test for multiple comparisons between the different
formulae used.

3.1.4 - Results Obtained :




                       30
                                           25%     *
                       25
 % Erythema /control




                       20                                                   16%                           16%
      reduction




                       15

                       10

                        5

                        0
                            SEPICALM S 1% (a.m.)           Glycyrrhetinic acid 1% (a.m.)        Placebo




                                                   * : significant in relation to the control




                                                                       8
SEPICALM S at a quantity of 1% a.m. significantly reduces erythema intensity by 25%
in comparison to the control.

The decrease in erythema intensity obtained with glycyrrhetinic acid and with a
placebo is 16% and is not significant in comparison to the control.

SEPICALM S therefore helps to combat external UV type
attacks effectively. Its activity is more effective than that
of glycyrrhetinic acid, whose renown soothing qualities
have been tested and which is commonly used for its anti
erythema properties.

3.2 - SEPICALM S’s anti-stress activity against mechanical irritation


The skin can be subjected to mechanical aggressions on a daily basis.

Mechanical abrasion occurs during shaving or epilation. This repeated « scratching»
of the skin gradually removes a part of the corneocyte layer which forms the upper
part of the epidermis whose essential role is to protect the skin against external
aggressions. When altered the stratum corneum becomes a less effective barrier
making the skin even more sensitive.

The anti-stress activity of SEPICALM S against mechanical abrasion was therefore
studied on humans and compared with a placebo formula (5).

3.2.1 - Study Principle :

The aim of this study is to assess the curative anti-stress effect of SEPICALM S in
comparison to the placebo formula. This effect was assessed under normal
conditions of use on a skin which was already irritated in a standard manner by
mechanical abrasion on the Human adult volunteer.

The soothing activity of a given product was monitored by measuring the intensity
of the erythema colour (parameter « a »), using a colorimeter.




                                         9
3.2.2 - Formulae studied

The activity of SEPICALM S was tested at a quantity of 3% of the product as sold, in
comparison to a placebo formula (without active ingredient).

                                    SEPICALM S 3%                PLACEBO
        SEPICALM S                     3% (a.s.)                     -
        SEPIGEL 305                      2%                         2%
 (polyacrylamide/C13-C14
  isoparaffin / Laureth 7 -
           SEPPIC)
         LANOL 99                           5%                       5%
  (isononyl isononanoate -
           SEPPIC)
            water                         qsp 100%               qsp 100%
        SEPICIDE HB                          1%                     1%
         lactic acid                      qsp pH=5               qsp pH=5
        or neutrol TE
              pH                            5.07                    5.15

3.2.3 - Study Protocol

This study was carried out by screening 5 volunteers.

An erythema was provoked in a standardised manner using mechanical abrasion on
two symmetrical areas of the forearms. The soothing effect of the formula
containing SEPICALM S was determined by the decrease in skin redness 30 minutes
after application of the product. This value was compared with that obtained with
the placebo formula.

The development through time of the intensity of the color of the erythema induced
shall be determined by monitoring parameter « a ».

The protocol outline is the following :

1. Induction of an erythema on two symmetrical areas situated on the
   forearms by standardized mechanical abrasion :
2. T=0, assessment of the colour of the erythema induced on the two symmetrical
areas (measurement of parameter « a » using the comparator).
3. Just after inducing the erythema, a product was applied with or without active
ingredient on the respective area (8 mg/cm ). One area is treated with the active
                                                   2



ingredient the other with a placebo.
4. T=30 min. Measurement of the intensity of the erythema on the two areas 30
minutes after application of the product (measurement of parameter « a » using the
comparator).



                                             10
3.2.4 - Results Obtained

In order to compare the development of the erythema’s colour on the areas treated (with or
without active ingredient), the percentage variation of the skin colour (∆) obtained through
time between the two areas was calculated for every volunteer. The mathematical formula
used was the following :
                                       (A30- A0) - (P0-P30)
                                 ∆ % = ------------------------------ X 100
                                           (P30- P0) + A0
P0              : value of parameter « a » on the placebo area, just after inducing the erythema
                (before applying the product).
P30             : value of parameter « a » on the placebo area, after inducing the erythema and 30
                minutes after applying the product.
A0              : Value of parameter « a » on the area to be treated with the active ingredient, just
                after inducing the erythema (before applying the product);
A30             : value of parameter « a » on the area treated with the active ingredient, after
                inducing erythema and 30 minutes after applying the product.
* This formula takes into account the possible variations in colour which may exist between the two
symmetrical areas before application of the products, as well as their possible development through
time and independently of the treatment used.


According to this calculation, the percentage variation of the erythema colour on the
arm treated with SEPICALM  S is determined, in comparison to the arm treated with
the placebo formula, 30 minutes after applying the product, as being -7.4%.

       Mechanical abrasion : SEPICALM S’s soothing effect compared with a
                                 placebo in vivo

                           10            7,4%
                            9
      % Erythema/placebo




                            8
                            7
           reduction




                            6
                            5
                            4
                            3
                            2                                                  0%
                            1
                            0
                                SEPICALM S                              Placebo
                                  3%(as)
SEPICALM S in a quantity of 3% reduces erythema intensity in comparison to the
placebo formula.

SEPICALM is therefore used to combat external aggressions
of a mechanical type (shaving or depilation) effectively.




                                                     11
3.3 - SEPICALM S’s anti-stress activity against chemical irritation

• STINGING TEST

The skin is subjected to attacks from different products on a daily basis.

For example, the daily use of specific products such as surfactants (shower gels,
soaps, ... ) has a defattening effect on the stratum corneum and causes, in the
long term, damage to the skin barrier as well as skin dryness. Depilatory creams or
creams containing alphahydroxyacids (AHAs) can also provoke, in some cases,
localised reactions of discomfort (stinging, tight skin and redness ... ).

The anti-stinging effectiveness of SEPICALM S against these chemical irritations was
therefore studied on humans (6).

3.3.1 - Study Principle :

The aim of this study is to assess the soothing and anti-stinging effect of
SEPICALM S after a single application under normal conditions of use on a Human
adult volunteer with « sensitive and reactive » skin selected using the « Stinging
Test » method (« Positive stingers »).

The soothing activity of SEPICALM S was determined by measuring the decrease in
the intensity of the stinging induced by application of a lactic acid solution to the
nasolabial folds (a very sensitive area).

