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  Issue 1 (2005)

Guideline of the Society for Dermopharmacy

Dermocosmetics for the Cleansing and Care of Skin Prone to Acne

1 Preamble
2 Definition of dermocosmetics
3 Target group and objective
4 Definition of skin prone to acne
5 Formulations and ingredients
6 Wanted effects and effectiveness proof
7 Unwanted effects and tolerance proof
8 Documentation
9 Literature
10 Processes for achieving of consensus

1 Preamble

The department Dermocosmetics of the GD Gesellschaft für Dermopharmazie has undertaken the task as independent organization of stipulating minimal requirements for dermocosmetics in view of quality and documentation in the form of guidelines. Thus in April 2003 the guideline "Dermocosmetic Sun Protection", in February 2000 the guideline "Dermocosmetics for the Care of Dry Skin" and in January 2001 the guideline "Dermocosmetics for the Cleansing of Dry Skin" were published.

The two latter guidelines were updated by the summarized guideline "Dermocosmetics for the Cleansing and Care of Dry Skin" in 2003. The present guideline for products which are attributed for the cleansing and care of skin prone to acne is to represent a recommendation in view of quality and documentation of these products.

The so-called impure skin affected by acne requires special measures for cleansing and care due to its structural and functional peculiarities. The skin cleansing and care products used are to reduce the excess of sebaceous gland lipids on the skin surface, diminish the population with acne-relevant bacteria as well as possibly exert positive influence on inflammations thus contributing to the re-establishing of a normal skin condition.

This differs from the concomitant care of severe acne forms requiring dermatological therapy which on its part evolves a desiccating and irritative effect (for example by systemical retinoids). The corresponding care is not part of this guideline.

Recommendable are only such products coming up to certain quality requirements. Thus particularly galenical properties as well as wanted and unwanted effects should be sufficiently tested and documented. For a realization of these standards there was no consistent and interdisciplinary coordinated concept available to date.

This guideline is intended to serve as support for all those who are concerned with dermocosmetics for the cleansing and care of skin affected by acne. It is a recommendation offering an orientation guide to this target group in decisions regarding development and testing as well as appropriate application of dermocosmetics for the cleansing and care of skin prone to acne. It has been elaborated by an interdisciplinary expert group by incorporating relevant international literature.


2 Definition dermocosmetics

The Gesellschaft für Dermopharmazie e. V. defines as dermocosmetics such cosmetic products for which the cosmetic purpose of application under co-consideration of dermatological and pharmaceutical aspects is achieved. Since such cosmetic agents are also applied supportively respectively concomitant to a therapy as well as for the prevention from skin diseases they are to fulfil certain demands in view of their quality and documentation.

Dermocosmetics for the cleansing and care of skin tending to acne.

Dermocosmetics for the cleansing and care of skin affected by acne are such products for which the purpose "skin affected by acne" or "for impure skin" is specified. They are to possess a good skin tolerance at this special skin condition as well as sufficient cleansing respectively care effect at usual product application frequency.

The cleansing of the skin serves in general the objective to remove or reduce soiling, excessive skin components, unwanted micro-organisms and their metabolic products as well as possibly existing residues from medicaments or cosmetics from the skin surface. Skin cleansing agents for skin tending to acne are to diminish the present excess of sebaceous gland lipids and decrease the population of acne-relevant bacteria without causing or enhancing irritations and without impairing the skin barrier.

The care of skin affected by acne is an essential part of the prophylaxis as well as a major concomitant measure in the course of and after a dermatological therapy. The care products used should not interfere with the parallelly used acne therapeutics but ideally counter possible therapy-related side effects.

As all cosmetic products, dermocosmetics for the cleansing and care of skin prone to acne are equally subject to the European Union's cosmetics guideline. Legal basis in the Federal Republic of Germany is the Foodstuffs and Commodities Act in combination with the Cosmetics Decree, in Austria the Food Law together with the Cosmetics Decree and in Switzerland the Foodstuffs and Commodities Act jointly with the Decree relating to Cosmetic Products in their respectively valid versions.


