GD — Society for Dermopharmacy

Issue 1 (2005)

Dermocosmetics
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

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1 Preamble

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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.

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2 Definition dermocosmetics

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.

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3 Target group and purpose

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.

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4 Definition of skin prone to acne

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).

Causes

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].

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5 Formulations and ingredients

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.

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6 Wanted effects and
effectiveness proof

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].

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7 Unwanted effects and
tolerance proofs

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.

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8 Documentation

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.
  

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10 Processes for
achieving of consensus

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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