3.3.2 - Formula Studied :

SEPICALM S’s activity was tested at a quantity of 3% of product as sold (that is 1%
active matter).
                                                      SEPICALM S 3%
                SEPICALM S                                3% (a.s.)
              MONTANOV 68                                    7%
        (Cetearyl glucoside -SEPPIC)
            SCHERCEMOL 1818                                 15%
          (isostéaryl isostéarate)
                    Water                                  75.5%
  SEPIGEL 305 (polyacrylamide/C13-C14                        2%
      isoparaffin / Laureth 7 -SEPPIC)
                Preservatives                               0.5%
              Lactic acid 50%                            qsp pH=5
                     pH                                     5.15




                                          12
3.3.3 - Study Protocol

This test was carried out on 10 volunteers with very sensitive skin.

* Before starting the test, volunteers with « hypersensitive » skin were selected. This
selection was carried out using the Stinging Test:

. a 10% solution of lactic acid in isotonic solution was applied to the nasolabial folds.
. stinging sensations were then assessed immediately after applying the product to
the two folds on the basis of a visual scale of 6 points.

* Once the « positive stingers » had been selected, the test could be undertaken :

. A 10% lactic acid solution was applied to the two nasolabial folds (right and left
side) of each volunteer.

. The product containing 3% SEPICALM S as sold was applied once, under normal
conditions of use, as soon as the stinging induced by the lactic acid occurs.

. The intensity of the stinging was assessed over 5 minutes following application, on
the area where the lactic acid (control) was applied and on the area treated with the
product to be studied.


3.3.4 - Results Obtained:

The average intensity of the stinging was determined for each point in time of the
test by calculating the average (S EM) of the individual data obtained from all the
volunteers.

A statistical analysis was carried out, firstly, on values obtained on the area treated
with the product studied in comparison to the values obtained on the control area
and, secondly, on the differences calculated between the values obtained at a given
time and those determined after applying lactic acid (that is, before applying the
product studied : time « 0 ») for each of the treated and control areas.




                                           13
                                                               Stinging Intensity

                                                                  OBSERVATION TIME
                                                                    (after application)
PRODUCTS                             T0 (before    immédiatel 10 sec 30 sec     1 min                 2.5        5 min
                                    application)     y after                                          min
                                                   application
   Lactic
    acid                             3.0 ± 0.4     2.6 ± 0.3        2.5 ±            2.1 ±    2.1 ±   1.6 ±       0.6 ±
  control
                                                                     0.3              0.3      0.2     0.3         0.2

  0.75%                              2.8 ± 0.4     1.4 ± 0.5        1.0 ±            0.6 ±    0.2 ±   0.2 ±       0.1 ±
 soothing
                                                      *              0.4              0.3      0.1     0.1         0.1
 complex
                                                                    * •              *   •    * •     *   •       *   •


* : a statistically significant value in relation to the value of the control area (lactic
acid alone) (ANOVA, significance : p<0.05)

   : a statistically significant value in relation to the value determined before
applying the product studied, at time « 0 » for the same area (Wilcoxon’s non
parametrical Test in matched series, significance p<0.05).

• : a statistically significant value in relation to the value obtained from the control
area by comparing the differences calculated between the value determined at a
given time and the initial value obtained at time « 0 » (Wilcoxon’s non parametrical
test in matched series, significance p<0.05).

                                             SEPICALM S’s anti-stinging effect in vivo


                          3,5

                           3
     Stinging Intensity




                          2,5

                           2
                                       - 46%                                                          Lactic acid control
                          1,5

                           1                                                                          3% SEPICALM S
                                                                                                      as + lactic acid
                                                       - 90%
                          0,5

                           0
                                0       50       100       150      200        250      300    350
                                                           time (seconds)




                                                                          14
Application of lactic acid to the control area causes a persistent stinging sensation
for up to 5 minutes.

• The use of SEPICALM S at a quantity of 3% leads to a statistically significant
decrease in stinging intensity when compared to the control area, immediately after
application and throughout the following 5 minutes.

• The intensity of the stinging decreased, when compared to the control area, by
approximately 46% immediately after application of SEPICALM S and by
approximately 90% one minute after application.

Nota : The intensity of the stinging felt in the area treated with lactic acid decreases
through time but always remains greater than the side treated with the soothing
complex.


• SEPICALM S, after a single application to the skin, has a marked, soothing
and anti-stinging effect, which is immediate and persistent, on the sensations
induced on the nasolabial folds with a 10% lactic acid solution, on people with
« hypersensitive » skin.

The use of SEPICALM S at a quantity of 3% is recommended
for the treatment of sensitive skins.

3.4 - SEPICALM S’s moisturising effectiveness : a moisturising
synergy with an emulsifier of vegetable origin MONTANOV 68
(glucolipid - SEPPIC) (7)

Attacks to the skin, especially of a chemical nature, cause a disturbance of the
hydrolipid film, which can no longer fulfil its skin moisturising functions.
This dryness, felt systematically by almost everyone who has delicate and sensitive
skin, aggravates sensations of intolerance caused by these aggressions (tight skin,
stinging ... )

The hydrolipid film which is composed essentially of aminoacids, minerals and lipids
can be partly reconstituted thanks to SEPICALM S.

We therefore verified the moisturising effectiveness of SEPICALM S on the Human.




                                           15
3.4.1 - Study Principle :

The aim of the study was to assess the moisturising power of SEPICALM S at a
quantity of 3% (as sold) by screening 10 volunteers for a period of 5 hours
(assessment at T0, T1H30 and T 3H).

In order to be able to propose a formula which was effective in not only
« soothing » but also « moisturising », we demonstrated a synergy of action between
SEPICALM S and an emulsifier of vegetable origin, recognised as having immediate
moisturising properties, but not long term ones.

The formulation base alone and the formula with the active ingredient were tested.

3.4.2 - Formula Tested :

SEPICALM S was formulated at a quantity of 3% (a.s.) in an emulsion containing a
glucolipid of vegetable origin, MONTANOV 68 (Cetearyl glucoside - SEPPIC). Besides
its excellent emulsifying properties, this excipient also possesses interesting and
immediate moisturising properties.


This type of formulation was therefore chosen so as to demonstrate a
potentialisation of the moisturising efficiency of the formula due to the use of
SEPICALM S.


