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Position
Paper of the GD
GD
adopts additional Guideline
Dermocosmetics
for the Cleansing of Dry Skin
In the department Dermocosmetics of the Gesellschaft für Dermopharmazie
(Society for Dermopharmacy) dermatologists, pharmacists, industry representatives
and other experts work together aiming at developing of interdisciplinary
concepts fit for consensus concerning cosmetic formulations of questions.
Thus the department has taken over, among others, the task to establish
guidelines with minimal requirements concerning quality and documentation
of dermocosmetics. After the publication of the guidelines "Dermocosmetics
for the Care of Dry Skin" as first result of this work in 1999, at
present a supplement to these guidelines - "Dermocosmetics for the
Cleansing of Dry Skin"- has been adopted.
In the sense of the guidelines the notion dry skin designates a skin condition
characterized by a reduced quantity and/or quality of humidity and/or lipids.
Objectively the appearance of dry skin is characterized by roughness, scale
formation, dullness and/or a lack of elasticity, whereas as subjective symptoms
sensations of tension and itching may appear. Dry skin reacts more intensively
than the normal, not dry skin, to external chemical or physical noxae. The
causes for dry skin may be a defect of the barrier function of the horny
layer, a reduced sebaceous gland activity and/or a reduced water binding
capacity.
The
guidelines "Dermocosmetics for the Cleansing
of Dry Skin" (see below) are the second guidelines elaborated
as consensus paper by members of the department Dermocosmetics of
the Gesellschaft für Dermopharmazie (GD) in addition to the guidelines
"Dermocosmetics for the Care of Dry Skin". Both position
papers can be looked up in the GD-homepage (www.gd-online.de).
In March of this year, the GD presented a Certification Procedure
for Products coming up to the stipulations of the guidelines. |
Dermocosmetics are defined in the guidelines as cosmetic products, the purpose
of application of which is achieved under co-consideration of dermatological
and pharmaceutical aspects. The dermocosmetics offered for the cleansing
of dry skin are to feature a good skin tolerance at a sufficient cleansing
effect and application frequency as usual for the product. For examination
and assessment of the skin tolerance, methods are recommended entailing
relevant, reproducible and valid results. In case, for example, an increase
of the fat or humidity content, a stabilization or improvement of the barrier
function, a skin smoothing or a different care effect is attributed besides
the cleansing, then also this additional benefit is to be proven by means
of suitable methods. For details of the study design it is referred to relevant
expert literature, quoted in the guidelines.
The complete information, required for the assessment of a dermocosmetic
for the cleansing of dry skin, should be documented by the producer respectively
seller of the product and made accessible to the experts. The documentation
should at least contain a description of the galenic system, indications
as to the shelf life and microbiological stability, the proof of the attributed
additional effects and the results of the tolerance examinations performed.
Guidelines
" Dermocosmetics for the Cleansing of Dry Skin" in the version
of 22 January 2001
Contents
1
Preamble
The
general purpose of skin cleansing is to remove soiling, excessive skin
parts (skin scales, sweat, sebum), unwanted micro organisms and their
metabolic products as well as possibly existing residues of medicinal
or cosmetical preparations from the skin surface. A product recommendation
should only be given if certain quality standards are ensured, i.e. if
galenic properties, wanted and unwanted effects are sufficiently investigated
and documented. So far a standardized, interdisciplinarily harmonized
concept has not been established. This is why the department Dermocosmetics
of the GD Gesellschaft für Dermopharmazie e.V. (Society for Dermopharmacy)
as independent organization undertakes to lay down minimal requirements
regarding quality and documentation in the form of the present guidelines.
These guidelines are intended to be a support for all those who are concerned
with dermocosmetics for the cleansing of dry skin.
They are a systematically elaborated recommendation offering an orientation
to the target group when making decisions about adequate measures for
the cleansing of dry skin and have been established by an interdisciplinary
expert group by evaluating relevant international literature.
They apply to "standard situations" taking into consideration
the current scientific findings available for the corresponding questions.
The guidelines require permanent revision and if necessary modifications
founded on scientific findings and the practicability in daily practice.
Consideration of the guidelines does not ensure in every case the achieving
of the objective strived for. It does not lay claim for completeness.
2 Definition
of Dermocosmetics
The
term "Dermocosmetics" designates measures for the care, protection
and cleansing of skin for which the application purpose is achieved under
co-consideration of dermatological and pharmaceutical aspects. Cosmetical
products coming up to these demands are defined as "Dermocosmetics".
Dermocosmetics for the Cleansing of Dry Skin
Dermocosmetics for the cleansing of dry skin are such products for
which their intended purpose "for dry skin" or "application
for dry skin" is indicated.
