Tinea pedis MedDRA version: 9.1 Level: LLT Classification code 10043873 Term: Tinea pedis
Conditions
Interventions
Product Name: Terbinafin Creme 1%
Pharmaceutical Form: Cream
INN or Proposed INN: Terbinafine Hydrochloride
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 1
Sponsors
Dermapharm AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: males and females of at least 18 years of age written informed consent after being verbally informed by the investigator diagnosis of Tinea pedis interdigitalis confirmed by a positive microscopical native preparation with 30% caustic potash at least moderate severity of skin infection, i.e. patients must have score value of at least 4 (=sum score of the clinical parameters pruritus, erythema, desquamation, exudation, blisters and pustules, each rated on a scale of 0 to 3) Women of childbearing potential: Use of a highly effective contraception method for the duration of the study Women of childbearing potential: Negative pregnancy test prior to treatment start Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: topical treatment with antimycotic preparations in the test area during the 7 days prior to study inclusion systemic treatment with antimycotic preparations during the 4 weeks prior to study inclusion known intolerance of or hypersensitivity to terbinafine or any other ingredient of the study medication severe heart failure or circulatory failure, severy hepatic or renal insufficiency, severe respiratory insufficiency, neoplasm severe acute or chronic concomitant disease seriously affecting the general condition concomitant diseases which may -taking the present knowledge into account- influence the parameters assessed in the study in a way that would make an objective evaluation impossible concomitant medication which may -taking the present knowledge into account- influence the methods of measurement used in this study or the resulting data well-founded doubt regarding the cooperation of the patient dementia or any other severe intellectual impairment which makes a sound assessment of the patient history or a sound self-assessment impossible excessive consumption of alcohol, illegal drugs, medicaments or nicotine participation in another clinical trial within 30 days prior to inclusion or during this study former participation in this clinical trial pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of the efficacy and tolerability of the new preparation Terbinafine Creme 1% vs. the approved preparation Lamisil(R) vs. vehicle in patients with Tinea pedis. Primary efficacy variable: Proportion of patients with clinical and mycological treatment success at study end (day 21). ;Secondary Objective: Secondary efficacy variables: Proportion of patients with clinical and mycological treatment success at the end of the treatment phase (day 7) Change of the sum of scores of the symptoms pruritus, erythema, desquamation, exudation, blisters and pustules between day 0 and day 7 as well as between day 0 and day 21 Change of the scores of the individual symptoms pruritus, erythema, desquamation, exudation, blisters and pustules between day 0 and day 7 as well as between day 0 and day 21 Proportion of patients with mycologically successful treatment at day 7 and at day 21 Proportion of patients with clinically successful treatment at day 7 and at day 21 Proportion of patients with relapse at day 21 Global evaluation of the therapeutic success in the test area by investigator and patient at day 7 and at day 21 Safety Global evaluation of tolerability by investigator and patient at day 7 Adverse Events;Primary end point(s): Primary efficacy variable: Proportion of patients with clinical and mycological treatment success at study end (day 21). | — |
Countries
Germany
Outcome results
None listed