                                 3% SEPICALM S          Formula without active
                                    Formula                  ingredient

        SEPICALM S                      3%                           -
    SCHERCEMOL 1818                    15 %                        15 %
  (isostearyl isostearate-
           SEPPIC)
            water                     73.5 %                     80.25 %
       MONTANOV 68                     7%                          7%
    (cetearyl glucoside -
           SEPPIC)
           SEPIGEL                     1%                          1%
(polyacrylamide/C13-C14
 isoparaffin / Laureth 7 -
            SEPPIC
        Preservatives                 0.5%                        0.5%
         Lactic acid                qsp pH 5                    qsp pH 5


3.4.3 - Study Protocol :


                                         16
An in vivo study carried out by screening 10 healthy volunteers.

At T0 :

- Determination of three skin areas on each forearm. 2 areas treated by the
products to be tested, 2 symmetrical areas treated with placebos and 2 non treated
areas.

- Measurements of the moisturising rates using a corneometer on the 6 areas.

- Application of the 2 products and the 2 placebos on the areas concerned.

At T 1H30, T3H and T5H :

- Measurement of the moisturising rate using a corneometer on the 6 areas studied.

3.4.4 - Results Obtained :

The results were expressed as a percentage in variation (ratio between the 2 areas at
the same moment of the study and in comparison with the initial value obtained at
T0). The average between 2 different areas was calculated on 10 people.

Statistics were obtained from the results : Student’s bilateral « t » Test on matched values, at a risk α =
0.05. The H0 hypothesis is that there is no significant difference when the product is applied.
Because of the multiple comparisons (t0 compared to t 1H30, t 3H, and t 5H), the product’s effect is
considered to be significant for a probability (p) less than 0.01.


                               SEPICALM S’s moisturising effect in vivo



                       25
                            +24%*
    % moisturisation
    increase/control




                       20                         +18%*                                  SEPICALM S 3%
                                                                                         (as)
                                                                           +15%*
                       15            +13                                                 SEPICALM free
                                                                                         formula
                       10                                 +8%                            untreated area
                                                                                   +5%
                        5

                        0
                            1 h 30               3h                   5h




                                 * : significant in comparison to the non-treated area
An immediate and long term moisturising effect was observed with the
formula containing 3% SEPICALM S (significant increase in moisturisation, in


                                                          17
comparison to the non-treated control area, 1 H 30, 3H and 5H after applying the
product).

On the other hand, as expected, the formula which did not contain SEPICALM S had
only a short term moisturising effect (significant increase only 1 H 30 after applying
the product).

⇒The use of SEPICALM S in a quantity of 3% can potentialise the
moisturising effectiveness of the formula through time.

Besides its soothing properties, SEPICALM S also plays an
active role in moisturising the skin.

SEPICALM S thus diminishes the feeling of tightness or
stinging experienced when the skin has been attacked.




4 - HOW SEPICALM S ACTS


SEPICALM S is a very interesting cosmetic active ingredient because of its various
anti-stress properties demonstrated on humans.

For scientific reasons, we wanted to understand why it is effective by determining its
mode of action.

SEPICALM S acts as an « anti-stress » agent on the skin because of its two fold
protective action :

1) Non specific protective action : Thanks to its composition, which is rich in
essential nutrients, SEPICALM S restores the damaged hydrolipid film and acts in
synergy with the natural metabolism of the skin cells, thus reinforcing the skin’s
defences against attack.

* Restoration of the hydrolipid film :

Attacks of a chemical nature very often cause delipidation of the stratum
corneum. This phenomenon leads to an imbalance in the skin’s hydrolipid film
which no longer fulfils its protective role (decrease in the cohesion of the corneocyte
layer, increase in cutaneous evaporation leading to dry skin ... ).




                                          18
• To combat the damage caused by chemical attacks, the skin needs an active
ingredient able to restore the hydrolipid film which is essentially composed of a
lipophilic part (lipids) and a hydrophilic part (aminoacids, minerals).

SEPICALM S helps restore the skin’s hydrolipid film by
reconstituting it using aminoacids such as glycine, aspartic
acid, glutamic acid and alanine, lipids and mineral salts such as
potassium and magnesium.

* Potentialisation of the natural metabolism of skin cells.

- Mechanical aggression such as shaving and depilation, reduces the thickness of
the corneocyte layer through abrasion. When it is damaged, the stratum corneum
fulfils its barrier function less effectively against external aggression .

Moreover, skin cells, when subjected to stress on a daily basis, become fragile and
their defence decreases with each aggression.

• To combat this damage, the skin requires topical applications of an active
ingredient capable of potentialising the skin cell metabolism. In this way the
stratum corneum is rapidly restructured and skin cells are « reinforced » against
further attacks.

Because of its amphiphilic structure, SEPICALM S provides cells with
elements indispensable to their metabolism such as aminoacids (glycine,
aspartic acid, glutamic acid and alanine) as well as potassium and
magnesium.

The cells are stronger and can defend themselves more effectively against
external aggressions and can restructure the skin more rapidly (e.g.
collagen synthesis, ..)

2. Specific protective action : Because of its composition, SEPICALM S, inhibits
mediators produced during inflammation.

During external attacks on the skin, erythema is often the indication of an
inflammation of greater or lesser intensity. Erythema is sometimes slight in the case
of a chemical or mechanical aggression. However it is often a great deal more
intense after exposure to UV radiation.

Diagramatically, what happens when the skin is irritated?

As soon as the skin is stressed, the cells of the epidermis are stimulated and, to
alleviate imminent damage to the cutaneous barrier, they produce cell mediators
known as cytokines.         Keratinocytes, by producing these cytokines, activate
fibroblasts, through intercellular communication, which increase collagen synthesis.




                                         19
Langerhans’ cells, which are immunocompetent cells of the epidermis recognising
« themselves » and « not themselves », can start an inflammatory reaction by
producing cytokines, namely the production of free radicals and the stimulation of
pro-inflammatory enzymes          such   as    elastase, hyaluronidase and
lipoxygenase.

The free radicals produced contribute to cell death by altering lipids and proteins.
Elastase and hyaluronidase are enzymes which deteriorate tissue matrices
(collagen, elastin).
By degrading arachidonic acid, lipoxygenase induces the synthesis of inflammation
mediators such as leukotrienes. These mediators, by propagating inflammation
symptoms, potentialise sensations of heat, pain or stinging linked to the increase of
the skin’s microcirculation.