Target group and purpose

Target group of this guideline are persons developing, producing, testing analyzing or marketing dermocosmetics for the cleansing and care of skin affected by acne as well as giving advice to their application and dispensing them.

This guideline is a presentation and recommendation and has been established by an expert committee under consideration of pertinent literature. It describes quality requirements to products and offers decision support for the realization of their tasks to the aforementioned persons.


4 Definition of skin prone to acne

So-called impure skin and predisposition to acne belong to the pattern Acne vulgaris. The term Acne vulgaris describes a skin condition which is characterized by papules, pustules, open and/or closed comedos as well as seborrhoea (excessive lipid production).

Skin tending to acne in the sense of this guideline is understood as a symptom complex at which the skin is subject to an increased formation of sebum lipids and a bacterial population as well as a possible (consecutive) inflammatory alteration.

Objectively, the appearance of skin tending to acne is marked by a greasy skin surface, increased gloss as well as in parts by inflammatory changes. In the aftermath, irreversible scars may develop from acne efflorescence. Skin tending to acne is a very frequent skin condition, especially in the juvenile age as well as with young adults.

The prevalence of acne in literature is indicated with 70 to 85 percent with a slightly higher frequency for males [1-5]. As risk factors a genetic predisposition and smoking have been identified [1, 5]. In this context it is also referred to the guideline relating to acne by the Deutsche Dermatologische Gesellschaft (German Dermatologic Society).


The etiopathogenesis of skin affected by acne encompasses an increased production by sebaceous gland lipids, based on a hormonal imbalance and a hypersensitivity to hormone receptors, a disturbed follicular differentiation und hyperkeratosis, a bacterial population (by propioni-bacteria and Staphylococcus aureus) of the infundibulum, an inflammatory reaction as well as environmental and genetic factors [6]. At improper use, cosmetic products themselves, in particular intensely greasing formulations or products with intrinsic comedogenic self-effect may entail a so-called cosmetic acne [7-14].

Evaluation of skin condition

Normally, skin prone to acne is determined by the subjective sensation of the person affected as well as by visual and palpatoric statement [15]. For the clinical graduation numerous techniques and schematics have been developed [15-20]. Acne lesions are divided according to their clinical aspect into open and closed comedos (blackheads) as well as papules and pustules. The greasy or glossy skin surface represents the central problem for the cleansing and care or skin prone to acne. An objectification may be effected both by a visual score and - in particular in the course of experimental-clinical studies by means of biological, biochemical and physical test methods [6, 18, 21]. Complementary, limitations of the psycho-social quality of life are quantitatively determined and considered for the assessment of therapeutical measures [16, 22].


5 Formulations and ingredients

Properties of dermocosmetics for the cleansing and care of skin affected by acne are connected to the overall formulation and not to individual ingredients. Attention is to be paid for skin tending to acne that the final product is adjusted to the special skin condition [23, 24].

Dermocosmetics for the cleansing of skin prone to acne

It should be proven for dermocosmetics offered for the particular use of cleansing skin tending to acne that they reduce the skin surface lipids (especially sebaceous gland lipids) and/or diminish the bacterial population. Moreover, skin cleansing products may exert a positive influence on the inflammatory reaction. An essential impact have in this regard selection and mixing ratio of the surfactants, alcohols and other auxiliaries and active agents employed. If for a product - based on its formulation or the addition of special ingredients - properties such as reduction of surface lipids (or care effect) are claimed then these should be proven by means of suitable in-vivo methods according to the current state-of-the art of scientific insights.

As a disturbance of the barrier function of the skin is often the case, it is to be ensured that mild cleansing products are applied. The washing formulation is not to impair the physiological ph-value of the skin [25, 26].

Dermocosmetics for the care of skin prone to acne

The scientific state of knowledge allows for the care of skin affected by acne in relation to the skin condition basically various formulation types (for example hydro gels, gel creams, creams).

Moreover, skin prone to acne oftentimes requires moisturizing products: in general these should be hydrophilic and non-greasy. As the barrier function of skin may be affected, light, non comedogenic emollients may be used [27] as well.

