GD — Society for Dermopharmacy

Issue October 2000

After opening of the meeting by the GD's president, pharmacist, Dr. Joachim Kresken, Viersen, and the scientific head of the meeting, professor Dr. Frank Hevert, Freiburg, the president of the Deutsche Dermatologische Gesellschaft [DDG] (German Dermatologic Society) and director of the Universitäts-Hautklinik Freiburg (University Dermatological Clinic), Professor Dr. med. Erwin Schöpf, addressed greetings to the meeting participants. Schöpf designated the GD founded not until 1995 and in the meantime associated with the DDG as being "organized in an extraordinarily professional manner and exemplary for the DDG". He commended the responsibles having mobilized potentials from research and science, industry, clinical and practical dermatology as well as pharmacy with a high degree of commitment and motivation in order to establish a new significance for Dermopharmacy. Schöpf called the GD a "prime example for an indispensable feature also required and called for today in research, that is interdisciplinarity".

Schöpf criticized the health politics which come to armchair decisions regarding patients and their skin diseases without the required specialized knowledge. Skin diseases and their therapy are according to Schöpf a privilege of the dermatologists because of their know how developed over decades. The fact that progress achieved by industry directly supports the dermatologist represents among other objectives a matter of special concern for the GD. Thus they take into account actual necessities, canalize current trends and redirect a focus on the important but neglected subject of the dermatological physiology within the field of research. The GD carries the expectations for an impetus in dermatological research, according to Schöpf.

In Schöpf's opinion the psychical strain of patients suffering from skin diseases is not paid sufficiently attention to. "They feel "leprous", are socially isolated and their quality of life is impaired", Schöpf explained. Concerning this aspect research is just as necessary as for the fields of skin care, esthetical medicine and cosmetology. In contrast to American dermatology the main stress should under no circumstances be laid to cosmetology but it is important to maintain and extend the widespread spectrum and the competence in all questions of dermatology.



Schöpf also gave his opinion relating to extemporaneous preparations: "doubtless extemporaneous preparations are necessary. This requirements mainly applies to substances not being offered by industry". The fact that maximal quality standards have to be based for them is an obvious claim. Schöpf supports the GD's taking the "broad way" by practically integrating all fields of competence for dermopharmacy in its spectrum of activities. As a conclusion of his remarks he wishes the GD plenty of success concerning their future projects and all meeting participants coming from Germany, Austria, Switzerland, France, Finland and Sweden a pleasant course of the meeting.

New or simply different ways?

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The integration of the computer-aided "drug design" into the development of new dermatological drugs represents a relatively innovative trend in dermopharmacy. For Dr. Etienne Thoreau of Galderma's Research and Development Center in Sophia Antipolis, France it represents an advantage to be able to produce far more selectively effective substances. He made this clear for substances which bind to retinoids-, vitamin D respectively steroid hormone receptors. In the last years the three-dimensional structure of the ligand-binding zones of several of these receptors has been clarified by means of the x-ray-structural analysis and thus the prerequisite has been generated for the "molecular modelling" of potential agonists and antagonists of these receptors.

A novel way for the treatment of the atopical dermatitis is the application of topical immunomodulators. The first substance of this drug class not yet authorized in Europe is Tacrolimus developed by the company Fujisawa. It has shown in several randomized long- and short-term studies a high effectiveness and good tolerability for the atopical eczema. On the occasion of the GD's annual meeting professor Dr. Sakari Reitamo of the Universitäts-Hautklinik Helsinki (University Dermatologic Clinic) reported about his clinical experience with topically applied Tacrolimus. Please refer to the report "new Hope for atopical Dermatitis" for learning of reasons why Reitamo speaks for the application of Tacrolimus.

Biopharmacy and Dermatopharmacology

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Professor Dr. Reinhard Neubert of the department pharmacy at the Martin-Luther-University Halle-Wittenberg dealt with a biopharmaceutical subject. He spoke about the significance of multi-lamellar membranes in the penetration analysis of drugs for external application. In Neubert´s working group a multi-layer membrane system has been developed which can be used as method for measurement of liberation and penetration of active substances from semi-solid formulations. The wide range of application of this system has been shown with examples: on the one hand it has been used for examining of the mechanism for improvement of penetration by propylenglycol and on the other hand for the optimization of penetration by erythromycin from a gel preparation as well as from urea in w/o creams.