SEPICALM S decreases irritation, by inhibiting the production of the main
inflammation mediators such as free radicals, elastase, hyaluronidase and
lipoxygenase.


4.1 - SEPICALM S’s radical scavenging activity


Free radicals are activated chemicals, produced in vivo under normal or pathological
biological conditions. However, various external sources of aggression such as
chemical, mechanical and solar aggression, stress, pollution, alcohol and tobacco
increase their formation which has very unpleasant effect on the cell (8).

Within the cell, free radicals can cause peroxydation of the polyunsaturated fatty
acids in the phospholipid membranes, the formation of cytotoxic peroxides, the
oxidation of proteins and a denaturation of DNA. All of these phenomena
contribute very frequently to cell death.

Outside the cell, free radicals break down the main constituents of connective tissue
(elastin and collagen), which contributes, in the long term, to general skin ageing.

If the chemical or enzyme detoxification systems naturally present in the body are
overwhelmed (this can vary from individual to individual), the skin defences should
be reinforced with topical applications of radical scavenging active ingredients.

Because of its radical scavenging action, SEPICALM S can protect the skin against the
harmful effects of free radicals produced by an attack.




                                         20
4.1.1 - Test Principle :

This in vitro test assessed the radical scavenging properties of SEPICAL S
against the superoxide anion (9).

The radical scavenging activity of SEPICALM S was compared to that of several
molecules widely used in cosmetics for their « soothing properties » : allantoin,
alpha bisabolol (camomile extract) and di-potassium glycyrrhizinate (liquorice
extract).

To highlight the specific effectiveness of SEPICALM S’s lipoaminoacid
structure, the radical scavenging activity of lauric acid alone, and that of a
mixture of aminoacids (aspartic acid, glutamic acid, alanine and glycine) used for
the synthesis of the complex, were tested.

Determination of the radical scavenging effect was based on the inhibition or the
decrease in the speed of reductionof cytochrome C, by adding to the reactional
medium a molecule which is studied.

The superoxide anion was generated by the action of xanthine oxydase on xanthine.
In the absence of a molecule able to capture it, it reduced the cytochrome C. The
appearance of reduced cytochrome C was monitored using a spectrophotometer at
550 nm in the presence (for the test) and the absence (for the control) of radical
scavenging molecules.


           xanthine oxydase                           Oxidised Cytochrome C
                                                          (colourless)



xanthine --------------------------> O2.- ------------------------------> Reduced
                                                                      Cytochrome C
                               (superoxide anion)                       (coloured)
                                                                   measures OD/min
                                                                      of appearance

       RADICAL SCAVENGING                                     REACTION
            MOLECULE                                          INHIBITION
                                                        (decrease in OD/min of
                                                      appearance in comparison
                                                              to control

The reaction was carried out in a spectrophotometer with a thermostat fixed at 25°C
and which was equipped with a sample passer. All the kinetics were carried out at
least three times. The average and the standard deviation were calculated for the
three values obtained.


                                                 21
A percentage of inhibition of the speed of appearance of the coloured product
(corresponding to the quantity of free superoxide anion) would therefore be
calculated for each active ingredient tested. This calculation was carried out in
relation to the speed of appearance of the coloured product in the control (without
active ingredient).

The percentage of inhibition of the appearance of the coloured product by
the active ingredient would therefore correspond to the percentage of
inhibition of the superoxide anion (= radical scavenging activity).


4.1.2 - Results Obtained :

       Radical scavenging activity of SEPICALM S lipoaminoacid form


                                                            78%
                                            90
        % r a d ic a l s c a v e n g in g




                                            80

                                            70

                                            60

                                            50

                                            40

                                            30

                                            20                                       0%                     0%
                                            10

                                             0
                                                 S E P IC A L M          L a u r ic a c id      m ix t u r e a m in o
                                                 S 0 .1 % a m              0 .1 % a m          a c id s 0 .1 % a m


                                                     * aspartic acid, glutamic acid, alanine and glycine.


SEPICALM  S has an excellent radical scavenging effectiveness.

The lauric acid and the amino acids mixture (aspartic acid, glutamic acid, alanine
and glycine) tested alone did not indicate any radical scavenging activity at the
concentrations tested.    This demonstrated the specific effectiveness of
SEPICALM S lipoaminoacid structure.




                                                                              22
    SEPICALM S radical scavenging activity compared to that of standard
                            soothing products


                                       78%
                             80
      % radical scavenging




                             70
                             60
             activity




                             50
                             40
                             30
                                                     10%                 10%
                             20
                                                                                       0%
                             10
                              0
                                  SEPICALM      Allantoin             DiK+
                                                                                   α Bisabolol
                                  S 0.1% a.m.   0.1% a.m.        Glycyrrhizinate
                                                                                   0.1% a.m.
                                                                   0.1% a.m.

Under selected test conditions, SEPICALM S has a radical
scavenging activity which is much greater than the other
molecules currently used in the cosmetics industry for
their « soothing » properties.

4.2 - SEPICALM S anti-elastase activity :


Human leukocyte elastase (HLE) is presently the subject of many studies because it
is involved in a good number of inflammation pathologies. This enzyme, produced
especially when the skin is aggressed, is able to break down many macromolecules
such as fibrous elastin, some types of collagen, proteoglycans and glycoproteins
and it is one of the links in the chain of reactions which occur during inflammation
(10) (11).

• Blocking this enzyme using an anti-elastase effect therefore involves impeding
the breakdown of all these molecules and also inhibiting the inflammation process.

The antielastase activity of SEPICALM S was compared with that of several molecules
widely used in cosmetics for their soothing properties i.e. allantoin, alpha bisabolol
(camomile extract) and di potassium glycyrrhizinate (liquorice extract).

In order to highlight the specific effectiveness of the lipoaminoacid structure of
SEPICALM S, the anti-elastase activity of lauric acid alone, and that of a mixture of
aminoacids (aspartic acid, glutamic acid, alanine and glycine) used for the
synthesis of the complex, were tested.




                                                            23
4.2.1 - Test Principle :


The anti-elastase properties of a product can be highlighted by an in vitro test
carried out using a spectrophotometer (12).

