Clinical Study Synopsis

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1 Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare Professionals should always refer to the specific labeling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. The results from a single study may not reflect the overall results for a drug. The following information is the property of Bayer HealthCare AG. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare AG. Commercial use of the information is only possible with the written permission of the proprietor and is subject to a license fee. Please note that the General Conditions of Use and the Privacy Statement of bayerhealthcare.com apply to the contents of this file.

2 Clinical Trial Results Synopsis Study Design Description Study Sponsor: Bayer Healthcare AG Study Number: 0472 NCT Study Phase: III Official Study Title: Double-blinded, controlled trial comparing the onychoset treatment with a combined topical/oral treatment in onychomycoses. Therapeutic Area: Anti-Infectives Test Product Name of Test Product: Mycospor / Canesten Extra (Bifonazole, BAYH4502) Urea Ointment 40% Mycospor / Canesten Extra (Bifonazole, BAYH4502) Cream 1 % Bifonazole (BAYH4502) 1% Griseofulvin 500mg tablets Name of Active Ingredient: Dose and Mode of Administration: Ointment: BAY H %-urea 40% Cream: BAY H % Tablets: Griseofulvin 500mg BAY H %-urea 40% ointment was applied topically once daily under occlusive dressing until removal of infected nails. This was followed by a topical application of BAY H % cream applied to the nail bed once daily and gently rubbed in, concomitantly with oral, once daily Griseofulvin 500mg tablets. Reference Therapy/Placebo Reference Therapy: Mycospor / Canesten Extra (Bifonazole, BAYH4502) Urea Ointment 40% Mycospor / Canesten Extra (Bifonazole, BAYH4502) Cream 1 % Bifonazole (BAYH4502) 1% Griseofulvin placebo tablets Dose and Mode of Administration: BAY H %-urea 40% ointment was applied topically once daily under occlusive dressing until removal of infected nails. This was followed by a topical application of BAY H % cream applied to the nail bed once daily and gently rubbed in, concomitantly with oral, once daily Griseofulvin placebo tablets. Page 1 of 5

3 Duration of Treatment: BAY H %-urea 40% ointment was applied until removal of infected nails, followed by BAY H 4502 cream 1% with 500mg Griseofulvin or placebo tablets orally for four weeks. Studied period: Date of first subjects first visit: May 1991 Date of last subjects last visit: August 1992 Study Center(s): The study was conducted at a single site in Israel. Methodology: This was a randomized, double-blind parallel group comparison between combined topical/oral treatment of BAY H %-urea 40% ointment plus placebo and BAY H %-urea 40% plus Griseofulvin tablets. BAY H %-urea 40% ointment was applied topically once daily under occlusive dressing until removal of infected nails. This was followed by combined topical/oral treatment of BAY H 4502 cream 1% with either Griseofulvin 500mg tablets or placebo tablets, respectively for four weeks. A total of 120 subjects, 60 subjects in each of two treatment groups, were enrolled. The groups were identified as treatment group A (BAY H %-urea 40% ointment ; BAY H 4502 cream 1% with Griseofulvin 500mg tablets) and treatment group B ( BAY H %- urea 40% ointment; BAY H 4502 cream 1% with placebo tablets). Subjects fulfilling the inclusion criteria were randomly allocated to either of the two treatment groups in sequence of appearance. Mycological (microscopic and culture) and clinical examination were conducted before start of treatment. The mycological examination was repeated after nail removal, and at three days and four weeks after end of treatment. The mycological and clinical examination were repeated at four months after end of treatment. Removal of material for mycological examination was done from same location as the first time. Complete blood count was done in subjects before and after termination of the four-week-treatment with Griseofulvin/BAY H 4502 cream 1%. Subjects were instructed to contact the investigator during the followup period if first signs of relapse occur. Subjects were evaluated for adverse reactions. The results were assessed based on the evaluation of clinical (regrowth of nail) and mycological findings. Indication/ Indication: onychomycosis Main Inclusion Criteria: Inclusion criteria: subjects over the age of 16 years positive mycological findings in the native preparation (KOH preparation) before the start of treatment confirmation of microscopic findings by culture with identification of the pathogen fungus Page 2 of 5

4 Study Objectives: positive clinical findings subjects must have had one nail completely infected (target nail) subjects with not more than three infected nails to be treated at the same time Overall: To study the efficacy (mycological and clinical) and tolerability of BAY H 1%-urea 40% and BAY H % cream treatment in comparison with combined topical/oral BAY H %-urea 40% and BAY H % cream / Griseofulvin treatment in onychomycoses. Primary: To demonstrate efficacy (clinical and mycological) and tolerability of BAY H 4502-urea ointment in onychomycoses by non-traumatic onychectomy with BAY H 4502-urea ointment, followed by treatment of the nail bed with BAY H 4502 cream 1% and either Griseofulvin or placebo tablets. Secondary: To assess the acceptability of therapy by the subjects. To demonstrate differences between both treatment groups with respect to efficacy (end of treatment) and recurrence (end of followup period). Evaluation Criteria: Efficacy (Primary): The study results were correlated based on the clinical and mycological findings of the target nail. The efficacy evaluated according to following parameters: cure: clinical and mycological cure (culture negative) at both investigation times one and four months after end of treatment. improvement: clinical improvement, mycological cure (culture negative) at both investigation times one and four months after end of treatment. failure: mycological failure (culture positive one month after end of treatment) relapse: Change from negative findings one month after end of treatment to positive findings four months after end of treatment. Efficacy (Secondary): The acceptability of the therapy was determined by the investigator by monitoring the compliance (unused drug was returned by the subject and counted by the investigator) and recording the reason for leaving the study. Subjects were instructed to contact the investigator during the followup period if first signs of relapse occured. Page 3 of 5