They are to feature a good skin tolerance at a satisfactory cleansing
effect and an application frequency as usual for the product type. An
existing dryness of skin should not be intensified by a regular application.
As all cosmetical products, dermocosmetics for the cleansing of dry skin
are also subject to the Cosmetics-guidelines of the European Community.
Legal basis in the Federal Republic of Germany is the Lebensmittel- und
Bedarfsgegenständegesetz (Food and Consumer Good Act) in combination
with the Cosmetics-decree, in Austria the Lebensmittelgesetz (Food Act)
in combination with the Cosmetics-decree and in Switzerland the Lebensmittel-
und Gebrauchsgegenstände-Gesetz (Food and Consumer Durables Act)
with the decree about cosmetic products in the respectively valid versions.
3 Target
Group and Purpose
Target
group of these guidelines are persons developing, producing, testing,
analysing, commercializing, giving advice as to the application, selling
dermocosmetics as well as consumers.
These guidelines are a systematically elaborated representation and recommendation.
They describe quality standards relating to the products and offer support
in the decision for measures as to the cleansing of dry skin to the persons
indicated above.
4
Definition of Dry Skin
The
term dry skin (xerosis, xerodermia) describes a skin condition which is
characterized by a reduced quantity and/or quality of humidity and/or
lipids. Objectively the appearance of dry skin is characterized by roughness,
scales, dullness and/or a lack of elasticity. Subjectively a sensation
of tension and itching may appear with dry skin. These subjective symptoms
can also manifest isolatedly.
Dry skin in the sense of these guidelines is to be understood as a symptom
and not an isolated clinically defined dermatosis, as for instance dermatitis,
psoriasis or ichthyosis.
Dry skin reacts more intensely than normal, not dry skin, to external
chemical and physical noxae.
According to expert opinions dry skin appears very frequently; only in
Germany several million people are affected. Epidemiological data are
not available.
The exact aetiopathogenesis of dry skin is still open. Persons being inclined
to atopy have a defect of the barrier function of the horny layer of the
epidermis which can result in a transepidermal waterloss. Mainly the horny
layer lipids (1-3) are lacking. Dry skin can however also be caused by
a sebostasis (reduced sebaceous gland activitiy) (4). Equally a reduced
water binding capacity can be the case.
Causes and development:
Dry skin is either genetically conditioned or acquired. It appears as
a symptom of a skin disease, e.g. of the atopical dermatitis (5), an internal
disease, e.g. a pyeolopathy (6) or the diabetes mellitus (7). Dry skin
can also be caused by exterior influences, as for instance by having showers
or baths too frequently and intensively with or without using soaps or
syndets (8 - 11). In addition, occupational strains, e.g. when exercising
"humid professions" (hairdressers, etc.) as well as occupations
in the construction and metal processing trade (12) may cause the emergence
of dry skin. This equally applies to climatic factors as cold or low atmospheric
humidity (13).
Diagnostics:
Statements of persons concerned lead to the diagnosis of dry skin and
in addition a visual and palpatoric examination. Apparative diagnostical
methods are among others: measurements of skin roughness (5, 14, 15),
moisture content (16-18), determination of the transepidermal waterloss
(19, 20), fat content (1) and scale formation (22) as well as the measurement
of skin glossiness (23).
5
Formulations and Ingredients
The properties of dermocosmetics for the cleansing of dry skin are attached
to the overall formulation.
Scientific findings allow in principle different formulation types for the
cleansing of dry skin which are attributed to the washing, having showers
or baths. In this context preparations on surfactant basis prevail (soaps
in the form of bars or liquids and syndet preparations, the latter are for
example designated as washing emulsion, washing lotion, washing gel, shower
bath, foam bath). These products partly contain additional lipid components
for the purpose of fat restoring in skin. They are for instance indicated
as shower creams or oils or hand washing creams or oils. Oil baths for the
cosmetical application are available containing emulsifiers (emulsion baths)
and as emulsifier-free preparations (spreading baths). The latter are predominantly
applied for the purpose of skin care. For the facial use there are equally
cleansing agents containing surfactants (e.g. cleansing milks) and surfactant-free
cleansing agents (e.g. facial cleansing oils) available. For special purposes
(e.g. in peeling preparations and hand washing pastes) cleansing products
contain additionally rubbing agents. Besides for the cleansing of the face,
body and hands, cleansing tissues on the basis of oils, emulsions, surfactants
and/or solvents are obtainable.
It should have been proven for dermocosmetics for the cleansing of dry skin
that the barrier function, the water binding capacity and the physiological
pH-environment of the horny layer is impaired as little as possible. An
essential influence in this connection mainly has the selection and the
mixing ratio of the surfactants applied.