Dermatological topics were subject of the presentation by the lecturer Dr. med. Rolf Hoffmann, Dermatologische Klinik der Philipps-Universität Marburg (Dermatological Clinic of Philipps-University) and Dr. med. Martin Schaller, Dermatologische Klinik und Poliklinik der Ludwig-Maximilians-Universität München (Dermatological and Outpatients' Clinic). Hoffmann's subject was the pharmacological influencing of the androgen metabolism in skin. Clear evidence is available for the effect of topically applied inhibitors of 5-alpha-reductase, as progesterone on the sebum excretion of the sebaceous glands. Whereas an inhibition of this enzyme for hair follicles has only been proven for the systemical application of Finasterid. The possibility of a selective inhibition of other enzymes of the steroid metabolism supplies impulses for new therapy possibilities for acne and the androgenetic alopecia. Schaller presented the results of a potency test of two Econazol-containing preparations for external application in a candidose model on the basis of reconstructed human epidermis. According to this model a liposomal Econazol gel has shown a better effectiveness than a cream preparation with the same active substance. Schaller attributed this result to a better penetration and stronger affinity of the liposom gel with respect to Candida albicans.

Cosmetical active substances in test

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Dr. Thomas Förster of Henkel Düsseldorf has given an overview of the active substance research by the cosmetic industry. As Förster explained, the systematic assessment of new cosmetical active substances is performed in three stages: in the beginning there is the substance screening with tests to be rapidly executed on simple skin cell cultures, followed by tests at in-vitro skin models and finally the dermatological test is performed in a consumer panel. The in-vitro-full-thickness models which have been introduced in individual research departments of the cosmetical industry in the meantime are epochal achievements according to Förster. They open up new ways in order to allow for example the examining of the influence by cosmetical raw materials and ready-to-use preparations on skin ageing. Förster presented the results of a potency test for a phytokin from the soy bean plant for which an increase of the collagen synthesis by 37 per cent could be shown by means of an full-thickness model established in his working group. This result could be confirmed in a subsequent dermatological analysis: a phytokin-containing cream showed an increase of the collagen content in skin by 29 per cent and a reduction of the wrinkle depth in the area of the canthus by 16 per cent after an application period of two weeks.

The topic of the lecture by Dr. med. Frank Rippke of Beiersdorf, Hamburg has been lactic acid as cosmetical effective principle for a specific follicular keratolysis. Rippke presented the results of a clinical study in which the effectiveness of a care system usual in the trade containing two per cent lactic acid in a special galenic basis has been tested at 90 probationers for acne comedonica and acne papulo-pustulosa. After a three-months' application the preparation lead to a reduction of the number of comedones by 56 per cent connected with an increase of quality of life by 46 per cent. The content of lactic acid analysed in follicle biopsies had increased by 60 to 70 per cent through the treatment. Unwanted side effects as skin irritations could not be observed according to Rippke's statements. Thus the preparation allows a clinically effective care treatment of minor acne forms without the otherwise typical skin irritations.

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An additional priority of the meeting has been occupational skin protection. Dr. Bernard Gabard of Spirig, Egerkingen in Switzerland presented a skin protective preparation for the development of which a concept normally usual for drugs has been adopted. In animal-experimental examinations a w/o cream with aluminum hydroxychloride and glycerine has proven as being most effective compared with the model irritant sodium lauryl sulfate and a cool lubricant from a multitude of development formulations. The protective effect towards the sodium lauryl sulfate has been confirmed in the probationer model whereas no protective effect has been found with acetone in a different human model. Gabard assessed this result as a sign of a relatively specific effective spectrum as already known from other occupational skin protective preparations.



A supplementary indispensable aspect of the occupational skin protection in the workplace is skin cleansing. An especially mild cleansing of skin is required for persons with increased dirt stress. It has to be performed at the same time fast and thoroughly. This has been pointed out by graduate engineer Andreas Klotz of Stockhausen, Krefeld responsible for the biophysical test of occupational skin protective, skin cleansing and skin care preparations. Klotz explained the progress lately achieved relating to an amelioration of skin tolerability even for skin cleansers applied for the removal of heavy soilings by using two product examples. One of the two presented products was a hand cleansing preparation containing rubbing agents for heaviest soilings the cleansing effect of which is comparable to a solution-containing preparation. The solution agent of this preparation, however, has been exchanged by a skin friendly natural oil. The second preparation presented does not even require any rubbing agents for the removal of heavy soilings as for example fat, oil, soot or graphite and is therefore, according to Klotz, due to dermatological points of view especially recommendable.

Additional information concerning the subject Occupational Dermatoses and Skin Protection and answers to the question which possibilities this field offers to the practicing dermatologist can be referred to in the chapter "News of Dermopharmacy" in this online-version.