Employed for dermocosmetics for the care of skin prone to acne are also keratolytic effective ingredients such as alpha hydroxy acids, salicylic acid, lipohydroxy acid and retinaldehyde [28-33]. Furthermore, the application of peeling methods and masks may be useful for this skin condition.


6 Wanted effects and
effectiveness proof

Dermocosmetics for the cleansing of skin prone to acne

The claim of a skin-cleansing effect only requires a separate proof if the product serves a special purpose. This applies in particular for facial cleansing preparations for the removal of excessive sebum from the skin surface.

Standardized washing tests may be performed [34-38] for the assessment of the cleansing effect of individual products simulating the facial wash process. The effectiveness proof is either performed by comparison with skin areas which are merely washed with water or remain untreated, and by comparison with the starting value before the wash process (intra-individual comparison).

A statistically relevant number of probands with skin prone to acne is to be included in the respective study design. The same principles apply to details concerning the study design as for the proof of care effects (see below).

Dermocosmetics for the care of skin prone to acne

The attribution of a general care effect does not require a separate proof. Special effects such as a regulation of the skin surface lipids (in particular sebaceous gland lipids) and the favourable impact on non-inflammatory and inflammatory acne efflorescences [39], have to be proven by specific scientific tests. The following designs may form the basis for effectiveness proofs:

  • Intra-individual comparison between treated and untreated areas affected (for example half-side tests);
  • Baseline-adjusted lesion count in chronological course;
  • Placebo-controlled comparison of two groups.

Special attention is to be paid to sufficient application duration according to the attributing claim as well as a sufficiently high case number (according to the corresponding power calculation).

The test methods as indicated in chapter 4 (assessment of skin condition) are qualified as examination methods provided that they furnish relevant, reproducible and valid results regarding the respective question. The study design is to be chosen in a way that there is a sufficiently high number of probands for the application of suited statistical methods to achieve indication to distinctions. Please refer for details to specialized literature [40].


7 Unwanted effects and
tolerance proofs

Risks for the application of dermocosmetics for the cleansing and care of skin prone to acne may be incompatibility reactions as acute or chronical - cumulative irritative contact dermatitis, sensoric irritations or allergenic contact dermatitis on basis of a sensitization of the delayed type comparable to other products for external application. There is a reference available that contact sensitization at acne patients, possibly related to the protective properties of the sebum [41], appear less frequently [42] in comparison to others, in particular with skin conditions connected to a limited barrier function.

For the testing and assessment of the skin tolerance of products suited in-vivo and in-vitro methods may be employed [43-49]. Basis of the tests should be the Notes of Guidance for the check of safety of cosmetic products, annex 11 and 12 of the SCCNFP [50].

Test reactions may be objectified by means of non-invasive skin-physiological methods [49]. In combination and as complementation standardized wash- respectively controlled application tests (usage tests) may be performed [36, 43, 46, 51].

The occlusive epicutaneous patch test is recommended [43, 46] as method for the risk assessment of an acute irritation. The chronical-cumulative irritation can be determined by the repetitive epicutaneous patch test as well as for cleaning agents also by means of the Duhring-Chamber Test [52]. Further findings about the irritation potential of skin cleansing products are furnished by the elbow wash test [53] and the forearm wash test [54].

In contrast to other preparations for external application, some acne care products may have an irritation potential which is to be subject to consideration owing to ingredients applied and effects aimed at. For tolerance tests of these products, special attention is therefore to be paid to a sufficiently high number of probands so that significant results are achieved when applying suited statistical methods.

In order to minimize a possible sensitization potential of dermocosmetics for the cleansing and care of skin prone to acne it is recommended to make a thorough selection of raw materials. The use of preservatives and other components the sensitization potential of which is rated as relatively high, should in particular be avoided if alternatives with lower sensitization potential are available.

Moreover, a tolerance test of ready-to-use products by means of a ROAT (Repeated Open Application Test) is suggestive. This test is in particular indicated if unclear positive reactions in the epicutaneous test have to be checked [55].

Relating to the study design for tolerance tests, the instructions contained in chapter 6 are to be equally considered.


8 Documentation

Information required for the assessment of the quality of a dermocosmetic for the cleaning respectively care of skin tending to acne should be documented by the producer respectively seller of the product and made available to expert circles.