These anti-elastase properties were studied using HLE and N-methoxysuccinyl-
alanine-proline-valine-paranitroanilide (colourless product). Hydrolysis of the
substrate using HLE released a coloured product, para-nitroaniline whose
appearance kinetic was monitored using a spectrophotometer at 410 nm.


The anti-elastase effect of the product was then calculated in relation to a control
curve obtained in the absence of the product.




          N-methoxy succinyl - alanine - proline - valine - para-nitroanilide
                               (colourless substrate)


      Human leukocyte                                        ANTI ELASTASE
        elastase                                                   MOLECULE


                            Para-nitroanilide  +         P
                                (Coloured product)
                                       410 nm
                                measures OD/min


                   anti-elastase molecule
                REDUCTION IN PRODUCT APPEARANCE


The reaction was carried out in a spectrophotometer with a thermostat set to 25°C
and equipped with a sample passer. All the kinetics were carried out at least three
times. The average and the standard deviation were calculated for the three values
obtained.

The percentage of inhibition of the appearance of the coloured
product by the active ingredient corresponds therefore to the
percentage of HLE inhibition.




                                          24
4.2.2 - Results Obtained :



                                  The anti-elastase activity SEPICALM S lipoaminoacid form




                                                 80
                             90

                             80
   % a n t ie la s t a s e




                             70

                             60

                             50

                             40

                             30

                             20                                              0                        0
                             10

                              0
                                     S E P IC A L M             L a u r ic               A m in o a c id
                                       0 .0 2 %                  0 .0 2 %                     0 .0 2 % a m



                                             * aspartic acid, glutamic acid, alanine and glycine.



SEPICALM S has an excellent anti-elastase effectiveness.

The lauric acid and a mixture of amino acids (aspartic acid, glutamic acid, alanine
and glycine) tested separately did not indicate any anti-elastase activity at the
concentrations tested.   This demonstrated the specific effectiveness of
SEPICALM S lipoaminoacid structure.




                                                                     25
       SEPICALM S anti-elastase activity compared to that of standard soothing
                                      products :


                                    80%
                           80

                           70
 % antielastase activity




                           60

                           50

                           40

                           30
                                                10%                 10%
                           20
                                                                                   0%
                           10

                           0
                                                                  DiK+
                                SEPICALM   Allantoine                          α Bisabolol
                                                             Glycyrrhizinate
                                 S 0.02%   0.02% a.m.                          0.02% a.m.
                                                               0.02% a.m.


Under selected test conditions, SEPICALM S has an anti-
elastase activity which is much greater than the other
molecules currently used in the cosmetics industry for
their « soothing » properties.


4.3 - SEPICALM S anti-hyaluronidase activity


Hyaluronidase is another enzyme produced when the skin is attacked.

It is stimulated during inflammation, and is capable of breaking down hyaluronic
acid, a polysaccharide acid which forms the connective tissue of animal, and has a
role not only in the mechanical properties of the dermis but also in skin
moisturisation. This enzyme is also involved in allergic processes (liberation of
histamine).

It should be mentioned here that anti-inflammatories such as aspirin, indometacine
or mefenamic acid are known to be very good inhibitors of hyaluronidase.

This is why we tested the anti-hyaluronidase activity of SEPICALM S in relation to that
of di-potassium glycyrrhizinate, a liquorice derivative, used as a soothing agent
in the field of cosmetics and described in the relevant documentation as an inhibitor
of this enzyme.


                                                        26
4.3.1 - Test Principle :


The anti-hyaluronidase activity was assessed using a semi-quantitative biochemical
method in gelose (13).

The hyalurodinase activity was assessed on gelose containing hyaluronic acid (its
substrate). After the enzyme had been incubated in the presence or absence, of the
products to be studied, a compound, cetylpyridinium chloride, at a quantity of 10%,
reacted with the hyaluronic acid which had not been broken down, forming a white
precipitate.




                                    Test Principle


                            lysis diameter measurement




      control                                                    gelose +
      enzyme                                                  hyaluronic acid




                                                       SEPICALM     S   +   enzyme
      dipotassium glycyrrhizinate
            + enzyme




- A product’s lack of enzyme inhibition by a product was therefore indicated by a
clear area in the gelose under the deposit.

- Enzyme inhibition by the product to be studied was indicated by a white area which
appeared under the deposit.

SEPICALM S’s anti hyaluronidase activity was tested at 0.1% (active matter) and
compared to that of di-potassium glycyrrhizinate.




                                          27
4.3.2 - Results Obtained


SEPICALM S’s anti-hyaluronidase activity compared to that of di-potassium
                            glycyrrhizinate :



                                          100%
                             100
       % antihyaluronidase




                             80


                             60
                                                                50%

                             40


                             20


                              0
                                   SEPICALM S         DiK+Glycyrrhizinat
                                    0.1%(a.m.)            0.1%(am)


At 0.1% SEPICALM S inhibited hyaluronidase completely, while the dipotassium
glycyrrhizinate only inhibited at a rate of 50%.

SEPICALM S at a quantity of 0.1% has an anti-hyalurodinase
activity twice that of di potassium glycyrrhizinate.


4.4 - SEPICALM S anti-lipoxygenase activity


Lipoxygenase is an enzyme stimulated during inflammation which can be induced
by a skin irritation.

Following a stimulus, phospholipase A2 is activated, increasing the synthesis of
arachidonic acid in the skin. After several cascade type reactions, lipoxygenase, a
pro-inflammatory enzyme breaks down the arachidonic acid into leukotrienes, which
are inflammation mediators.

We therefore tested the anti-lipoxygenase activity of SEPICALM in comparison to that
of di-potassium glycyrrhizinate, a liquorice derivative, used as a soothing agent in
the cosmetic industry and described in the relevant documentation as an inhibitor of
this enzyme




                                                 28
4.4.1 - Test Principle


The lipoxygenase activity was quantified using an in vitro immunoenzyme method
(14).

• The lipoxygenase was incubated with its substrate, arachidonic acid, and the
production of leukotrienes was monitored using immunoenzymology.

The percentage of enzyme inhibition was manifested by inhibition of the quantity of
leukotriene produced in the presence of the active ingredient to be tested
(comparison with a control without active ingredient).