Further special properties (e.g. fat restoring or other care effects) by
special features of the formulation or additives of special ingredients
should be proven by appropriate in-vivo methods according to the respective
latest scientific findings.
6
Wanted effects and Effectiveness Proofs
The attribution of a skin cleansing effect only requires a separate proof
if the product serves a special purpose, e.g. facial cleansing preparations
for the removal of decorative cosmetics. In the commercial field these
are hand cleansing preparations for the removal of heavy soilings by waste
oil, varnish, adhesives, etc.
For an assessment of the cleansing effect of individual preparations,
standardized wash tests simulating the washing process can be performed
(24 - 26). Basis of the effectiveness proof is on the one hand a comparison
with skin areas which are only cleaned with water and on the other hand
a comparison with the starting value, i.e. the value before the washing
process (intra-individual comparison).
An
additional benefit for the cleansing may among others lie in an increase
of the fat or moisture content, a maintaining or amelioration of the barrier
function or a skin smoothing. For the evidence of such effects, the methods
indicated for diagnostics are applicable (refer to chapter "Definition
of dry Skin"). These measuring methods are suitable as far as they
supply relevant, reproducible and valid results and correspond to the
respective status of scientific findings.
For a proof of the cleansing effect as well as for the detection of additional
care effects, the respective study design has to be chosen in a way that
the number of test persons is sufficiently high for the selection of adequate
statistical methods so that differences can be registered. For details
of the study design a reference is given to the relevant expert literature
(27, 28).
7
Unwanted Effects and Tolerance Proofs
Application risks of
dermocosmetical products for dry skin can be, as for other preparations
for topical application, intolerance reactions as the acute or chronical-cumulative
irritative contact dermatitis, sensoric irritations or allergic contact
dermatitis on the basis of a sensitization of the delayed reaction type.
Among these risks for skin cleansing agents, the chronic-cumulative irritative
contact dermatites are the most frequent skin diseases in this field (29).
In this connection, besides the composition also the dosage of the cleansing
preparations is important as well as frequency and duration of the washing
process and in addition the water temperature, the pH-value and the hardness
of water (30 - 32).
For
testing and assessment of the skin tolerance, appropriate in-vivo and
in-vitro methods can be applied (27, 33 - 37). Basis for these tests should
be the Notes of Guidance for the examination of the safety of cosmetic
preparations, annex 11 and 12 of the SCCNFP (8). The rest reactions can
be objectified by means of non-invasive skin physiological methods (39).
In combination and as complement, standardized washing and controlled
application tests (practical tests) can be performed (24 - 27, 35).
As method for the risk assessment of an acute irritation, the occlusive,
epicutaneous patch test is recommended (27, 35).
The chronical-cumulative irritation can be counted by means of the cumulative
epicutaneous patch test (40), the Duhring-chamber-test (1), the bend of
elbow washing test (42) as well as the forearm washing test (43).
For examining of the sensoric irritation there are procedures in place,
making use of the triggering of a comparable stabbing sensation by organic
acids, e.g. sorbic acid or lactic acid (44).
For the recording of the sensitization potential of dermocosmetics for
the cleansing of dry skin, at present no validated and ethical generally
accepted methods are available. Alternatively it is recommended to make
a thorough selection of raw materials and to avoid the use of for example
known allergens with a comparably high sensitization potential (for example
[45]) known from relevant publications.
For the tolerance proofs the information regarding the study design given
in chapter "Wanted Effects and Effectiveness Proofs" is also
to be adhered to.
8
Documentation
Information necessary
for the quality assessment of dermocosmetics for the dry skin cleansing
is to be documented and made accessible to the experts by the manufacturer
respectively seller of the preparation.
This documentation
should at least contain information as to the following subjects:
|
Description
of the galenic system if so possible with the indication of the share
of surfactants and when attributing a fat-restoring effect additionally
the share of lipids as well as the pH-valuees |
|
Indications
relating to the shelf life and microbiological stability
|
|
For special preparations for heavy soiling a proof of the cleansing
effect
|
|
Proof
of additional effects subject to attribution in the form of a summarizing
description and indication of references |
|
Summary
of results for the performed tolerance tests and indication of the
test institution |
9 References
(1)
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corneum of atopic dermatitis: An etiologic factor in atopic dry skin?
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composition of the skin of patients with atopic dermatitis. Acta Derm.