This documentation should at least comprise information as to the following issues:

Dermocosmetics for the cleansing of skin tending to acne

  • Description of the galenical system with indication of ph-value as well as of the surfactant and the lipid moiety if applicable;
  • Proof of claimed effects beyond the general skin cleansing in the form of a comprehensive presentation by indicating of reference;
  • Summary of results of the tolerance tests performed by indicating the reference.

Dermocosmetics for the care of skin prone to acne

  • Description of the galenical system with indication of ph-value and the lipid moiety if applicable;
  • Effectiveness proofs for the properties attributed for the care of skin prone to acne in the form of a comprehensive presentation by indicating of reference;
  • Summary of the results of the tolerance tests performed by indicating of reference.

9 Literature

[1] Daniel F, Dreno B, Poli F, Auffret N, Beylot C, Bodokh I, Chivot M, Humbert P, Meynadier J, Clerson P, Humbert R, Berrou JP, Dropsy R: Descriptive epidemiological study of acne on scholar pupils in France during autumn 1996. Ann. Dermatol. Venereol. 127 (2000) 273-278

[2] Dreno B, Daniel F, Allaert FA, Aube I: Acne: evolution of the clinical practice and therapeutic management of acne between 1996 and 2000. Eur. J. Dermatol. 13 (2003) 166-170

[3] Dreno B, Poli F: Epidemiology of acne. Dermatology 206 (2003) 7-10

[4] Poli F, Dreno B, Verschoore M: An epidemiological study of acne in female adults: results of a survey conducted in France. J. Eur. Acad. Dermatol. Venereol. 15 (2001) 541-545

[5] Schäfer T, Nienhaus A, Vieluf D, Berger J, Ring J: Epidemiology of acne in the general population: the risk of smoking. Br. J. Dermatol. 145 (2001) 100-104

6] Plewig G, Kligman A: Acne and Rosacea, 3. Aufl., Springer, Berlin, Heidelberg (2000)

[7] Degreef H, Dooms-Goossens A: Acne cosmetica (author's transl.). J. Pharm. Belg. 34 (1979) 49-54

[8] Fulton JE Jr, Bradley S, Aqundez A, Black T: Non-comedogenic cosmetics. Cutis 17 (1976) 344-345, 349-351

[9] Humbert P: Induced acne. Rev. Prat. 52 (2002) 838-840

[10] Khanna N, Gupta SD: Acneiform eruptions after facial beauty treatment. Int. J. Dermatol. 38 (1999) 196-199

[11] Kligman AM, Mills OH Jr: "Acne cosmetica". Arch. Dermatol. 106 (1972) 843-850

[12] Mills OH Jr, Kligman AM: Comedogenicity of sunscreens. Experimental observations in rabbits. Arch. Dermatol. 118 (1982) 417-419

[13] Yaffee HS: Comment on "acne cosmetica". Arch. Dermatol. 107 (1973) 630

[14] Fritsch, P: Dermatologie und Venerologie, 2. Aufl., Springer , Berlin, Heidelberg (2004)

[15] Burke BM, Cunliffe WJ: The assessment of acne vulgaris — the Leeds technique. Br. J. Dermatol. 111 (1984) 83-92

[16] Mulder MM, Sigurdsson V, van Zuuren EJ, Klaassen EJ, Faber JA, de Wit JB, van Vloten WA: Psychosocial impact of acne vulgaris — evaluation of the relation between a change in clinical acne severity and psychosocial state. Dermatology 203 (2001) 124-130

[17] Newton JN, Mallon E, Klassen A, Ryan TJ, Finlay AY: The effectiveness of acne treatment: an assessment by patients of the outcome of therapy. Br. J. Dermatol. 137 (1997) 563-567

[18] Pierard-Franchimont C, Gaspard U, Lacante P, Rhoa M, Slachmuylders P, Pierard GE: A quantitative biometrological assessment of acne and hormonal evaluation in young women using a triphasic low-dose oral contraceptive containing gestodene. Eur. J. Contracept. Reprod. Health Care 5 (2000) 275-286