The reaction was validated by a specific standard inhibitor of lipoxygenase (NDGA :
nordihydroguaretic acid).

SEPICALM S was               tested   in   comparison   with   0.05%   am    di   potassium
glycyrrhizinate.


4.4.2 - Results Obtained :

 SEPICALM S anti-lipoxygenase activity compared with that of di potassium
                            glycyrrhizinate.


                                           81%
                        90
                        80
   % antilipoxygenase




                        70
                        60
         activity




                        50
                        40
                                                                       20%
                        30
                        20
                        10
                         0
                             SEPICALM S                   DiK+Glycyrrhizinate
                              0.05%(am)                       0.05%(am)
At a quantity of 0.05% am, SEPICALM S inhibited at a rate of 81%. In
comparison, at this same concentration, the di potassium glycyrrhizinate
inhibited the lipoxygenase at a rate of 20%.

SEPICALM S, in a small concentration, inhibits lipoxygenase
four times more than the standard molecule, di potassium
glycyrrhizinate.


                                                 29
              SUMMARY OF SEPICALM S EFFICACY

                               SEPICALM S EFFICACY



         IN VIVO EFFICACY                                  IN VITRO

• Decrease erythema following a                • Modulator of inflammation
UV or a mechanical stress                      process
• Decrease stingings following a               • Free radicals
chemical stress                                • Inflammatory enzymes
• Improve cutaneous                            (elastase, hyaluronidase,
moisturization                                 lipooxygenase)




          WHAT’S HAPPEN FOLLOWING A CUTANEOUS STRESS?


                                    SKIN STRESS


    Free radicals production                                 Activation of
                                                        inflammatory enzymes



     Cell death                Elastase        Hyaluronidase        Lipooxygenase




     Harmful effects                  Tissue matrix       Leucotriens (inflammation
        on skin                        degradation               mediators)


                                                                   inflammation



SEPICALM S activity being greater than that of different molecules used as
« soothing agents » in the field of cosmetics, its use is highly recommended not
only for products intended for daily care of sensitive skin but also for
products where a soothing property is sought (after sun care, after shave
balm, after depilation milk ... ).




                                          30
5- SKIN TOLERANCE

5.1 – Skin PATCH TEST


SEPICALM ™ S, tested at 10% (initial pH 5.6) using a simple patch test gives a result
of 0.1, which demonstrates the good skin tolerance of this active ingredient (15).

5.2 - HET CAM

This method is an alternative to animal experimentation for assessing the
ocular irritation potential of cosmetic products (16).
The principle is based on observation, by a trained person, of irritating effects
(hyperhemia, hemorrhage, coagulation) which can occur in the five minutes
following the deposit of a product on the chorio-allantoic membrane (CAM) of a
fertilised hen’s egg at the tenth day of incubation.
This method is can be applied to the assessment of the ocular irritation potential of
cosmetic products (SEPPIC procedure n° 57CO 009)

Product classification:

The tested product (pure or dilute) is classified according to the scale in the
following table:

              Notation (N)                              Classification
                  N< 1                              in practice non irritant
                1 < N<5                                 slightly irritant
                5 < N> 9                              moderately irritant
                  N>9                                       irritant

When tested at 0.3% (equivalent to 3% on a rabbit) SEPICALM ™ S gives a reading of
0.
SEPICALM ™ S is therefore considered as being NON IRRITANT at the recommended
concentration.




                                         31
5.3 - SENSITISATION

Tested at 5 % in water in 50 volunteers according to Marzulli Maibach protocol,
SEPICALM S is not sensitising (17).

5.4 Use test

Tested at 3% in a use test on 20 volunteers having a sensitive skin (2 applications
per day during 3 weeks), SEPICALM S have been well tolerated. (18)




6 - ANALYTICAL DATA

CHARACTERISTICS                 LIMITS                     METHODS
Appearance                      clear to slightly cloudy   GL: 24040
                                liquid
pH (on product a.s.)            5.4- 6.2                   GL:   24040
Active matter                   approximately 32%          GL:   24040
Magnesium content               approximately 350 ppm      GL:   24040
Potassium content               0.10 – 0.30 %              GL:   24040
Sarcosine content               5–7%                       GL:   24040
Free fat acids                  4–6%                       GL:   24040
Propyleneglycol content         17 – 23 %                  GL:   24040
Germs                           100 germs/g                GL:   24040

Nota The values in this table are only given as indications. The only analytical
     specifications guaranteed are those mentioned on the analysis certificate
     supplied with each delivery.

Solubility:

Soluble in water and glycols.

Quantity of SEPICALM S in finished products:

The presence of SEPICALM S in finished products, can be verified by determining the
quantity of its tracer, magnesium (by atomic absorption).




                                            32
7 - REGULATORY DATA


- INCI Name:

Sodium cocoyl aminoacids, sarcosine, potassium aspartate, magnesium aspartate.

- CAS and EINECS Numbers:

CAS:        90387-74-9/ 90170-45-9/ 90170-86-8/ 68187-32-6/ 107-97-1/
            2068-80-6/ 1115-63-5

EINECS:     2913505/ 2904789/ 2905232/ 2990872/ 2035386/ 2181916/
            2142264




8 - USE OF SEPICALM ™ S IN COSMETIC PRODUCTS

Because of its soothing properties, SEPICALM S is new active ingredient which may
be incorporated at a quantity of 3 to 4% (a.s.) in all types of formulations where
a soothing property is desired:

* care products for sensitive skin (face, contour of the eyes, baby care
products);
* after sun care products;
* after shave or after depilation care products;
* care products for irritated scalp (for example, antidandruff products.);
* specific care products (deodorants, colouring products, permanent products,
products for acne prone skins.) ;
* make-up (powder, foundation, lipstick).




                                        33
Because it is non sensitizing, SEPICALM S is very suitable for hypoallergenic
products.

As a hydrodispersible active ingredient, SEPICALM S can be incorporated into all
types of formulation without any difficulty,

* O/W and W/O emulsion:
- creams, milks, lotions, wipes, face and eye make-up removing products, makeup,
foundation.

* lotions

* foaming products:
- shampoos, antidandruff shampoos, shower gels, make-up removing gels, liquid
soaps, syndets, antibacterial soaps, intimate hygiene products.

Thanks to its soothing properties, SEPICALM S can be used in all products containing
constituents of varying irritation levels such as the aluminum salts in deodorants
and AHAs.