Authorization of Dermatics

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In the meantime it has become general practice that also representatives of national or European authorities are heard at the GD's annual meetings. This year Professor Dr. med. Achim Zesch of the Bundesinstitut für Arzneimittel und Medizinprodukte in Berlin (Federal Institute for Drugs and Medicinal Products) gave his opinion about the basic priniciples of authorization for dermatics in Europe. Before being allowed to place dermatics on the market, their effectiveness, tolerability and pharmaceutical quality has to be proven by the producer as provided for all drugs.

As Zesch explained dermatics for topical application have a favorable starting situation regarding their benefit-risk consideration to be performed for each drug. Concerning their clinical analysis besides their effectiveness attention has to be paid to local and in case of possible percutaneous resorption moreover to systemical side and interactions. Furthermore, special features have to be considered for certain preparations for external application: if for example for a new glucocorticoid the claim has been raised to have less side effects than other glucocorticoids of the same potency strength then this fact has to be proven by corresponding comparison analyses. In addition, the local tolerability of basics has to be checked at the active-agent-free vehicle in order to exclude that possible intolerabilities are masked by the active substance.

News in Dermatotherapy

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Professor Dr. med. Jean Krutmann, expert in the field photodermatology at the Hautklinik Heinrich-Heine-Universität, Düsseldorf (Dermatological Clinic, Heinrich-Heine-University) reported about news regarding the PUVA-therapy (psoralen plus UVA). As the extraordinary effectiveness of the PUVA-therapy has been known for example for the treatment of the psoriasis since the sixties, at present a cream-PUVA-therapy is being developed.

Due to the fact that the radiation optimum is obtained approximately 60 minutes after the cream application according to first examinations, it is possible that the patient applies the cream already at home. This represents without doubt an advantage in contrast to the customary bathing-PUVA-therapy performed so far. Krutmann is satisfied with the results of a study achieved in the meantime at patients with chronical-recurrent hand and foot eczema. Most of the patients treated have shown a complete remission after the cream-PUVA-therapy. Before standardizing of the cream-PUVA-therapy further development of a galenic stable formulation is necessary.

Professor Dr. med. Dietrich Abeck of the Klinik und Poliklinik der Technischen Universität München (Clinic and Outpatients' Clinic of the Technical University Munich) reported of current aspects regarding the therapy management of the atopical eczema. Essential for an improvement of the atopical eczema are measures for the stabilization of the skin barrier for which mainly active-agent-free preparations for the topical application are to be considered. Besides preparations qualified for prescription there is a multitude of innovative, galenical high-quality care products which are not qualified for refunding however can be recommended for self-medication. Application and selection of preparations have to be performed in dependence on the current skin findings. Thus for instance the fat-humid treatment has proven very effective in case of acute exacerbative courses. Additives having antimicrobial, antipruriginous and hydration enhancing effects could further ameliorate the positive effects of the fat-humid treatment of the atopical eczema.

Uncontested success could also be achieved with the substance Minoxidil for the topical treatment of the androgentic alopecia according to private lecturer Dr. med. Hans Wolff of the Dermatologische Klinik und Poliklinik der Ludwig-Maximilians-Universität München (Dermatological Clinic and Outpatients' Clinic of the Ludwig-Maximilians-University Munich) in the last major lecture of the meeting. For further information as to when, why and how the new Minoxidil-containing preparation Regaine™ takes effect please refer to the report "New topical Therapy of the androgenetic Alopecia (in German)". The report "Proven Therapeutic rediscovered (in Gernan)" contains information regarding the synthetic tanning agent Tamol which has been presented in a satellite symposium organized by the company Galderma. Finally, we report about a workshop which has dealt with the Significance of Pharmaco-economy within Dermatology. The next edition of DermoTopics will contain information as to the two additional workshops of the first congress day which have been prepared by the GD departments Extemporaneous Preparations and Dermocosmetics.

Good bye and meeting again in Zurich

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The concluding word of the 4th annual meeting was spoken by the GD vice-president, Professor Dr. med. Hans Christian Korting of the Dermatologische Klinik und Poliklinik der Ludwig-Maximilians-Universität München (Dermatological Clinic and Outpatients' Clinic of the Ludwig-Maximilians-University Munich). He summarized the scientific program prepared by professor Hevert and himself and expressed his thanks to all persons responsible for the organization and execution of the meeting.

In conclusion, Korting invited all participants to attend the GD's 5th annual meeting in Zurich on 28 March 2001 which will take place for the first time abroad as a sign of the GD's international character. Lecturer Dr. Christian Surber of the Kantonsspital Basel (Canton Clinic of Basle) is responsible for the scientific organization of this meeting. Dr. Surber is being considered as expert in the field of the scientific and applied dermopharmacy. (ghw/jk)

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