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Issue March 2001

Topical Terbinafin
High Compliance by Short Duration of Treatment

Dermatomycoses, especially mycoses pedis, belong to the numerically most significant infectious diseases. Due to their frequent incidence and considerable contagiousness of the disease, medicaments are useful which are easily accessible to patients and feature a high compliance. An example in this context is the topical antimycotic agent Terbinafin(Lamisil®-cream) which is no longer available on prescription only as of 1 January of this year and since then also available for self-medication. DermoTopics asked the chairman of the Deutschsprachigen Mykologischen Gesellschaft (German-language Mycologic Society), professor Dr. med. Hans Christian Korting from the Dermatologische Klinik und Poliklinik (Dermatological Clinic and Outpatient Clinic)of the Ludwig-Maximilians-Universität Munich for background information.

DermoTopics:The topical antimycotic Terbinafin can be purchased over-the-counter in pharmacies since the beginning of this year. What are the special properties of Terbinafin, by which features does it distinguish itself from other preparations?

Professor Korting:
Terbinafin belongs to the substance class of the allylamines effective against numerous medicinal significant dermatophytes. The major difference compared with the azoles consists in the fact that allylamines have a fungicidal effect while azoles only have a fungistatic effect. Terbinafin is topically available in form of a cream which has been subject to prescription for years and is especially suitable for the treatment of fungal infections in the foot area. These diseases had been conventionally treated by using azoles in most cases. In a comparable assessment, however, it can be realized that controlled studies have revealed a superiority of the Terbinafin-cream in contrast to the Clotrimazole-cream for the target treatment athlete's foot respectively tinea pedis. A central study has been published in this context by the well-known English mycologist Evans and colleagues in the British Medical Journal. A study forms here the basis in the course of which a one-percent Terbinafin-cream has been applied on one side twice a day and for controlling purposes a one-percent Clotrimazole-cream on the other side for a duration of four weeks for the target disease tinea pedis. It has been shown that in fact the one-week treatment with Terbinafin has been more effective than the four-week treatment with Clotrimazole. In this respect I see an essential progress of particular significance for self-medication for which the same compliance frequently cannot be achieved as in the prescription sector.

Professor Dr. med. Hans Christian Korting, Chairman of the Deutschsprachigen Mykologischen Gesellschaft (German-language Mycological Society), explains the preferences of a Terbinafin-cream in the topical treatment of dermatomycoses.

DermoTopics: What is the incidence rate of the target disease tinea pedis in the population?

Professor Korting:
Tinea pedis is one of the most frequent diseases in general. For a long time we have not been aware of the frequency of this disease in everyday life. In the last years, however, we have gained much more detailed information by means of a European research project designated as Achilles project. In the frame of this project it had been checked in numerous dermatological practices on the basis of unselected medical documents concerning patients which had consulted the dermatologist for what reason ever whether the disease at issue has been the athlete's foot disease. The following surprising result has been achieved in the project: Approximately 10 percent of the patients suffered from a fungal disease at the free part of the foot, especially in the interdigital space, an additional ten percent at the foot nail organs, thus an onychomycosis, a further ten percent were afflicted with a combination of both diseases. Therefore it can be said that about thirty percent of the population has such a fungal disease of the foot at the free skin. An important number! In this context it has to be emphasized that fungal diseases in the foot area have to be taken unconditionally seriously. There are not always distinct symptoms. Reddening and scales can be the reason for a dermatologist consultation, more frequently, however, is the itching if it is very painful. Usually, however, the symptoms are so discreet that the disease is not regarded as problematic. Nevertheless, a nail disease with considerable consequences can develop very easily emanating from an infection of the interdigits. From investigations regarding the quality of life we know today that an onychomycosis can entail a major impairment, for example strong pain when walking. A significant target therefore is already the prevention from this disease.

DermoTopics: Is the onychomycosis the sole consequence of a primary fungal disease at the free skin of the foot?