5 Safety: The adverse reactions were graded as mild, moderate or severe by the investigator. Statistical Methods: Efficacy (Primary) - if applicable: Assessment of sample size: Based on the assumptions of a failure rate (failure + relapse) of 30 % with BAY H 4502 cream 1% alone and of 10% with BAY H 4502 cream 1% + Griseofulvin tablets, α= 0.05 and β= 0.2 the needed sample size was 58 subjects for each treatment group (Casagrande formula, one-sided test). Efficacy analysis: The primary efficacy variable "assessment of treatment" (cure + improvement versus failure + relapse) were tested for treatment differences by Fisher's exact test (alpha= 0.05, onesided test (no advantage with additional systemic therapy of Griseofulvin). Additionally the relapse rates of both treatments were tested exploratively in the same way as the primary efficacy variable. All other data were analyzed descriptively. The comparability of the two treatment groups was checked with regard to age and weight univariately by one-way-analysis of variance and with regard to duration of mycosis by an exact contingency table test. Safety: Data regarding tolerability of the drug was collected. Number of Subjects: The study included 120 subjects, 60 subjects in each treatment group. Ninety-eight subjects were included in the evaluation. Twenty two subjects (12 in the BAY H 4502 cream 1%+Griseofulvin and 10 in the BAY H 4502 cream 1%+Placebo treatment) had to be excluded from the efficacy analysis because of incomplete data. Study Results Results Summary Subject Disposition and Baseline The study enrolled 120 subjects of either sex with evidence (clinically and mycologically) of onychomycoses on hands and/or feet. Ninety-eight subjects were included in the evaluation: 48 subjects in the BAY H 4502 cream 1% + Griseofulvin group and 50 in the BAY H 4502 cream 1% + placebo group. Twenty two subjects (12 in the BAY H 4502 cream 1% + Griseofulvin and 10 in the BAY H 4502 cream 1% + Placebo) were excluded from the efficacy analysis because of incomplete data. The median values for age, body height and body weight were 48 years, 170 cm and 70 kg in the BAY H 4502 cream 1% + Griseofulvin group, and 43 years, 168 cm and 67 kg in the BAY H 4502 cream 1% + placebo group, respectively. In the BAY H 4502 cream 1% + Griseofulvin group, 24 subjects were male and 24 female; in the BAY H 4502 cream 1% + placebo group these figures were 22 and 27 (data missing for one subject), respectively. Page 4 of 5

6 Results Summary Efficacy The median time until nail removal was 21 days. The primary key variable for efficacy of treatment was the mycological cure (negative culture) of the target nail. At the end of the treatment course, a mycological cure was obtained in 46 of 48 subjects (95%) of the BAY H 4502 cream 1% + Griseofulvin group and in 40 of 50 subjects (80%) of the BAY H 4502 cream 1% + placebo group. At one month after end of treatment these figures were 48 of 48 (100%) and 43 of 50 (86%), respectively. At the follow-up four months after end of treatment 45 of 48 subjects (93%) of the BAY H 4502 cream 1% + Griseofulvin and 33 of 50 subjects (66%) of the BAY H 4502 cream 1% + placebo group had negative culture findings. Negative cultures one and four months after end of treatment were observed in 45 and 31 subjects, respectively. This difference was statistically significant with a p-value of < 0.01 (confirmative analysis, exact Fisher-Test). The relapse rate was 7% (three subjects) in the BAY H 4502 cream 1% + Griseofulvin group and 20% (10 subjects) in the BAY H 4502 cream 1% + placebo group. This difference was statistically significant with a p-value of< 0.01 (exploratory analysis). Results Summary Safety Treatment was discontinued in one subject from the BAY H 4502 cream 1%+placebo group who reported local sensations. There were five subjects in the BAY H 4502 cream 1% + Griseofulvin group who reported adverse events. In three out of these five subjects, the adverse events were directly related to Griseofulvin (nausea, abdominal pain, drug eruption) and treatment was discontinued because of the adverse events. Conclusion In this study, (onychoset) BAY H %-urea 40% ointment + BAY H % cream treatment was found to be effective in treatment of onychomycoses. The addition of Griseofulvin tablets may increase the mycological cure rates and reduce the relapse rates. Date Created or Date Last Updated: 21-Aug-2011 Page 5 of 5

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