[19] Rizova E, Kligman AM: New photographic techniques for clinical evaluation of acne. J. Eur. Acad. Dermatol. Venereol. 15 (2001) Suppl. 3, 13-18

[20] Rizova E, Pagnoni PA, Stoudemayer T, Poncet M, Kligman AM: Polarized light photography and videomicroscopy greatly enhance the capability of estimating the therapeuic response to a topical retinoid (adapalene) in acne vulgaris. Cutis 68 (2001) 25-33

[21] Pierard-Franchimont C, Pierard GE: Physiopathological approach to seborrhea of the scalp. Ann. Dermatol. Venereol. 115 (1988) 451-453

[22] Motley RJ, Finlay AY: Practical use of a disability index in the routine management of acne. Clin. Exp. Dermatol. 17 (1992) 1-3

[23] Draelos Z: Cosmetics in Acne and Rosacea. Sem. Cut. Med. Surg. 20 (2001) 209-214

[24] Katoulis AC, Kakepis EM, Kintziou H, Kakepis ME, Stavrianeas NG: Comedogenity of cosmetics : a review. J. Eur. Acad. Dermatol. Venereol. 7 (1996) 115-119

[25] Bikowski J. The use of cleansers as therapeutic concomitants in various dermatologic disorders. Cutis. 68 (2001) Suppl.
5, 12-19

[26] Subramanyan K: Role of mild cleansing in the management of patient skin. Dermatol. Ther. 17 (2004) Suppl. 1, 26-34

[27] Yamamoto A, Takenouchi K, Ito M: Impaired water barrier function in acne vulgaris. Arch. Dermatol. Res. 287 (1995) 214-218

[28] Pechere M, Germanier L, Siegenthaler G, Pechere JC, Saurat JH: The antibacterial activity of topical retinoids: the case of retinaldehyde. Dermatology 205 (2002) 153-158

[29] Vienne MP, Ochando N, Borrel MT, Gall Y, Lauze C, Dupuy P: Retinaldehyde alleviates rosacea. Dermatology 199 (1999) Suppl. 1, 53-56

[30] Scherdin U, Rippke F, Nielsen J, Strassner M, Imadojemun A, Gärtner E, Korting HC, Bielfeldt S: In vivo assessment of the efficacy of a medical face care system in subjects with acne-prone skin. Int. J. Cosm. Sci. 26 (2004) 221-229

[31] Pierard GE, Nikkels-Tassoudji N, Arrese JE, Pierard-Franchimont C, Leveque JL: Dermoepidermal stimulation elicited by a betalipohydroxyacid: a comparison with salicylic acid and all-trans-retinoic acid. Dermatology 194 (1997) 398-401

[32] Leveque JL, Corcuff P, Rougier A, Pierard GE: Mechanism of action of a lipophilic salicylic acid derivate on normal skin. Eur. J. Dermatol. 12 (2002) 30-38

[33] Pierard GE, Rougier A: Nudging acne by topical beta-lipohydroxy acid (LHA), a new comedolytic agent. Eur. J. Dermatol. 12 (2002) 47-48

[34] Gehring W, Geier J, Gloor M: Untersuchungen über die austrocknende Wirkung verschiedener Tenside. Dermatol. Monatsschr. 177 (1991) 257-264

[35] Tronnier H, Kresken J, Jablonski K, Komp B: Haut und Beruf – Strategien zur Verhütung berufsbedingter Hauterkrankungen. Grosse Verlag, Berlin (1989)

[36] 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) 92-106

[37] Charbonnier V, Maibach HI: Open assay models (washing) for evaluating subclinical irritant dermatitis. Cosmetics and Toiletries (2001) 38-40

[38] Gehring W, Gloor M: Der repetitive Waschtest als Modell zur Beurteilung von Hautschutzpräparaten am Beispiel einer
dexpanthenolhaltigen Formulierung. Akt. Dermatol. 27 (2001) 279-284

