Bayer AG : Not for US or UK use! – New data presented at EADV Congress 2011

by Symptom Advice on October 26, 2011

Lisbon, Portugal, October 21, 2011

– Isoconazole nitrate is not only a potent antifungal agent, but may also be effective against a broad range of bacteria which can cause bacterial superinfection of dermatomycoses. this is the result of an in vitro study previously presented by Intendis as a poster(1) at the EADV Congress 2011 in Lisbon, Portugal.

Microbic (fungal and/or bacterial) infections of the skin and nails form are very widespread. for instance, in the last few decades, the prevalence of superficial mycotic infections has risen effecting approximately 20 to 25 percent of the world’s population(2). Due to their widespread and contagious nature, such infections require an effective antimicrobial treatment that can both reduce morbidity and discomfort and limit the spread of the disease to other sites or individuals. Isoconazole nitrate is highly effective in the treatment of the vast majority of pathogenic organisms implicated in superficial infections of the skin, including dermatophytes, yeast and moulds. the study results presented are evidence of a bacteriostatic and bactericidal action of isoconazole nitrate against a broader range of potentially pathogenic bacterial species such as Staphylococcus aureus, Staphylococcus haemolyticus, Propionibacterium acnes and Corynebateria tuberculostearicum. Interestingly, isoconazole was also effective in inhibiting a multiresistant Staphylococcus aureus strain (MRSA).

“Our results show that the antimicrobial range of isoconazole is broader than previously supposed,” said Dr. Viktor Czaika, Department of Dermatology and Allergy, Charit? – Universit?tsmedizin, Head of Section Dermatology – Campus Benjamin Franklin, Berlin, Germany, and corresponding author of the study. “The compound provides fast and effective treatment of superficial mycotic and/or bacterial infections.”

the study design

in the study several aspects of the antibacterial action of isconazole nitrate were evaluated:

(i) the minimal inhibition concentration against bacteria strains from the microorganisms culture collection of the German Resource Centre for Biological Material DSMZ as reference strains as well as against isolates was determined using the broth dilution method. (ii) the bactericidal activity was evaluated by counting cells stained with Hoechst 33342 (Invitrogen, USA) or propidium iodide (Roth, Germany). Using this method the change in number of dead and living bacteria could be differentiated. (iii) Furthermore, killing curves were identified.

To evaluate a possible mode of action, reactive oxygen species production of S. aureus was determined. in this experiments bacteria were stained with singlet oxygen sensor green (Invitrogen, USA) after the incubation with isoconazole nitrate.

the study demonstrates a broad bacteriostatic and bactericidal action of Isoconazole nitrate against gram positive bacteria. in addition to the current literature the study demonstrated action against S. epidermidis, S. haemolyticus, Strept. salivarius, Coryneb. tuberculostearicum, P. acnes as well as a multiresistant S. aureus strain. the antibacterial effect might be attributed to the production of reactive oxygen species (ROS).

About superficial microbic infections

Superficial microbic (mycotic and/or bacterial) infections of the skin are common and ubiquitous, affecting millions of people worldwide, irrespective of skin type and age group. the most common pathogens relevant to clinical practice can be subdivided into four groups: dermatophytes, yeasts, moulds and gram positive bacteria. the chief symptoms experienced by patients with superficial microbic infections are itching, burning and redness. Intendis markets products for superficial fungal infections of the hands, the interdigital spaces of the feet and in the inguinal region and the skin of the genital regions. another indication is the initial or interim treatment of those superficial fungal infections that are accompanied by highly inflammatory or eczematous skin changes.

About Isoconazole nitrate at EADV 2011

PO158 – Bacteriostatic and bactericidal effects of isoconazole nitrate

V. Czaika, J. Siebenbrock, M. Friedrich, F. Czekalla, B. N??lein, M. Sieber (Berlin, Germany)

the results of this in vitro study shows that Isoconazole nitrate has antibacterial activity against a broader range of gram-positive bacteria than previously known.

PO182 – Analysis of penetration and storage of Isoconazole nitrate in the stratum corneum and the hair follicles after regular application of anti-mycotic drug

J. Lademann, A. Patzelt, S. Schanzer, H. Richter, G. Thiede, B. Havlickova, C. Guenther, M. Friedrich, S. Seifert, J.W. Fluhr (Berlin, Germany)

the in vivo study demonstrates that hair follicles represent excellent long-term reservoirs for topically applied Isoconazole nitrate which is of clinical importance where a long-lasting therapeutic effect beyond the application time is required, e.g. for prevention of re-infection.

PO1357 – Isoconazole nitrate versus isoconazole nitrate and diflucortolone valerate in the treatment of tinea inguinalis: Results of a multicentre retrospective study

S. Veraldi, M.C. Persico, R. Schianchi (Milan, Italy)

this clinical study in patients with tinea inguinalis demonstrates that the use of a combination therapy of an antimycotic and corticoid leads to a significantly faster relief of inflammation including faster relief of pruritus compared to monotherapy with a pure antimycotic.

Travocort contains 1% diflurcortolone valerate and 0.1% isoconazole nitrate in a cream with good emollient properties. Isoconazole nitrate, the antifungal component of Travocort?, belongs to the N-substituted imidazole class of antimycotic agents. Isoconazole nitrate has a broad fungistatic and fungicide activity and is active against gram positive bacteria. the efficacy of isoconazole nitrate in the treatment of dermatomycoses has been shown in a series of three controlled, multi-centre studies, with cure rates of 90-94%. Diflurcortolone valerate, the second active ingredient of Travocort is a class III-corticosteroid with demonstrated rapid onset of action and safety. Its anti-inflammatory effect is of particular benefit in counteracting the pruritus commonly experienced by patients with superficial microbic infections.(3) the product is marketed in 70 countries over the world.

Intendis is an integrated pharmaceutical business with its headquarters in Berlin, Germany. it has annual sales of EUR 300 million (2010). Intendis is part of Bayer HealthCare and completely dedicated to dermatology. the company focuses on the development, manufacturing and marketing of high quality, innovative topical therapies, targeted to treat skin disorders. the current product portfolio comprises treatments of eczematous disorders including atopic dermatitis, psoriasis, acne, rosacea, hemorrhoidal disease and fungal skin infections (mycoses). Find out more at .

About Bayer HealthCare

the Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. the company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at


Forward-Looking Statements

this release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . the company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

(1) PO158 – Bacteriostatic and bactericidal effects of isoconazole nitrate, V. Czaika, J. Siebenbrock, M. Friedrich, F. Czekalla, B. N??lein, M. Sieber (Berlin, Germany)

(3) Schropl, F.; Travocort/Travogen cream. Multicentre clinical study. Travocort/Travogen Workshop, Experta Medica 1980 Amsterdam.

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