SEPICALM S can also be used successfully in antidandruff formulas or formulas for
acne prone skin. When combined with an antidandruff active ingredient or an active
ingredient for acne prone skins, it complements their action by reducing the
irritation of these altered skins.

SEPICALM S can also be used in concert with other soothing products such as alpha
bisabolol, glycyrrhetinic acid derivatives, allantoin, plant extracts (Aloe Vera,
Centella asiatica.) and seaweed extracts.

As examples, we propose formulas illustrating the numerous possible applications
of SEPICALM S:




                                         34
                     SOFTENING LOTION FOR SENSITIVE SKINS
                                    6662B

Formula

        •    MONTANOX 20 DF (Polysorbate 20 - SEPPIC)                                                   1.00%
        •    ORAMIX CG110 (Caprylyl/Capryl glucoside)                                                   2.00%
        •    Fragrance                                                                                  0.10%
        •    PEG-7 glyceryl cocoate                                                                     0.50%
        •    SEPICIDE HB (Phenoxyethanol/Methylparaben/Ethylparaben                                     0.30%
             /Propylparaben/Butylparaben - SEPPIC)
        •    SEPICALM S (Sodium cocoyl aminoacids & Sarcosine & Potassium                               3.00%
             aspartate & Magnesium aspartate)
        •    SEPICIDE CI (Imidazolidinyl urea - SEPPIC)                                               0.20%
        •    Water                                                                                  qs 100%

Procedure

Mix the ingredients in the order indicated before the introduction of water The final pH is
approximately 6.

Comments

SEPICALM S                A soothing lipoaminoacid active ingredient which is rich in minerals. It is
                          particularly suitable for sensitive skins and helps skin resist external aggressions of
                          a mechanical, chemical and actinic nature. It is hydrodispersible.

SEPICIDE HB/CI            A preservative system.

MONTANOX 20DF             A polysorbate which helps to solubilise the fragrance.

ORAMIX CG110              A non ionic mild surfactant of vegetable origin with excellent
                          dermocompatibility. The combination of polysorbate and ORAMIX provides
                          gentle cleansing effect and a very clear aspect overtime.

Characteristics


Appearance                Clear
pH                        Approximately 6
Viscosity                 <50 mPas
Stability                 Clear at room temperature/40°C
                          stable at +4°C

Notes

Fragrance: Rose rouge G9230806 (ROBERTET)




                                                     35
                           SOOTHING AFTER SHAVE BALM
                                     6663

Formule

 A     •   MONTANOV 202 (Arachidyl alcohol/behenyl                                      03.00 %
           alcohol/Arachidylglucoside - SEPPIC)
       •   SIMULSOL 165 (PEG-100 stearate/Glyceryl stearate - SEPPIC)                   02.00 %
       •   isononyl isononanoate                                                        05.00 %

 B     •   Isohexadecane                                                                15.00 %

 C     •   Purified water                                                            QSP 100 %
       •   SEPICALM S (Sodium cocoyl aminoacids & Sarcosine & Potassium                03.00 %
           aspartate & Magnesium aspartate - SEPPIC)


 D     •   SEPIGEL 305.(Polyacrylamide/C13-14 isoparaffin/Laureth-7 -SEPPIC)             02.50%

 E     •   SEPICIDE HB (Phenoxyethanol/Methylparaben/Ethylparaben                       00.30 %
           /Propylparaben/Butylparaben - SEPPIC)
       •   SEPICIDE CI (Imidazolidinyl urea - SEPPIC)                                   00.20 %
       •   Fragrance                                                                    00.30 %

Procedure

Melt part A at 80-85°C in a double jacketed tank(Do not prolong heating). Heat part C at 80-85°C.
Introduce B to A just before émulsifying A + B into C at 80-85°C. Add part D at 70°c .The cooling
process should be progressive to avoid recristallisation of MONTANOV 202. At around 40°C introduce
part E .

Comments:

MONTANOV 202            Glucolipid emulsifier from vegetable origin. Excellent co-emulsifier to use
                        with esters of ethoxylated fatty acids or fatty acids alone. Produce very
                        smooth emulsions with evanescent feel, easy spreading, and penetrate
                        quickly after application leaving a soft feeling and matted appearance.

SIMULSOL 165            Self emulfifying base.The combination of SIMULSOL 165 and MONTANOV 202
                        provides very good emulfying properties. The ratio between SIMULSOL 165
                        and MONTANOV 202 is able to change the viscosity and also the feel on skin.

SEPICALM S              Soothing active complex with lipoamino acid enrich with minéral salts
                        designed for sensitive skin . It protects the skin from external agression.

SEPIGEL 305             Emulsifiyng and thickening agent in a liquid form, very easy to handle (No
                        needs of pre-dispersion or neutralization).

SEPICIDE HB / CI        Preservative system.




                                                36
Characteristics:

Aspect                  White shiny cream
pH                      around 6
Viscosité               100 ,000 mPa.s BROOKFIELD LVT M4V6.
Stabilité               stable at RT/40/50°C
                        stable after freeze thaw cycles (-5°C/+40°C)
                        stable after centifuging at 50°C

Notes:

Perfume: Vent d'O X010.219.(QUEST)




                                                 37
             AHA DERMOPROTECTIVE GEL FOR SENSITIVE SKINS
                              6735


Formula

 A     •   Aqua/Water                                                                     70.00 %
       •   Carboxymethethyl cellulose                                                      0.70 %

 B     •   Lactic acid                                                                     2.00 %
       •   Sodium PCA (50%)                                                                0.30 %
       •   SEPICALM S (Sodium cocoyl aminoacids & Sarcosine & Potassium                    0.50 %
           aspartate & Magnesium aspartate - SEPPIC)


 C     •   Isononyl isononanoate                                                           3.00   %
       •   Cyclomethicone                                                                  2.00   %
       •   Glycereth-7 triacetate                                                          2.00   %
       •   MICROPEARL M305 (Methylmethacrylate crosspolymer - SEPPIC)                      1.00   %

 D     •   SIMULGEL EG (Sodium acrylate/Sodium acryloyldimethyltaurate                     5.00 %
           copolymer and Isohexadecane and Polysorbate 80 - SEPPIC)


 E     •   SEPICIDE HB (Phenoxyethanol/Methylparaben/Ethylparaben                          0.30 %
           /Propylparaben/Butyl paraben - SEPPIC)
       •   SEPICIDE CI (Imidazolidinyl urea - SEPPIC)                                      0.20 %
       •   Fragrance                                                                       0.20 %

       •   Aqua/Water                                                                    QS 100%
       •   Sodium Hydroxyde (32%)                                                          qs pH


Procedure

Disperse the CMC into the water using defloculating equipment. Then add the ingredients of B.
Prepare phase C separately, then disperse the SIMULGEL EG into this phase. Then add [C+D] into [A+B].
Thoroughly homogenise this mixture until a smooth gel is obtained then add the ingredients of E.
When the procedure is finished adjust the water content and the pH.




