Guidelines "Dermocosmetics for the Cleansing of Dry Skin" (version of 22 January 2001)
|Target group and purpose|
|Definition of dry skin|
|Formulations and ingredients|
|Wanted effects and effectiveness proofs|
|Unwanted effects and tolerability proofs|
|Participants and experts concerned|
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 the target group an orientation 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. These guidelines require permanent revision and if necessary modifications founded on scientific findings and the feasibility 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 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 tolerability 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 preparations in the respectively valid versions.
3 Target group and purpose
Target group of these guidelines are persons developing, preparing, testing, analysing, commericializing, giving advice as to their application, selling as well as consumers.
These guidelines are a systematically elaborated representation and recommendation. They describe quality standards relating to preparations 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 marked 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 persons 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 too frequently and intensively or taking baths 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 metall processing trade (12) may cause the emergence of dry skin. This equally applies to climatic factors as cold or low atmospheric humidity (13).
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 emulsifiers (e.g. cleansing milks) and emulsifier-free cleansing
agents (e.g. facial cleansing oils) available. For special purposes (e.g. in
peeling preparations and hand washing pastes) cleansing agents contain additionally
rubbing agents. Besides for the cleansing of the face, body and hands, cleansing
tissues on the basis of oils, emulsifiers, 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 components 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 preparation 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 apt 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 probationers for the selection of adequate statistical methods is sufficiently high 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 tolerability proofs
Application risks of dermocosmetical preparations for dry skin can be intolerability reactions as acute or chronical-cumulative irritative contact dermatitis, sensoric irritations or allergic contact dermatitis on the basis of a sensitization of the delayed reaction type as for other preparations for topical application. 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 tolerability 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 making use of the releasing 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 ethically 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 ) known from relevant publications.
For the tolerability proofs the information regarding the study design given in chapter "Wanted Effects and Tolerability Proofs" is also to be adhered to.
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-value|
||Indications relating to the shelf life and microbiological stability|
||For special preparations for heavy soiling a proof of the cleansing effect|
||Evidence of additional effects subject to attribution in the form of a sum-marizing description and indication of references|
||Summary of results for the performed tolerability tests and indication of the test institution|
(1) Imokawa G., Abe A., Jin K. et al.: Decreased level of ceramides in stratum corneum of atopic dermatitis: An etiologic factor in atopic dry skin? J. Invest. Dermatol. 96, 523-526, 1991
(2) Di Nardo A., Wertz P., Gianetti H. et al.: Ceramide and cholesterol composition of the skin of patients with atopic dermatitis. Acta Derm. Venereol. 78, 27-30, 1998
(3) Melnik B., Hollmann J., Plewig G.: Decreased stratum corneum ceramides in atopic dermatitis individuals - a pathobiochemical factor in xerosis? Br. J. Dermatol. 119, 547-549, 1988
(4) Proksch E.: Die Permeabilitätsbarriere der Epidermis und ihre Beeinflussung durch Detergentien und Lokaltherapeutika. Ärztl. Kosmetol. 19, 424-434, 1989
(5) Linde Y.W., Bengston A., Loden M.: Dry skin in atopic dermatitis. A surface
profilometry study. Acta Derm. Venereol. 69, 315-319, 1989
(6) Morton C.A., Lafferty M., Hau C. et al.: Pruritus and skin hydration during dialysis. Nephrol. Dial. Transplant. 11, 2031-2036, 1996
(7) Yosipovitch G., Hodak E., Vardi P. et al.: The prevalence of cutaneous manifestations in IDDM patients and their association with diabetes risk factors and microvascular complications. Diabetes Care 21, 506-509, 1998
(8) Gammel C.E., Pagnoni A., Kligman A.M., el Gammal S.: A model to assess the efficacy of moisturizers - the quantification of soap-induced xerosis by image analysis of adhesive coated discs. Clin. Exp. Dermatol. 21, 338-343, 1996
(9) Gfatter R., Hackl P., Braun F.: Effects of soap and detergents on skin surface pH, stratum corneum hydration and fat contents in infants. Dermatology 195, 258-262, 1997
(10) van der Falk P.G., Cryns M.C., Nater J.P.: Skin irritancy of commercially
available soap and detergent bars as measured by water vapour loss. Clin. Exper.
Dermatol. 10, 98-103, 1984
(11) Bechor R., Zlotogorski A., Dikstein S.: Effect of soap and detergents on the pH and casual lipid levels of the skin surface. J. Appl. Cosmetol. 6, 123-128, 1988
(12) Svendjen K., Hilt B.: Skin disorders in ship's engineers exposed to oils and solvents. Contact Dermatitis 36, 216-220, 1997
(13) Eberlein-König B., Spiegl A., Przybilla B.: Change of skin roughness due to lowering air humidity in a climate chamber. Acta Derm. Venereol. 76, 447 - 449, 1996
(14) Rohr M., Schrader K.: Fast optical in vivo topometry of human skin (FOITS) - Vergleichende Untersuchungen zur Laserprofilometrie. SÖFW 2, 3-8, 1998
(15) Tronnier H., Wiebusch M., Heinrich U., Stute R: Zur Bewertung der Oberflächenstruktur
der Haut (SELS) Akt. Dermatol.23, 290 -295, 1997
(16) Wienert V., Hegner G., Sick H.: Ein Verfahren zur Bestimmung des relativen Wassergehaltes des Stratum corneum der menschlichen Haut. Arch. 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
(20) Barel A.O., Clarys P.: Study of the stratum corneum barrier function by transepidermal water loss measurements: Comparison between two commercial instruments: Evaporimeter® and Tewameter®. Skin Pharmacol. 8, 186-195, 1995
(21) Dikstein S., Zlotogorski A., Avriel E., Katz M., Harms M.: Comparison of the SebumeterÒ and the Lipometre Ò. Bioengineering and the Skin, 3/2, 197-207, 1987
(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
(26) Schrader K.: Wirkungen und Nebenwirkungen gewerblicher Handreinigungsmittel. 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 skin compatibility. 1995
(36) Muhrahata RI, Nicoll GA: Mildness testing for personal washing products. In: Aust LB (ed) Cosmetic Claims Substantiation. Marcel Dekker Inc. New 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
and experts concerned
||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, Hautarztpraxis, Würzburg|
||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 Dermo-pharmazie e.V. (Society for Dermopharmacy) by the a.m. expert group as consensus paper.
Released for publication: 22 January 2001
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