Professor Korting:
No, definitely not. In 1999 a very important study of a French research group around Dupuy was published in the British Medical Journal dealing with the high-risk factors relating to an important bacterially conditioned disease that is the erysipelas of the lower leg connected with considerable impairment, high temperature and usually the necessity of a stay in a hospital or clinic. Remarkably frequent is the coincidence of the erysipelas with changes in the forefoot area, finally jointly causing an impairment of the epidermal barrier, i.e. whenever the skin is no longer intact for instance due to a foot mycosis disease, bacteria can penetrate more easily in deeper tissue layers and induce this impressive secondary disease.

DermoTopics: Your explanations clarify the big demand of antimycotics and corresponding therapy strategies. Which benefits and risks do you see in the fact that topical Terbinafin can now also be purchased without medical prescription in the pharmacy?

Professor Korting:
The benefit consists in placing a highly effective preparation now directly at the patients' disposal supported by a consultation in the pharmacy. A possible risk can consist in the arising of unwanted effects or changing of the resistance factor. The several years' use in the frame of the exlusive prescription availability, however, has shown that the Terbinafin-cream is a very well tolerable medicament. Equally so far no essential indications have arisen for a resistance development towards allylamines. This is why it is comprehensible that there is no longer a necessity for selling the preparation as an ethical drug.

DermoTopics: Which special task befits the pharmacy recommending the antimycotic to the patient?

Professor Korting:
Antimycotics have already been applied in self-medication on a large scale, especially for the treatment of the target disease tinea pedis. In view of the frequency of this disease it is comprehensible that in many cases it is primarily discussed by the patient with the pharmacist advising him in the matter in question. This immediate offer to the patients bears undoubtedly benefits as well as disadvantages. The advantage is that the patient gets direct help. A highly-effective medicament as the Terbinafin-cream is definitely able to cure the majority of the patients. A possible disadvantage, however, is also to be taken into consideration: The dermatologist has the possibility to gain material regarding the mycological diagnostics based on two pillars, the native preparation and the culture. This is in fact not possible in the public pharmacy so that in a series of cases it is impossible to safely establish whether or not it is really a question of a fungal disease. Under no circumstances it should be overlooked that also other inflammatory skin diseases for example the atopical eczema especially in the quite often affected region of the interdigits can cause very similar symptoms (reddening, scales, maceration) as it is the case for a mycosis. Summarizing it cannot be generally recommended to abstain from seeking a physician's or dermatologist's advice relating to a tinea pedis disease. In order to safeguard the interests of public health it is out of the question that an important additional therapeutic option is given by means of the self-medication.

Professor Dr. med. Korting and Co-worker performing Mycological Diagnostics in the Clinic Laboratory.

DermoTopics: What is the required treatment duration for tinea pedis with Terbinafin?

Professor Korting:
For the commercial Terbinafin-cream a one-week duration of treatment has been established. This is in contrast to the several weeks' treatment with the common azole creams. After discontinuing the application of the Terbinafin-cream, considerable active substance quantities are still stored in the skin so that the effect continues. However, in principle, it is advisable to recommend the patient to consult a doctor if after two or three further weeks there has been no distinct improvement or recovery. An additional assessment by the specialist is then required and should comprise laboratory diagnostics since in the individual case it is difficult to classify discreet clinical pictures correctly. We know today that the most important pathogenic organism of mycoses in the interdigital space, the dermatophyte trichophytone rubrum, adapts better and better to the human host, i.e. inflammatory symptoms are getting less and less and yet the epidermal barrier can be impaired at a certain point of time so that the mycete can spread to other structures especially the nail region.

DermoTopics: Dermatomycoses are particularly characterized by a high relapse tendency. Which prophylactic measures can be recommended to the customer by the pharmacist?

Professor Korting:
The pharmacist will certainly point to possible risk factors in his consultation. It is well-known that the mentioned fungal diseases arise more frequently with people who wear certain air-impermeable footwear (e.g. rubber boots, gym shoes) due to the fact that a climate is produced offering the fungi optimal growth conditions. Such footware should not be worn all day but shoes of respiratory-active materials as leather instead. The necessity of a special hygiene of stockings and shoes is not proven. The present-day detergents already eliminate germs in a wash process at 60° C.

DermoTopics: Professor Korting, we thank you for this conversation. (ghw)


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