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manifestations in IDDM patients and their association with diabetes risk
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(11) Bechor R., Zlotogorski A., Dikstein S.: Effect of soap and detergents
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(14) Rohr M., Schrader K.: Fast optical in vivo topometry of human skin
(FOITS) - Vergleichende Untersuchungen zur Laserprofilometrie. SÖFW 2,
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Oberflächenstruktur der Haut (SELS) Akt. Dermatol.23, 290 -295, 1997
(16) Wienert V., Hegner G., Sick H.: Ein Verfahren zur Bestimmung des
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Dermatol. Res. 270, 67-75, 1981
(17) Fluhr J.W., Gloor M., Lazzerini S., Kleesz P., Grieshaber R., Berardesca
E.: Comparative study of fine instruments measuring stratum corneum hydration
(Corneometer CM 820 and CM 825m Skicon 200, Nova DPM 9003, DermaLab) Part
I. In vitro. Skin Research and Technology 5, 161-170, 1999
(18) Fluhr J.W., Gloor M., Lazzerini S., Kleesz P., Grieshaber R., Berardesca
E.: Comparative study of fine instruments measuring stratum corneum hydration
(Corneometer CM 820 and CM 825m Skicon 200, Nova DPM 9003, DermaLab) Part
II. In vivo. Skin Research and Technology 5, 171-178, 1999
(19) Pinnagoda J., Tupker R.A., Serup J.: Guidelines for transepidermal
waterloss (TEWL) measurement. Contact Dermatitis 22, 164-178, 1990
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by transepidermal water loss measurements: Comparison between two commercial
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1995
(21) Dikstein S., Zlotogorski A., Avriel E., Katz M., Harms M.: Comparison
of the Sebumeter® and the Lipometre Ò. Bioengineering and the Skin,
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(22) Serup J., Winther A., Blichmann C.: A simple method for the study
of scale pattern and effects of moisturizer - qualitative and quantitative
evaluation by D-squame tape compared with parameters of epidermal hydration.
Clin. Exp. Dermatol. 14, 277-282, 1989
(23) Lentner A., Wienert V.: A new method for assessing gloss of human
skin. Skin Pharmacol. 9, 184-189, 1996
(24) Gehring W., Geier J., Gloor M.: Untersuchungen über die austrocknende
Wirkung verschiedener Tenside. Dermatol Monschr 177, 257-264, 1991
(25) Tronnier H., Kresken J., Jablonski K., Komp B.: Haut und Beruf. Strategien
zur Verhütung berufsbedingter Hauterkrankungen. Grosse Verlag Berlin 1989
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In: Braun-Falco O., Glorr M., Korting H.C.: Nutzen und Risiko von Kosmetika.
Springer Verlag, Heidelberg 2000
(27) Matthies W.: Dermatologische Testmethoden zur Bewertung der lokalen
Verträglichkeit von Fertigprodukten - Die neue COLIPA-Guideline als Beitrag
zur Sicherheitsbewertung kosmetischer Mittel gemäß 6. Änderungsrichtlinie
der EU-Kosmetik-Richtlinie. Dermatosen 45, 154-159, 1997
(28) Schrader K.: On the Problems of In Vivo Cleansing of the Human Skin.
In: Elsner P, Merk HF, Maibach HI (Hrsg.): Cosmetics. Controlled Efficacy
Studies and Regulation, Springer, Berlin Heidelberg, New York, 1999, S.
92-106
(29) Wigger-Alberti W, Elsner P.: Contact Dermatitis due to Irritation.
In: Kanerva L, Elsner P, Wahlberg JE, Maibach HI (Hrsg.): Handbook of
Occupational Dermatology. Springer, Heidelberg 2000, S. 99-110
(30) Berardesca E., Vignoli G.P., Distante E., Brizzi P., Rabbiosi G.:
Effects of Water temperature on surfactant-induced skin irritation. Contact
Derm. 32, 83-87, 1995
(31) Gehring W., Gehse M., Zimmermann V., Gloor M.: Effecs of pH changes
in a specific detergent multicomponent emulsions on the water content
of stratum cormeum. J. Soc. Cosm. Chem., 42, 327-333, 1991
(32) Warren R., Ertel K.D., Bartolo R.G., Levine M.J., Bryant P.B., Wong
L.F.: The influence of hard water (calcium) and surfactants on irritant
contact dermatitis. Contact Derm. 35, 337-343, 1996
(33) de Brugerolle de Frasinette A., Picarles V., Chibout S., Kolopp M.,
Medina J., Burtin P., Ebelin M.E., Osborne S., Mayer F.K., Spake A., Rosdy
M., De Wever B., Ettlin R.A., Cordier A.: Predictivity of an in vitro
model for acute and chronic skin irritation (SkinEthicÒ) applied to the
testing of topical vehicles. Cell Bio. Toxicol. 15, 121-135, 1999
(34) Pittermann W.: Tierversuchsfrei forschen mit dem Rindereuter-Modell;
In vitro Haut- und Schleimhauttests im Focus kosmetischer Forschung. Parfümerie
und Kosmetik, 80, 38-41, 1999
(35) COLIPA: Cosmetic product test guidelines for the assessment of human
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York, 1997, pp 153-169
(37) Tausch I., Bielfeldt S., Hildebrand A., Gaßmüller J.: Validation
of a modified Duhring Chamber Test (DCT) as a repeated patch test. Parfümerie
und Kosmetik 77, 28-31, 1996
(38) The Scientific Committee on Cosmetic Products and non-food products
intended for consumers (SCCNFP): Notes of guidance for testing of cosmetic
ingredients for their safety evaluation. 3rd Revision. SCCNFP/0119/99
Final.