[39] Fluhr JW, Gloor M, Merkel W, Warnecke J, Hoffler U, Lehmacher W, Glutsch J: Antibacterial and sebosuppressive efficacy of a combination of chloramphenicol and pale sulfonated shale oil. Multicentre, randomized, vehicle-controlled, double-blind study on 91 acne patients with acne papulopustulosa (Plewig and Kligman's grade II-III). Arzneimittelforschung 48 (1998) 188-196
[40] Kuss O, Diepgen TL: Proper statistical
analysis of transepidermal water loss (TEWL) measurements in bioengineering studies. Contact Dermatitis 39 (1998) 64-67

[41] Fluhr JW, Mao-Qiang M, Brown BE, Wertz PW, Crumrine D, Sundberg JP, Feingold KR, Elias PM: Glycerol regulates stratum corneum hydration in sebaceous gland deficient (asebia) mice. J. Invest. Dermatol. 120 (2003) 728-3

[42] Balato N, Lembo G, Cuccurullo FM, Patruno C, Nappa P, Ayala F: Acne and allergic contact dermatitis. Contact Dermatitis 34 (1996) 68-69

[43] Matthies W.: Dermatologische Testmethoden zur Bewertung der lokalen Verträglichkeit von Fertigprodukten - Die neue COLIPAGuideline als Beitrag zur Sicherheitsbewertung kosmetischer Mittel gemäß 6. Änderungsrichtlinie der EU-Kosmetik-Richtlinie. Dermatosen 45 (1997) 154-159

[44] de Brugerolle de Fraissinette A, Picarles V, Chibout S, Kolopp M, Medina J, Burtin P, Ebelin ME, Osborne S, Mayer FK, Spake A, Rosdy M, De Wever B, Ettlin RA, Cordier A: Predictivity of an in vitro model for acute and chronic skin irritation (SkinEthic®) applied to the testing of topical vehicles. Cell Bio. Toxicol. 15 (1999) 121-135

[45] Pittermann W: Tierversuchsfrei forschen mit dem Rindereuter-Modell. In-vitro-Haut und Schleimhauttests im Focus kosmetischer Forschung. Parfümerie und Kosmetik 80 (1999) 38-41 (Englische Version: In vitro skin and mucous membrane tests in the focus of cosmetics research: )

[46] COLIPA: Cosmetic product test guidelines for the assessment of human skin compatibility (1995)

[47] Muhrahata RI, Nicoll GA: Mildness testing for personal washing products. In: Aust LB (Hrsg.): Cosmetic Claims Substantiation. Marcel Dekker Inc., New York (1997) 153-169

[48] 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 (1996) 28-31

[49] Fischer T, Greif C, Wigger-Alberti W, Elsner P: Instrumentelle Methoden zur Bewertung der Sicherheit und Wirksamkeit von Kosmetika. Akt. Dermatol. 24 (1998) 243-250

[50] 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 (1999)

[51] Gloor M, Wasik B, Gehring W, Grieshaber R, Kleesz P, Fluhr JW: Cleansing, dehydrating, barrier-damaging and irritating hyperaemising effect of four detergent brands: comparative studies using standardised washing models. Skin Res. Technol. 10 (2004) 1-9

]52] Frosch, PJ., Kligman AM: The Duhring chamber. An improved technique for epicutaneous testing of irritant and allergic
reactions. Contact Dermatitis 5 (1979) 73-81

[53] Frosch PJ: Irritancy of soap and detergent bars. In: Frosch PJ, Horwitz S (Hrsg.): Principles of cosmetics for the dermatologist. Mosby, St Louis (1982) 5-12

[54] Nicoll GA, Muhrahata RI, Grove GL: The relative sensitivity of two arm wash test methods for evaluating the mildness of personal washing products. J. Soc. Cosm. Chem. 46 (1995) 129-140

[55] Hannuksela M, Salo, H: The repeated open application test (ROAT). Contact Dermatitis 14 (1986) 221-227


10 Processes for
achieving of consensus

This guideline has been elaborated by the department Dermocosmetics of the GD Gesellschaft für Dermopharmazie e. V. as consensus paper.

Authors in charge:

PD Dr. med. Joachim W. Fluhr, Jena
Dr. Hans W. Reinhardt, Offenbach
Dr. med. Frank Rippke, Hamburg

Released for publication: 1st April 2005

Actualization planned: April 2008


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