                                                 38
Comments

SEPICALM S               A lipoaminated, soothing active ingredient which is rich in minerals. It is
                         specially adapted to meet the needs of sensitive skins and helps resist
                         external agressions of mechanical, chemical (AHA) and actinic origin.

MICROPEARL M305          A texture additive which gives a satin, powdery feel to the formula.

SEPICIDE HB/CI           A preservative system.

SIMULGEL EG              A thickening, emulsifying agent which comes in a liquid, easy to use form.


Characteristics

Appearance               Opaque gel
pH                       Approximately 5
Viscosity                Approximately 50000 mPa.s BROOKFIELD LV S4 - 6 r.p.m.
Stability                Excellent a room temperature, 40°C and 50°C
                         stable during freeze/thaw cycles (-10°C/+40°C / 1month)
                         stable after centrifuging (3000rpm - 50°C - 20')



Assessment

Tested on volunteers , 6735 exhibits an excellent skin tolerance (ref DERMSCAN 99116.3)



Notes

Fragrance: NINA X018.434 (QUEST)
Carboxymethylcellulose: BLANOSE 7H4XF (AQUALON)
Glycereth 7 triacetate: PELEMOL G7A (PHOENIX)
Cyclomethicone: DC345 (DOW CORNING)




                                                  39
CONCLUSION :

By specifically inhibiting the main mediators responsible for
irritation when skin is under stress. SEPICALM S soothes sensitive
and fragile skins. Its radical scavenging, anti-elastase, anti-
hyaluronidase, anti-lipoxygenase activities have been proved in vitro.

SEPICALM S effectiveness has also been was proven in vivo. It helps
the skin combat solar, chemical and mechanical attacks. Moreover,
because of its moisturising power, SEPICALM S improves the state of
aggressed irritated skins.




                                  40
                                  REFERENCES

(1) Potassium, Council Regulation (EEC), 2377/90 - Article 7.

(2) B. Idson, "Trace minerals in cosmetics, Physiology and potential uses;
    Part II", D.C.I., p.37, May 1990.

(3) M. G. Tucci, G. Ricotti, G. Biagini et al, "Skin and Ageing : a morpho -
    spectrometric study", J. Appl. Cosmetol., 13, p.21-26, January - March 1995.

(4). Report IEC n° R60519ME

(5) Report DERMSCAN n° 96210-bis.

(6) Report IEC n° R60771E

(7) Report DERMSCAN n° 96267-bis.

(8) La Recherche 228 ; vol 22 ; p. 56 (Janvier 1991).

(9) Report interne - Activité antiradicalaire de SEPICALM® S

(10) R. Voegeli et al, « Elastase and tryptase determination on human skin
surface », Cosmetic & Toiletries magazine; vol 111 ; p. 51 (July 1996).

(11) V. Bizot -Foulon et al, « Inhibition of human neutrophil elastase by wheat
ceramides », International Journal of cosmetic Science, vol 17, p. 255 (1995).

(12) Internal Report - Activité anti élastase de SEPICALM ® S

(13) Reports BIOPREDICT n°2746/RF2.

(14) Reports BIOPREDICT n°2454/RF3.

(15) IEC, report n° R60346 D.

(16) SEPPIC Tox HETCAM 1067 a

(17) IEC n°70168RD7

(18) IEC n°80636RD




                                          41
Nota

The analytical specifications warranted are only those mentioned on the certificate of analysis supplied
with each delivery of the product.

Except as set forth above, SEPPIC* makes no warranties, whether express, implied or statutory, as to
the product which is the subject of this document . Without limiting the generality of the foregoing,
SEPPIC* makes no warranty of merchantability of the product or of the fitness of the product for any
particular purpose. Buyer assumes all risk and liability resulting from the use or sale of the product,
whether singly or in combination with other goods. The information set forth herein is furnished free of
charge and is based on technical data that SEPPIC* believes to be reliable. It is intended for use by
persons having technical skill and at their own discretion and risk. Since conditions of use are outside
SEPPIC*'s control, SEPPIC* makes no warranties, express or implied, and assumes no liability in
connection with any use of this information. Nothing herein is to be taken as a license to operate under
or a recommendation to infringe any patents.


* SEPPIC being:                 and, depending on the country :

SEPPIC S.A.                     SEPPIC UK Ltd                      SEPPIC ITALIA Srl
75, quai d’Orsay                50 Salisbury Road                  Via Quarenghi 27
75321 Paris cedex 07            PO Box 338 - Hounslow              20151 Milano
FRANCE                          TW4 6SH - ENGLAND                  ITALY
Tel. : +33 (0) 1 40 62 55 55    Tel. : +44 208 577 8800            Tel. : +39 02 38009110
Fax : +33 (0) 1 40 62 52 53     Fax : +44 208 570 2106             Fax : +39 02 38009140

                                SEPPIC Inc.                        SEPPIC Shanghai
                                30, Two Bridges Road, suite 210    Room 303 Li Hua Fu Xing Commercial Build
                                Fairfield, New Jersey 07004-1530   139 Rui Jin Yi Road
                                USA                                Shanghai 200020 CHINA
                                Tel. : +1 973 882 5597             Tel. : +86 (21) 53 06 30 16
                                Fax : +1 973 882 5178              Fax : +86 (21) 53 06 86 81




                                              www.seppic.com

                                   Subsidiary of the AIR LIQUIDE group

                                                                   C/1832/GB/01/OCTOBER 2001




SEPICALM™ S : A registered trade mark of SEPPIC




                                                          42

				
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Description: SEPICALM S Sodium-PCA