(39) Fischer T., Greif C., Wigger-Alberti W., Elsner P.: Instrumentelle
Methoden zur Bewertung der Sicherheit und Wirksamkeit von Kosmetika. Akt.
Dermatol. 24, 243-250, 1998
(40) Kligman A.M., Wooding W.M.: A method for the measurement and evaluation
of irritants on human skin. J. Invest. Dermatol. 49, 78-94, 1967
(41)Frosch, P.J., Kligman A.M.: The Duhring chamber. An improved technique
for epicutaneous testing of irritant and allergic reactions. Contact Dermatitis
5, 73-81, 1979
(42) Frosch P.J.: Irritancy of soap and detergent bars. In: Frosch P.,
Horwitz S. (Hrsg.) Principles of cosmetics for the dermatologist. Mosby,
St Louis, 1982, S 5-12
(43) Nicoll G.A., Murahate R.I., Grove G.L.: The relative sensitivity
of two arm wash test methods for evaluating the mildness of personal washing
products. J. Soc. Cosm. Chem. 46, 129 - 140, 1995
(44) Lammintausta K, Maibach HI, Wilson D: Mechanisms of subjective (sensory)
irritation. Propensity to non-immunologic contact urticaria and objective
irritation in stingers. Derm. Beruf Umwelt 36, 45-49, 1988
(45) Fiedler H.P., Ippen P., Kemper F.H., Lüpke N.P., Schulz K.H., Umbach
W. (Hrsg.): Blaue Liste. Inhaltsstoffe kosmetischer Mittel. 2.Aufl. Editio
Cantor Verlag, Aulendorf 1993
10
Elaborated by
|
Dr.
M. Arens-Corell, Sebapharma GmbH & Co., Boppard |
|
Dipl. Ing. Stephan Bielfeldt, Institut Bioskin, Hamburg |
|
Dr.
G. Blume, ROVI GmbH, Schlüchtern |
|
Prof.
Dr. R. Daniels, Institut für Pharmazeutische Technologie,Technische
Universität Carolo-Wilhelmina, Braunschweig |
|
Dr.
J. Gassmüller, Institut Bioskin, Hamburg |
|
Dr.
P. Hansen, Stada R & D GmbH, Bad Vilbel |
|
PD
Dr. U. Heinrich, Institut für experimentelle Dermatologie, Universität
Witten//Herdecke, Witten |
|
Apothekerin
U. Kindl, Margarethen-Apotheke, Baldham |
|
Dr.
J. Kresken, Irmgardis-Apotheke, Viersen |
|
Prof.
Dr. G. Kutz, Technologie der Kosmetika und Waschmittel, Fachhochschule
Lippe, Lemgo |
|
Dr.
W. Leven, Eimsbütteler-Apotheke, Hamburg |
|
Dr.
W. Pittermann, Henkel KGaA, Düsseldorf |
|
Dr.
F. Rippke, Beiersdorf AG, Hamburg |
|
Dr.
A. Schrader, Beratungslabor Dr. Schrader, Holzminden |
|
PD
Dr. N. Schürer, Fachbreich Physiologie und Gesundheitswissenschaften,
Universität Osnabrück) |
|
Dr.
S. Wallat, Cognis Deutschland GmbH, Düsseldorf |
|
Prof.
Dr. V. Wienert, Hautklinik der Medizinischen Fakultät, Rheinisch-Westfälische
Technische Hochschule, Aachen |
|
Dr.
W. Wigger-Alberti, Klinik für Hautkrankheiten, Friedrich-Schiller-Universität,
Jena |
The
guidelines have been established on behalf of the GD Gesellschaft für
Dermopharmazie (Society for Dermopharmacy) by the a.m. expert group as
consensus paper.
Released for publication: 22 January 2001
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